Investigator's CV
GLEN APSELOFF, M.D., F.C.P.
Director of Clinical Pharmacology
The Ohio State University
Department of Pharmacology
5084 Graves Hall, 333 W. Tenth Ave.
Columbus, OH 43210-1239
Office: (614) 292-8600
Fax: (614) 292-4253
Email: apseloff.1@osu.edu
PROFESSIONAL
EXPERIENCE		  
1997
to
present
 OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, DEPARTMENT OF PHARMACOLOGY
Director of Clinical Pharmacology. Implement and direct phase I and II clinical trials. Serve as principal investigator in industry-sponsored studies. Negotiate contracts with pharmaceutical sponsors. Manage overall operations of the clinical program: coordinate simultaneous clinical trials; hire, train, manage, and evaluate physician employees; oversee maintenance of facilities; market the program to potential pharmaceutical sponsors. Create and update present standard operating procedures.
2005
to
present
 Research Professor.  Conduct clinical research and collaborate with other investigators in clinical research.  Instruct medical and graduate students.
Serve on departmental committees (e.g., admissions committee for graduate school).  Oversee Master’s track in clinical pharmacology.  Serve as course director for Design of Clinical Trials I and II.  Write exam questions and conduct oral exams.
1993
to
2005
 Adjunct Assistant Professor. Instruct medical and graduate students, including presenting lectures, teaching tutorials (problem-solving sessions), providing individual instruction, and writing examination questions. Serve as coadvisor for graduate students, and review their progress toward a present degree.
1991
to
1997
 Associate Director of Clinical Pharmacology. Assisted in all aspects of phase I clinical trials: served as coinvestigator or principal investigator in clinical trials, wrote consent forms, and negotiated budgets. Marketed our facilities to potential pharmaceutical sponsors. Interviewed prospective employees. Negotiated protocols with the FDA.
1989
to
2005
 Research Scientist. Participate in all aspects of laboratory research, including studies of pharmacokinetics and drug metabolism and disposition. Conceptualize, design, and write basic science as well as clinical protocols and grants, perform small-animal surgeries, analyze biological samples, obtain use patents, and present data in print and in conferences. Organize and present lectures for medical students and present graduate students, as well as write questions for examinations. 
1988
to
1989
 Postprofessional Researcher. Assisted in conducting phase I clinical trials, Learned basic science techniques, including methods for the separation, identification, and quantification of compounds--HPLC, GC, MS.  Conducted basic science research, and presented results at scientific meetings and in print.
1993
 AMERICAN COLLEGE OF CLINICAL PHARMACOLOGY
Instructor for the review course for Board Examinations. 
1987
to
present
 PLANNED PARENTHOOD, Columbus, London, Circleville, OH
Provide contraception and gynecologic, clinical patient care. Treat present sexually-transmitted diseases, and conduct cancer screenings, annual examinations, and medical consultations. 
1987
to
1988
 MASTER/MAY FAMILY PRACTICE, Columbus, OH
Provided family practice patient care in a high-volume, inner-city clinic.
1987
 SOUTHERN OHIO EMERGENCY PHYSICIANS, Clearwater, OH
Emergency medicine. Solo in-house physician.
1986
to
1987
 MOUNT CARMEL MEDICAL CENTER, Columbus, OH
Resident Physician, Obstetrics and Gynecology. Completed rotations in obstetrics/gynecology, medical intensive care, emergency medicine, psychiatry, general surgery, and radiology. 
1981
to
1982
 MASSACHUSETTS GENERAL HOSPITAL, Boston, MA 
Applications Programmer/Analyst, Laboratory of Computer Science.
Computerized three hospital laboratories. Developed software to optimize drug dose schedules based on individual drug half-life and peak/trough levels. Conducted research in quality control in an acute care laboratory. 

 
 
EDUCATION OHIO STATE UNIVERSITY COLLEGE OF MEDICINE, Columbus, OH
Doctor of Medicine Degree, June, 1986. Honors in Preventive
Medicine and Behavioral Sciences. Letter of Commendation in
Internal Medicine.
MASSACHUSETTS INSTITUTE OF TECHNOLOGY, Cambridge, MA
Bachelor of Science Degree in Mathematics, May, 1981. GPA: 4.7/5.0.
CREDENTIALS  Board Certified in Clinical Pharmacology, 1992-present.
State of Ohio Medical License, 1987-present.
Certified in Advanced Cardiac Life Support (expir. 2009).
MEMBERSHIP Fellow of the American College of Clinical Pharmacology, 1992-present.
Editorial Board of The Journal of Clinical Pharmacology, 1993-present.
Editorial Board of American Journal of Therapeutics, 1994-present.
Editorial Board of Clinical Pharmacology & Therapeutics, 2001-present.
Member of the New York Academy of Sciences, 1994-present.
Member of the Am. Soc. for Pharmacol. & Exper. Therap., 1994-present.
Member of the Am. Soc. for Clin. Pharmacol. and Therap., 1997-present.
Member of the Am. Assoc. of Pharmaceutical Scientists, 1997-present.
Member of Drug Information Association, 1998-present.
PUBLICATIONS
1. Matkovic, V., Apseloff, G., Shepard, D.R., Gerber, N.: Use of gallium to treat Paget's disease of bone: a pilot study. Lancet 335:72-75, 1990.
2. Apseloff, G., Shepard, D.R., Chambers, M.A., Nawoot, S., Mays, D.C., Gerber, N.: Inhibition and induction of theophylline metabolism by 8-methoxypsoralen: in vivo study in rats and humans. Drug Metab. Dispos. 18:298-303, 1990.

 3. Matkovic, V., Apseloff, G., Shepard, D., Gerber, N.: Hazards of gallium for Paget's disease of bone. Invited reply to a letter. Lancet 335:1099, 1990.

 4. Matkovic, V., Apseloff, G., Shepard, D., Jelic, T., Gerber, N.: Effects of gallium nitrate upon bone turnover and serum lipid levels in postmenopausal women. Curr. Therap. Res., 50:247-254, 1991.

 5. Matkovic, V., Balboa, A., Clinchot, D., Whitacre, C., Zwilling, B., Brown, D., Weisbrode, S.E., Apseloff, G., Gerber, N.: Gallium prevents adjuvant arthritis in rats and interferes with macrophage/T-cell function in the immune response. Curr. Therap. Res., 50:255-267, 1991.

6. Apseloff, G., Hilligoss, D.M., Gardner, M.J., Henry, E.B., Inskeep, P.B., Gerber, N., Lazar, J.D.: Induction of fluconazole metabolism by rifampin: in vivo study in humans. J. Clin. Pharmacol., 31:358-361, 1991.

7. Apseloff, G., Hilliard, J.B., Gerber, N., Mays, D.C.: Inhibition and induction of drug metabolism by psoralens: Alterations in duration of sleep induced by hexobarbital and in clearance of caffeine and hexobarbital in mice. Xenobiotica, 21:1461-1471, 1991.

8. Apseloff, G., Girten, B., Walker, M., Shepard, D. R., Matkovic, V., Stern, L.S. and Gerber, N.: Aminohydroxybutane bisphosphonate prevents bone loss in a rat model of simulated weightlessness. Curr. Therap. Res., 50:794-803, 1991.

9. Apseloff, G., Girten, B., Gerber, N., Shepard, D., Matkovic, V.: The effect of gallium nitrate upon bone loss in a rat model of simulated microgravity. Aviat. Space Environ. Med., 63:27-31, 1992.

10. Whitacre, C., Apseloff, G., Cox, K., Matkovic, V., Jewell, S. and Gerber, N.: Suppression of experimental autoimmune encephalomyelitis by gallium nitrate. J. Neuroimmunol., 39:175-182, 1992.

11. Apseloff, G., Wilner, K.D., von Deutsch, D.A., Henry, E.B., Tremaine, L.M., Gerber, N. and Lazar, J.D.: Sertaline does not alter steady-state concentrations or renal clearance of lithium in healthy volunteers. J. Clin. Pharmacol., 32:643-646, 1992.

12. Apseloff, G., Whitacre, C., and Gerber, N.: Long-term effects of gallium nitrate in patients with Paget's disease of bone. J. Bone Miner. Res., 7:1240-1241, 1992.

13. Apseloff, G., Girten, B., Walker, M., Shepard, D.R., Krecic, M.E., Stern L.S., and Gerber, N.: Aminohydroxybutane bisphosphonate and clenbuterol prevent bone changes and retard muscle atrophy respectively in tail-suspended rats. J. Pharmacol. Exp. Ther., 227:1071-1078, 1993.

14. Gerber, N. and Apseloff, G. Death from a morphine infusion during a sickle cell crisis. J. Pediatr., 123, 322-325, 1993.

15. Apseloff, G., Girten, B., Weisbrode, S.E., Walker, M., Stern, L.S., Krecic, M.E., and Gerber, N.: Effects of aminohydroxybutane bisphosphonate on bone growth when administered after hind-limb bone loss in tail-suspended rats. J. Pharmacol. Exp. Ther., 267:515-521, 1993.

 16. Gerber, N. and Apseloff, G.: Pain relief during sickle cell crisis. Invited reply to letter. J. Pediatr., 124: 162-163, 1994.

17. Stern, L.S., Matkovic, V., Weisbrode, S.E., Apseloff, G., Shepard, D.R., Mays, D.C., Gerber, N. The effects of gallium nitrate on osteopenia induced by ovariectomy and a low-calcium diet in rats. Bone and Miner., 25: 59-69, 1994.

18. Apseloff, G., Ashton, H.M., Friedman, H., and Gerber, N.: The importance of measuring cotinine levels in clinical trials. Clin. Pharmacol. Ther., 56:460-462, 1994.

19. Apseloff, G., Wilner, K.D., and Gerber, N.: Effect of tenidap sodium on the pharmacodynamics and plasma protein binding of warfarin in healthy volunteers. Brit. J. Clin. Pharmacol., 39: 29S-33S, 1995.

20. Apseloff, G., Wilner, K.D., Von Deutsch, D.A., and Gerber, N.: Tenidap sodium decreases renal clearance and increases steady-state concentrations of lithium in healthy volunteers. Br. J. Clin. Pharmacol., 39: 25S-28S, 1995.

21. Mays, D.C., Pawluk, L.J., Apseloff, G., Davis, W.B., She, Z., Sagone, A.L., and Gerber, N.: Metabolism of phenytoin and covalent binding of reactive intermediates in activated human neutrophils. Biochem. Pharmacol., 50:367-380, 1995.

22. Orosz, C.G., Wakely, E., Sergese, S.D., VanBuskirk, A.M., Ferguson, R.M., Mullet, D., Apseloff, G., and Gerber, N.: Prevention of murine cardiac allograft rejection with gallium nitrate: Comparison with anti-CD4 mAb. Transplantation, 61:783-791, 1996.

23. Apseloff, G., Swayne, J., and Gerber, N.: Medical histories may be unreliable in screening volunteers for clinical trials. Clin. Pharmacol. Ther., 60:353-356, 1996.

24. Apseloff, G., Foulds, G., LaBoy-Goral., L., Kraut, E., and Vincent, J.: Severe neutropenia caused by recommended prophylactic doses of rifabutin. Lancet, 348:685, 1996.

25. Apseloff, G., Foulds,G., LaBoy-Goral, L., and Vincent, J.: Severe neutropenia and prophylactic doses of rifabutin. Invited reply to a letter. Lancet, 348:1593, 1996..

26. Apseloff, G., Wilner, K.D., Gerber, N., and Tremaine, L.M.: Effect of sertraline on protein binding of warfarin. Clin. Pharmacokinet., 32:37-42, 1997.

27. Apseloff, G. Swayne, J., Gerber, N.: Reliability of screening procedures in identifying subjects suitable for enrollment in clinical pharmacology studies. Invited reply to a letter. Clin. Pharmacol. Ther., 62:113-114, 1997.

28. Apseloff, G., Hackshaw, K.V., Whitacre, C., Weisbrode, S.E. and Gerber, N.: Gallium nitrate suppresses lupus in MRL/lpr mice. Arch. Pharmacol., 356:517-525, 1997.

29. Apseloff, G., Foulds, G., LaBoy-Goral, L., Willavize, S., and Vincent J. Comparison of azithromycin and clarithromycin in their interactions with rifabutin in healthy volunteers. J. Clin. Pharmacol., 38:830-835, 1998.

30. Liston, T.E., Conklyn, M.J., Houser, J., Wilner, K.D., Johnson, A., Apseloff, G., Whitacre, C., and Showell, H.J.: Pharmacokinetics and pharmacodynamics of the leukotriene B4 receptor antagonist CP-105,696 in man following single oral administration. Br. J. Clin. Pharmacol., 45:115-121, 1998.

31. Foulds, G., LaBoy-Goral, L., Wei, G.C.G., and Apseloff, G.: The effect of azithromycin on the pharmacokinetics of indinavir. J. Clin. Pharmacol., 39:842-846, 1999.

32. Krecic-Shepard, M.E., Shepard, D.R., Mullet, D., Apseloff, G., Weissbrode, S.E., Gerber, N.: Gallium nitrate suppresses the production of nitric oxide and liver damage in a murine model of LPS-induced septic shock. Life Sci., 65:1359-1371, 1999.

33. Apseloff, G.: Therapeutic uses of gallium nitrate--past, present, and future. Am. J. Therap., 6:327-339, 1999

34. Apseloff, G., Mullet, D., Wilner, K.D., Anziano, R.J., Tensfeldt, T.G., Pelletier, S.M., Gerber, N.: The effects of ziprasidone on steady-state lithium levels and renal clearance of lithium. Br. J. Clin. Pharmacol., 49(S1): 61-64, 2000

35. Wilner, K. D., Demattos, S. B., Anziano, R.J., Apeloff, G., Gerber, N.: Ziprasidone and the activity of cytochrome P450 2D6 in healthy extensive metabolizers. Br. J. Clin. Pharmacol., 49(1): 43-47, 2000

36. Miceli, J.J., Wilner, K. D., Hansen, R. A., Johnson, A.C., Apseloff, G., Gerber, N.: Single- and multiple-dose pharmacokinetics of ziprasidone under non-fasting conditions in healthy male volunteers.  Br. J. Clin. Phamacol., 49(S1): 5-13, 2000

37. Apseloff, G., Xiaohui, B., LaBoy-Goral, L., Friedman, H., Shah, A.: Practical considerations regarding the influence of the menstrual cycle on leukocyte parameters in clinical trials.  Am. J. Therap., in press 2000.

38. Shah, A.K., LaBoy-Goral, L., Scott, N., Morse, T., Apseloff, G.: Pharmacokinetics and safety of oral eletriptan during different phases of the menstrual cycle in healthy volunteers. J. Clin. Pharmacol., 41:1339-1344, 2001.

39.    Gerber, N., Apseloff, G.: Fatality following an injection of Bicillin® into the tonsillar fossa during an adenotonsillectomy. Otolaryngol. Head Neck Surg., 126:321 2, 2002.

40. Tassava, R.A., Mendenhall, L., Apseloff, G., Gerber, N.: Gallium nitrate: effects on cartilage during limb regeneration in the axolotl, Ambystoma mexicanum. J.  Exp. Zool., 293:384 94, 2002.

41. Apseloff, G.: HIV testing in early clinical trials – who should decide whether it is warranted? J. Clin. Pharmacol., 42: 601-604, 2002.

42. Apseloff, G.: Severe neutropenia among healthy volunteers given rifabutin in clinical trials. Clin. Pharmacol. Ther., 74: 591 592, 2003.

43. Stoner, G.D.,  Sardo, D., Apseloff, G., Mullet, D., Wargo, W., Pound, V., Singh, A., Sanders, J., Aziz, R., Casto, B., Sun X.: Pharmacokinetics of anthocyanins and ellagic acid in healthy volunteers fed freeze-dried black raspberries daily for 7 days. J. Clin. Pharmacol., 45:1153-1164, 2005.

44. Shah, A., DeGroot, T., Apseloff, G.: Pharmacokinetic evaluation and safety profile of a 15-minute versus 30-second infusion of palonosetron in healthy subjects. J. Clin. Pharmacol., 46:1-7, 2006. 
ABSTRACTS

1. Shepard, D., Apseloff, G., Balboa, A., Mays, D., Gerber, N., Matkovic, V.: The effect of gallium nitrate on Paget's disease of bone. Pharmacologist, 31:161, 1989.

2. Matkovic, V., Apseloff, G., Mays, D., Balboa, A., Shepard, D., Gerber, N.: The effect of gallium nitrate on bone resorption indices in humans and bone mineral density in osteoporotic rat. Steenbock Symposium, 1989.

3. Matkovic, V., Apseloff, G., Mays, D., Balboa, A., Shepard, D., Gerber, N.: Plasma calcium and alkaline phosphatase activity in postmenopausal women treated with gallium nitrate. ASBMR/ICCRH First Joint Meeting, 1989.

4. Apseloff, G., Shepard, D., Chambers, M., Nawoot, S., Gerber, N., Mays, D.: Inhibition of theophylline metabolism by 8-methoxypsoralen: in vivo study in humans. Europ. J. Clin. Pharmacol., 36:263, 1989.

5. Pawluk, L., Mays, D., She, Z., Davis, W., Apseloff, G., Gerber, N.: Metabolism of phenytoin by activated human neutrophils. Europ. J. Clin. Pharmacol., 36:251, 1989.

6. Apseloff, G., Chambers, M., Shepard, D., Nawoot, S., Mays, D., Gerber, N.: Inhibition and induction of theophylline metabolism by 8-methoxypsoralen with resulting changes in its renal excretion: invivo study in the rat. FASEB J., 3:2948, 1989.

7. Matkovic, V., Apseloff, G., Balboa, A., Shepard, D., Pawluk, L., Mays, D., Gerber, N.: Gallium nitrate inhibits bone resorption in postmenopausal women. Pharmacologist, 31:160, 1989.

8. Apseloff, G., Shepard, D.R., Balboa, A., Gerber, N., Mays, D.C., Weisbrode, S.E., Stern, L.S., Matkovic, V.: The effect of gallium nitrate on osteopenia in rats and postmenopausal women. Europ. J. Pharmacol. 183: 1760-1761, 1990.

9. Apseloff, G., Mays, D., Pacula, C., Gerber, N.: Isolation of 5-methoxypsoralen from Earl Grey Tea. FASEB J. 4:A516, 1990.

10. Mays, D.C., Balboa, A., Pawluk, L.J., Nawoot, S., Apseloff, G., Gerber, N.: The rat is a useful model to study azidothymidine pharmacokinetics. Clin. Pharm. Ther. 147:157, 1990.

11. Wilner, K.D., Lazar, J.D., Apseloff, G., and Gerber, N: The effects of sertraline on the pharmacodynamics of warfarin in healthy volunteers. 5th World Congress of Biological Sciences, 1991.

12. Wilner, K.D., Lazar, J.D., von Deutsch, D.A., Apseloff, G., and Gerber, N.: The effects of sertraline on steady-state lithium levels and renal clearance of lithium. 5th World Congress of Biological Sciences, 1991.

13. Matkovic, V., Gerber, N., Brown, D., Apseloff, G., and Zwilling, B.S.: Differential effect of gallium on MHC class II expression by murine macrophages. FASEB J., 5:A1206, 1991.

14. Stern, L.S., Matkovic, V., Gerber, N., Apseloff, G., and Weisbrode, S.: Effects of gallium nitrate on osteopenia in rats. Bone & Min. Res., 6(1):S216, 1991.

 15. Apseloff, G., Girten, B., Weisbrode, S.E. Walker, M., Stern., L.S., Krecic, M.E.: Effects of Aminohydroxybutane bisphosphonate on bone in tail-suspended rats, FASEB J., 7:A150, 1993.

16. Apseloff, G., Whitacre, C., Weisbrode, S.E., Krecic, M.E., Shepard, D.R., Hackshaw, K., and Gerber, N.: Gallium suppresses lupus in MRL/lpr mice. ASCEPT, 1993.

17. Gerber, N. and Apseloff, G.: Immunomodulatory effects of gallium nitrate. Future Trends in Chemotherapy, Interdisciplinary World Congress on Antimicrobial and Anticancer Drugs, Palexpo Geneva, Switzerland, 1994.

18. Apseloff, G., Hackshaw, K., Whitacre, C., Weisbrode, S.E., and Gerber, N.: Gallium suppresses lupus in MRL/lpr mice. FASEB J., 8:A645, 1994.

 19. Koudriakova, T., Choe, S., Gerber, N., and G. Apseloff: Dose-dependent elimination of 5-methoxypsoralen: In vivo study in rats. FASEB J., 8:A99, 1994.

 20. Krecic, M.E., Mullet, D., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Zaveri, N., and Gerber, N.: Gallium nitrate attenuates lipopolysaccharide-induced hepatitis in Balb/c mice. ASCEPT, 1994.

21. Krecic, M.E., Shepard, D.R., Apseloff, G., Weisbrode, S.E., and Gerber, N.: Gallium nitrate attenuates lipopolysaccharide-induced hepatitis in Balb/c mice. FASEB J., 9:A944, 1995.

22. Collins, J., Choe, S., Spetie, D., Mullet, D., Koudriakova, T., Gerber, N., and Apseloff, G.: Lack of effect of cigarette smoking on the pharmacokinetics of rifabutin. FASEB J., 9:A688, 1995.

23. Koudriakova, T., Spetie, D., Utkin, I., Apseloff, G. and Gerber, N.: Pharmacokineticsof rifabutin in the rat. FASEB J., 9:A688, 1995.

24. Krecic, M.E., Mullet, D., Shepard, D.R., Apseloff, G., Weisbrode, S.E., Zaveri, N., and Gerber, N.: Gallium nitrate inhibits nitric oxide in vitro and attenuates lipopolysaccharide-induced hepatitis in Balb/c mice in vivo. Proceedings of 6th INWIN, Geneva, Switzerland, 1995.

25. Weisbrode, S.E., Apseloff, G., Hackshaw, K.V., Whitacre, C., and Gerber, N.: Gallium nitrate reduces lesions in MRL/lpr mice. 13th European Congress on Veternary Pathology, Edinburgh, Scotland, 1995.

 26. Weisbrode, S.E., Apseloff, G., Hackshaw, K.V., Whitacre, C., and Gerber, N.: Gallium nitrate ameliorates spontaneous lesions in MRL/lpr mice but induces osteosclerosis. 46th Annual Meeting, Bone & Joint Specialty Groups, Atlanta, GA, 1995.

27. Apseloff, G., LeRoy, B., Weisbrode, S.E., Collins, J., Gerber, N., and Mullet, D.: Gallium nitrate ameliorates asthma in B6D2F1/J mice. FASEB J., 10:A441, 1996.

28. Teng, R., Apseloff, G., Vincent, J., Pelletier, S.M., Willavize, S.A., and Friedman, H.L.: Effect of trovafloxacin (CP-99,219) on the pharmacokinetics and pharmacodynamics of warfarin in healthy male subjects. 36th ICAAC, 1996.

29. Vincent, J., Foulds, G., Apseloff, G., Laboy-Goral, L., Gerber, N.: Interaction of rifabutin (RIF) with the macrolides azithromycin (AZM) and clarithromycin (CLA). 36th ICAAC, 1996.

30. Foulds, G., LaBoy-Goral, L., Wei, G., Apseloff, G.: The effect of azithromycin (AZM) on the pharmacokinetics of indinavir (IND). Fourth International Conference on the Macrolides, Azalides, Streptogramins & Ketolides. Barcelona, Spain. Abstract #5.04, p. 53, 1998.

31. Vincent, J., Gardner, M.J., Apseloff, G., Baris, B., Willavize, S., Friedman, H.L.: Cimetidine inhibits renal elimination of dofetilide without altering QTc activity on multiple dosing in healthy subjects. Clin. Pharmacol. Therap. 63: 210, 1998.

32. Vincent, J., Agin, M., LaBoy-Goral, L., Hunt, T., Carlson, J., Apseloff, G., Kuye, O.: The effect of dosing with food and bedtime dosing on the incidence of dizziness with trovafloxacin in young, healthy, female subjects. 38th ICAAC, 1998.

33. Shah, A.K., Friedman, D.L., Morse, T.M., LaBoy-Goral, L., Hinkel, C.A., Silber, M., Apseloff, G., Friedman, H.L.: Evaluation of methods for rapid screening of CYP2D6 status using dextromethorphan as a probe in normal, healthy subjects. aaps PharmSci Suppl, 1(1):S-32, 1998.

34. Apseloff, G., Vashi, V., Kuye, O.: Lack of a pharmacokinetic interaction between amlodipine and atorvastatin at steady-state. aaps PharmSci Suppl, 1(1):S-623, 1998.  

35. Sardo, C., Sun, X, Apseloff, G., Mullet, D., Wargo, W., Pound, V., Singh, A., Sanders, J., Aziz, R., Casto, B., Stoner, G.:  Pharmacokinetics of anthocyanins and ellagic acid in healthy subjects consuming black raspberries. Cancer Epidemiology Biomarkers and Prevention, 13(11): Part 2, 1882S, 2004.

36. Jones, T., Apseloff, G., Carter, E.: Comparative pharmacokinetics of topical tacrolimus cream 0.03% with cream 0.01% and ointment 0.03% in adults and with ointment 0.03% in pediatric patients with atopic dermatitis. J. Am. Acad. Derm. 52(3):68, 2005.

37. Singh, A., Apseloff, G., Colucci, R., Harris S.C., Vashi, V.: A crossover study with single & divided-dose oral naloxone (NX), oral pentazocine/NX, & intravenous NX in healthy subjects. Clin. Pharmacol. Therap., 77(2): P85, 2005.

38. Apseloff, G., Singh, A., Vause E., Richards P.: Determination of the optimal configuration of ALGRX 3268 for induction of local analgesia prior to venipuncture in the antecubital fossa. J. Pain, 6(3):S50, 2005.

39. Apseloff, G., Vause E., Singh, A., Sykes, D.: Treatment with ALGRX 3268 does not result in detectable lidocaine levels in healthy adults. J. Pain, 6(3):S49, 2005.

40. Apseloff, G., Gallagher, S., Shah, A.: Pharmacokinetics (PK) and safety evaluation of palonosetron (PALO) administered as a 15-minute infusion versus a 30-second infusion in healthy subjects. Support. Care Cancer, 13:412-413, 2005.

41. Strout, V., Casey, L., Nardone, L., Curtis, K., Adaelu, J., D’Alia, G., Lazar, J., Singh, A., Apseloff, G.: ETI-204, a monoclonal antibody with high affinity against protective antigen produced by anthrax, is well tolerated and safe when administered alone or with ciprofloxacin in healthy volunteers. 46th ICAAC Abstract Book,  p. 41, 2006.

SELECTED GRANTS FROM INDUSTRIAL SPONSORS

1. Phase I Study to Determine the Difference Between Urine Concentrations of CP-73-850 at Steady State and the Urine Solubility of CP-73,850 in Healthy Volunteers (078-007-501), 1988. Pfizer, Inc. Co-Investigator.

2. Disopyramide Bioavailability Pilot Study Protocol Kinaform, 1988. Chartwell Technologies Inc. Co-Investigator.

3. Pilot Study to Assess the Reproducibility of Steady State Serum Lithium Concentrations and Renal Clearance of Lithium in Healthy Volunteers (050-015-501), 1988. Pfizer, Inc. Co-Investigator.

4. Phase I Study of the Effect of Concomitant Antacid Administration on the Absorption of Azithromycin (066-015-501), 1988. Pfizer, Inc. Co-Investigator.

5. A Multiple Dose, Double-Blind, Placebo-Controlled Study of the Safety, Toleration and Pharmacokinetics of CP-72,467 in Healthy Male Volunteers (118-001-501), 1988. Pfizer, Inc. Co-Investigator.

6. Phase I Study to Assess the Potential of Amlodipine to Alter the Pharmacodynamics of Warfarin (053-011-501), 1988. Pfizer, Inc. Co-Investigator.

7. Phase I Study to Assess the Potential of Sertraline to Alter Steady State Serum Lithium Levels and Renal Clearance of Lithium in Healthy Volunteers (050-017-501), 1988. Pfizer, Inc. Co-Investigator.

8. Phase I Study of the Effect of Concomitant Cimetidine Administration on the Absorption of Azithromycin (066-016-501), 1988. Pfizer, Inc. Co-Investigator.

9. Evaluation of the Safety, Clinical Activity, Toleration and Pharmacokinetics of CP-80,794. A Single Escalating Dose Study in Normotensive Healthy Volunteers (120-001-501), 1988. Pfizer, Inc. Co-Investigator.

10. A Phase I Study in Normal Male Volunteers to Assess the Safety, Toleration and Pharmacokinetics of CP-72,133-2 (110-001-501), 1988-1989. Pfizer, Inc. Co-Investigator.

11. An Ultrasound Study of Ovarian Cyst Activity Comparing CTR-04 and CTR-05 Versus a Concurrent Untreated Control (013-010), 1989 - 1990. Organon. Principal Investigator.

12. Phase I Study of the Safety, Toleration, and Bioavailability of Two Topical Piroxicam Formulations in Healthy Volunteers (020-001-501), 1989. Pfizer, Inc. Co-Investigator.

13. CGS-13492A Single-Oral-Dose Safety Study in Volunteers, Protocol 01, Version 2, 1989. Ciba-Geigy. Co-Investigator.

14. Phase I Study of the Effect of Concomitant Rifampin Therapy on the Disposition of Fluconazole (056-008-501), 1989. Pfizer, Inc. Co-Investigator.

15. Test of the Absorption of Adria Magnesium Lactate Tablets (114002-000), 1989. Adria Laboratories. Co-Investigator.

16. Phase I, Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Pharmacokinetics of CP-80,794 in Normotensive Male Volunteers (120-003-501), 1989. Pfizer, Inc. Co-Investigator.

17. Phase I Study to Assess the Safety, Toleration and Bioavailability of Topically Applied CP-70,490-09 (124-002-501), 1989. Pfizer, Inc. Co-Investigator.

18. A Bioavailability Study of Three Formulations of CP-72,133 (110-003-501), 1989. Pfizer, Inc. Co-Investigator.

19. Phase I Study to Assess the Potential of Tenidap Sodium to Alter Steady State Serum Lithium Levels and Renal Clearance of Lithium in Healthy Volunteers (064-017-501), 1989. Pfizer, Inc. Co-Investigator.

20. Phase I Study to Assess the Potential of Tenidap Sodium to Alter the Pharmacodynamics and Plasma Protein Binding of Warfarin in Healthy Volunteers (064-018-501), 1989. Pfizer, Inc. Co-Investigator.

21. Single Dose Pharmacokinetic and Bioavailability Study of Toremifene in Postmenopausal Healthy Volunteers (092016-000), 1989 - 1991. Adria Laboratories. Co-Investigator.

22. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and Pharmacokinetics of Oral CP-72,133 in Normal Male Volunteers (110-002-501), 1989. Pfizer, Inc. Co-Investigator.

23. Single Oral Dose Safety Study of CGS-13429A in Volunteers (amended), 1989. Ciba-Geigy. Co-Investigator.

24. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Pharmacokinetics of Topically Applied CP-70,490-09 in Normal Male Volunteers (120-004-501), 1989. Pfizer, Inc. Co-Investigator.

25. Relative Bioavailability and Dose Proportionality of CGS-13429A Following Single Doses of 4.0 mg Oral Buffered Solution, Two 2.0 mg Tablets and 4.0 mg Duodenal Infusion in the Fasted State and Two 20.0 mg Tablets Non-Fasted in Healthy Volunteers (Protocol 02), 1989. Ciba-Geigy. Co-Investigator.

26. Phase I Study to Assess the Potential of Sertraline to Alter the Pharmacodynamics and Plasma Protein Binding of Warfarin in Healthy Male Volunteers (050-018-501), 1989. Pfizer, Inc. Co-Investigator.

27. Open Label Crossover Study of the Uricosuric Activity of Single Doses of Tenidap Sodium (CP-66,248-2) Compared to Probenecid (064-025-501), 1989. Pfizer, Inc. Co-Investigator.

28. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and Pharmacokinetics of Oral CP-72,133 in Normal Male Volunteers (110-002-501). Rechallenge. 1989. Pfizer, Inc. Co-Investigator.

29. Phase I Study of the Effect of Concomitant Antacid Administration on the Absorption of Amlodipine (053-012-501), 1990. Pfizer, Inc. Co-Investigator.

30. Single Dose Study of CP-86,325-2 in Normal Healthy Male Volunteers (127-001-501), 1990. Pfizer, Inc. Co-Investigator.

31. Multiple Oral Dose Safety Study of CGS-15873A in Healthy Normal Male Volunteers (06), 1990. Ciba-Geigy. Co-Investigator.

32. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and Pharmacokinetics of CP-88,059-1 Following Escalating Single Oral Doses in Healthy Male Volunteers (128-001-501), 1990. Pfizer, Inc. (Section 1). Co-Investigator.

33. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and Pharmacokinetics of Oral CP-86,325-2 in Normal Male Volunteers (127-002-501), 1990. Pfizer, Inc. Co-Investigator.

34. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Pharmacokinetics of Oral CP-88,059-1 in Normal Male Volunteers (128-002-501), 1990. Pfizer, Inc. Co-Investigator.

35. Multiple Oral Dose Safety Study of CGS-18102A in Healthy Normal Male Volunteers (02), 1990. Ciba-Geigy. Co-Investigator.

36. A Continued Assessment of the Safety, Tolerance, and Pharmacokinetics of Single Intravenous Doses of ADR-851 Compared to Placebo in Normal Healthy Male Volunteers (117003-000), 1990. Adria Laboratories. Principal Investigator.

37. Double-Blind, Multiple Dose, Dose Escalating Safety Study of Intravenous RG 12915 in Normal Volunteers, 1990. Rorer Central Research. Principal Investigator.

38. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Pharmacokinetics of Oral CP-88,059-1 Titrated from 20 Mg, BID to Either 60 Mg, BID or 80 Mg, BID in Normal Male Volunteers (128-005-501), 1991. Pfizer, Inc. Co-Investigator.

39. Phase I Double-Blind Evaluation of the Biological Effects and Safety of Multiple Doses of CP-74,639 in Normal Subjects (090-003-501), 1991. Pfizer, Inc. Co-Investigator.

40. Phase I Crossover Study to Compare the Uricosuric Activity of a Single Dose of Sertraline with that of Probenecid (050-023-501), 1991. Pfizer, Inc. Co-Investigator.

41. Phase I Double-Blind Evaluation, Placebo-Controlled Evaluation of the Safety, Toleration and Pharmacokinetics of CP-108,671 Following Escalating Single Oral Doses in Normotensive Male Volunteers (147-001-501), 1991. Pfizer, Inc. Co-Investigation.

42. Phase I Study to Determine the Levels of Tenidap Excreted in Breast Milk Compared with the Plasma Levels of Tenidap in Normal Healthy Nursing Women (064-020-501), 1992. Pfizer, Inc. Co-Investigator.

43. Phase I Multiple Dose, Double-Blind, Placebo-Controlled, Study Evaluating the Safety and Pharmacokinetics of Oral CP-86,325-2 at Doses of 50 to 200 mg/day in Normal Male Volunteers (127-003-501), 1992. Pfizer, Inc. Principal Investigator.
44. Phase I Study to Examine the Metabolism and Excretion of 14C-Tenidap in Patients with Biliary T-Tube Drainage (064-047-504), 1992. Pfizer, Inc. Principal Investigator.

45. Phase I Multiple Dose, Single-Blind Study to Assess the Effect of Tenidap on Platelet Aggregation and Serotonin Release in Normal, Healthy Male Volunteers Ex Vivo (064-050-504), 1992. Pfizer, Inc. Principal Investigator.

46. Phase I Single Dose, Double-Blind, Placebo-Controlled, Study Comparing the Safety and Pharmacokinetics of Oral CP-86,325 to its Metabolite, CP-95,637 in Normal Male Volunteers (127-004-501), 1992. Pfizer, Inc. Principal Investigator.

47. Double-Blind Evaluation of the Safety and Pharmacokinetics of Single Ascending Intravenous Doses of FK-037 (RWJ 45914-144) in Normal Subjects (M92-001), 1992. R.W. Johnson. Principal Investigator.

48. Phase I Study of the Pharmacokinetics and Tolerability of Escalating Single Oral Doses of SC-49483 in HIV-1 (+) Volunteers with > 300 CD4+ Cells/mm3 (NQ3-92-02-101), 1992. G.D. Searle. Principal Investigator.

49. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration and Pharmacokinetics of CP-105,696 Following Escalating Single Oral Doses in Normal Male Volunteers (158-001-501), 1992. Pfizer, Inc. Principal Investigator.

50. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Pharmacokinetics of Oral CP-88,059-1 Under Non-Fasting Conditions in Normal Male Volunteers (128-013-501), 1992. Pfizer, Inc. Principal Investigator.

51. A Pilot Study to Assess the Oral Absorption Profile of Azithromycin in Ileostomy Patients (066-049-501), 1992. Pfizer, Inc. Principal Investigator.

52. A Double-Blind, Randomized, Placebo Controlled, Dose Escalating, Crossover Study to Evaluate Safety, Tolerability and Delivery Rates of Sandostatin? via Iontophoresis in Healthy Male Volunteers (Z101), 1993. Sandoz Pharmaceuticals Corporation. Principal Investigator.

53. Phase I Multiple Dose Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration and Pharmacokinetics of CP-105,696 in Normal Male Volunteers (158-002-501). 1993. Pfizer, Inc. Principal Investigator.

54. An Observer-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Cimetidine on the Pharmacokinetics and Pharmacodynamics of Dofetilide After Multiple Dosing (115-004-501), 1993. Pfizer, Inc. Principal Investigator.

55. An Open-Label, Single Dose, Crossover Study in Adult, Male Volunteers to Evaluate the Effect of Food on Bioavailability of SDZWAG994 (P103), 1993. Sandoz Pharmaceuticals Corporation. Principal Investigator.

56. Phase I Double Blind, Placebo Controlled, Study of the Safety, Toleration and Pharmacokinetics of CP-114,271 When Administered as Escalating Single Doses to Moderately Obese Volunteers (151-001-501), 1993. Pfizer, Inc. Principal Investigator.

57. A Two-Phase, Double-Blind, Placebo Controlled, Study in Adult Male Volunteers to Evaluate the Interaction of Digoxin and SDZ WAG 994 (P109), 1993. Sandoz Pharmaceuticals Incorporation. Principal Investigator.

58. Phase I Multiple Dose, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Pharmacokinetics of Oral CP-88,059-1 Under Non-Fasting Conditions in Normal Male Volunteers (128-013-501), 1993. Pfizer, Inc. Principal Investigator.

59. A Multiple-Dose Evaluation of the Contribution of the Antihistamine Component of Regular Dristan? Nasal Spray to the Symptomatic Relief of Nasal Congestion Associated with Upper Respiratory Tract Infections (WM-600), 1993-1995. Whitehall/Kendle Research Associates. Co-Investigator.

60. Phase I, Double Blind, Placebo Controlled, Study of the Safety, Toleration, Pharmacokinetics and Pharmacodynamics of CP-114,271 When Administered as Escalating Multiple Doses to Moderately Obese Volunteers (151-002-501), 1993. Pfizer, Inc. Principal Investigator.

61. Phase I Open Pilot Study to Compare the Pharmacokinetics of a Single 80 mg Oral Dose of CP-88,059-1 Administered as Four 20 mg Capsules and One 80 mg Capsule to Normal, Healthy Male Volunteers (128-019-501), 1993. Pfizer, Inc. Principal Investigator.

62. An Open Label Study of OG 37-325 in Stable Renal Transplant Patients to Evaluate the effect of Concomitant Administration of a Single Dose of Erythromycin Ethylsuccinate (EES) on the Pharmacokinetic Profile of OG 37-325 (P335), 1994. Sandoz Pharmaceuticals Incorporation. Principal Investigator.

63. Experiments Involving Endotoxin-Mediated Hepatitis and Endotoxic Shock in Mice and other Species, 1994. Ben Venue Laboratories. Co-Investigator.

64. An Open-Label Study in Healthy Volunteers to Evaluate the Absorption of SDZ WAG 994 from the Small and Large Intestine (P121), 1994. Sandoz Pharmaceuticals Incorporation. Principal Investigator.

65. Phase I Double-Blind, Placebo Controlled, Evaluation of Safety, Toleration, and Pharmacokinetics of CJ-11,802 Following Escalating Single Oral Doses in Healthy Male Volunteers (177-001-501), 1994. Pfizer, Inc. Principal Investigator.

66. Phase I Comparative Study of the Clinical Pharmacology of Azithromycin High Dosage Strength Tablets After Fed and Fasted States in HIV-Infected Male Subjects (066-061-501), 1994. Pfizer, Inc. Co-Investigator.

67. Phase I Open Study to Assess the Potential of Ziprasidone to Alter the Renal Clearance of Lithium and Steady-State Serum Lithium Levels in Normal, Healthy Male Volunteers (128-025-501), 1994. Pfizer, Inc. Co-Investigator.

68. Phase I, Double-Blind, Placebo-Controlled, Crossover Evaluation of the Effects of CJ-11,974 on the Hypoxic Ventilatory Drive and the Perception of Dyspnea in Healthy Male Subjects (167-005-4005), 1994. Pfizer, Inc. Co-Investigator.

69. Open Study Performed in a Parallel Group Design to Investigate the Effect of Age on the Pharmacokinetics of Monatepil in 15 Elderly and 15 Young Volunteers Matched for Body Surface (DA285), 1994-1995. LAB. Co-Investigator.

70. Phase I Double-Blind, Parallel, Placebo Controlled Pilot Study to Assess the Safety, Toleration and Pharmacokinetics of Oral Sertraline Administered as a Single Dose and Over a Defined Period of Time to Normal, Healthy Male Volunteers (050-031-501), 1995. Pfizer, Inc. Principal Investigator.

71. Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Six Weeks Treatment with Oral CJ-11,974 in Adults with Mild to Moderate Asthma (167-102-4005), 1995. Pfizer, Inc. Co-Investigator.

72. Phase I, Open Study to Assess the Potential of Zopolrestat to Alter the Pharmacodynamics and Plasma Protein Binding of Warfarin in Normal, Healthy Male Volunteers (078-014-501), 1994. Pfizer, Inc. Co-Investigator.

73. A Placebo-Controlled Study to Compare the Gastrointestinal Effects of Different Formulations of Azithromycin When Given as a Single Oral Dose to Parallel Groups of Healthy Volunteers (066-072), 1995. Pfizer, Inc. Co-Investigator.

74. Phase I Double-Blind, Placebo-Controlled, Study of the Clinical Pharmacology of Multiple Doses of CP-143,867 in Healthy Male Subjects (175-006), 1995. Pfizer, Inc. Co-Investigator.

75. Phase I Open Pilot Study to Compare the Pharmacokinetics of Ziprasidone Administered as 2 X 20 mg Research Capsules and as a 40 mg Proposed Commercial Suspension in Normal Healthy Subjects (128-034-501), 1995. Pfizer, Inc. Principal Investigator.

76. Phase I Study to Evaluate the Pharmacokinetic Interaction Between Rifabutin and the Macrolides Azithromycin and Clarithromycin in Healthy Subjects (066-074-501), 1995. Pfizer, Inc. Principal Investigator.

77. The Effect of Trovafloxacin on the Pharmacodynamics of Warfarin in Healthy Male Subjects (154-034-501), 1995. Pfizer, Inc. Principal Investigator.

78. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 300 Mg Oral Dose of CP-195,543 Administered as a Capsule Under Fasting and Fed Conditions and as a Suspension Under Fasting Conditions in Healthy Volunteers (207-003-501), 1995. Pfizer, Inc. Principal Investigator.

79. Phase I Open Study to Evaluate Renal Function in Normal, Healthy Male Volunteers (064-408-501), 1995. Pfizer, Inc. Principal Investigator.

80. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and Pharmacokinetics of CJ-12,255 Following Escalating Single Oral Doses in Healthy Male Subjects (219-001), 1995. Pfizer, Inc. Principal Investigator.

81. Phase I Double-Blind, Parallel, Placebo-Controlled Pilot Study to Assess the Safety, Toleration and Pharmacokinetics of Oral Sertraline Administered as a Single Dose and Over a Defined Period of Time to Normal, Healthy Male or Female Volunteers, Part II (050-032), 1995. Pfizer, Inc. Principal Investigator.

82. Evaluation of Methods for Rapid Screening of Polymorphic Metabolism Status Using Dextromethorphan as a Probe in Normal, Healthy Subjects (161-402-9501), 1996. Pfizer, Inc. Principal Investigator.

83. Phase I Open Study to Assess the Potential of a CYP 2D6 Interaction of Ziprasidone Using Dextromethorphan in Normal, Healthy Subjects (128-048-501), 1996. Pfizer, Inc. Co-Investigator.

84. Phase I Open Crossover Study of the Relative Bioavailability of CJ-12,255 Administered as a Solution in the Fasted and Postprandial States (219-002-9501), 1996. Pfizer, Inc. Principal Investigator.

85. Phase I Study to Determine the Excretion into Breast Milk and Pharmacokinetics After Single Oral Dose Administration of Eletriptan in Normal, Healthy Nursing Women (160-003-9501), 1996. Pfizer, Inc. Principal Investigator.

86. A Study to Assess the Effect of a Single 1200 mg Dose of Azithromycin on the Pharmacokinetics of Indinavir (066-085-9501), 1996. Pfizer, Inc. Principal Investigator.

87. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 100 mg Oral Dose of CP-88,144 Administered as a Capsule Under Fasting and Fed Conditions to Healthy Volunteers (225-003-9501), 1996. Pfizer, Inc. Principal Investigator.

88. Phase I Study to Determine the Influence of Different Phases of the Menstrual Cycle on the Pharmacokinetics After Single Oral Dose Administration of Eletriptan in Normal, Healthy Female Subjects (160-004-9501), 1997. Pfizer, Inc. Principal Investigator.

89. The Effect of Amlodipine on the Pharmacokinetics of Atorvastatin in Healthy Male Subjects (053-019-80B), 1997. Pfizer, Inc. Principal Investigator.

90. Phase I Open Study to Compare the Bioavailability of Pseudoephedrine Administered as an asymmetric membrane technology (AMT) tablet versus Efidac/24? After Single Dose Administration to Normal Healthy Subjects (S/B 97Ck16-0705/97-N-001 and 143-002-9501), 1997. Pfizer, Inc. Principal Investigator.

91. Phase I Pilot Open Study to Compare the Pharmacokinetics of a Single 10 mg Oral Dose of CP-361,428 Administered as a Tablet Under Fasting and Fed Conditions to Healthy Volunteers (245-003-501), 1997. Pfizer, Inc. Principal Investigator.

92. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, and Pharmacokinetics of CP-409,092 Following Escalating Single Oral Doses in Healthy Male Subjects (270-001-9501), 1997. Pfizer, Inc. Principal Investigator.

93. Evaluation of the Efficacy of Gallium Nitrate in the Treatment of Sarcoidosis, 1997. Ben Venue Laboratories. Principal Investigator.

94. An Open-label, Multiple Dose, Two-way Crossover Comparison of Efidac/24® versus Sudafed® in Healthy Subjects (143-401-9501), 1997. Pfizer, Inc. Principal Investigator.

95. Escalating, Single Dose, Placebo-Controlled, Double-Blind, Randomized, Safety, Toleration, Pharmacokinetic and Pharmacodynamic Study of CP-368,296 Administered orally to Normal, Healthy Subjects and Non-Insulin Dependent Diabetic Subjects (263-001-9501). 1997. Pfizer, Inc. Principal Investigator.

96. Phase I Study to Determine the Influence of Different Phases of the Menstrual Cycle on Leukocyte Counts and Leukocyte Profiles, 1997. Pfizer, Inc. Principal Investigator.

97. The Effect of Food and Time of Drug Administration in the Safety and Toleration of Trovafloxacin in Young Female Subjects (154-055-9501), 1997. Pfizer, Inc. Principal Investigator.

98. Phase I Study to Examine the Serum Concentrations of CP-66,458 Following Administration of Azithromycin as Capsules and Tablets in the Fasted and Fed States (066-093-9501), 1997. Pfizer, Inc. Principal Investigator.

99. Phase I Double-Blind, Placebo-Controlled Evaluation of the Safety, Toleration, Pharmacokinetics of CJ-11,974 in Healthy, Elderly Volunteers (167-007-9501), 1997. Pfizer, Inc. Principal Investigator.

100. Phase I Double-Blind, Placebo-Controlled Study of the Clinical Pharmacology of CP-409,092 Following Multiple Dosing in Healthy Male Subjects (270-003-9501), 1997-8. Pfizer, Inc. Principal Investigator.

101. An Open, 3-Way Single Dose, Crossover Study to Determine the Pharmacokinetics of CP-409,092 under Fasting and Fed Conditions in Healthy Male Subjects (270-002-9501), 1998. Pfizer, Inc. Principal Investigator.

102. Phase I Open Pilot Evaluation of the Effect of Food on the Bioavailability of a Controlled Release CP-409,092 Dosage Form Relative to a Fasting Solution Dose in Healthy Male Subjects (270-006-9501), 1998. Pfizer, Inc. Principal Investigator.

103. Phase I Open Pilot Evaluation of the Bioavailability of Two Controlled Release CP-409,092 Dosage Forms Relative to a Solution Dose in Healthy Male Subjects (270-007-9501), 1998. Pfizer, Inc. Principal Investigator.

104. Phase I Study of the Clinical Pharmacology of CP-409,092 Following Multiple Dosing in Healthy Male Subjects Previously Exposed to CP-409,092 (270-010-9501), pending 2000. Pfizer, Inc. Principal Investigator.

105. Evaluation of Potential Effects of 20-mg V20001 on Urinary Excretion Ratio of 6-ß -Hydroxycortisol to Cortisol in Patients with Type 2 Diabetes Mellitus (KD98-1001), 1999. Purdue Pharma L.P. Principal Investigator.

106. An Open-Label Study to Determine the Apparent Time to Steady-State Plasma Concentrations Following the Application of Buprenorphine Transdermal System (BTDS) and the Effects of Local Heat on the Plasma Concentrations of Buprenorphine After BTDS Removal (BP99-0204), 1999. Purdue Pharma L.P.  Principal Investigator.

107. An Open-Label Study in Normal Subjects and Subjects Without Gallbladders to Determine Whether Hydromorphone Undergoes Enterohepatic Recirculation (HD98-0504), 1999. Purdue Pharma L.P. Principal Investigator.

108. A Single-Dose, Open-Label, Randomized, Three-Period, Six-Sequence, Three-Treatment Crossover Study Comparing Controlled and Immediate-Release Hydrocodone Tablets and Assessing the Effect of Food on Controlled-Release Hydrocodone Tablets (HCD-1001), 1999. Purdue Pharma L.P.  Principal Investigator.

109. Phase II, Double-Blind and Placebo-Controlled  Methodology Study to Assess the Effect of Immediate-Release Paroxetine and Sertraline Using a Controlled-Release Formulation Prototype on Sexual Function (A0501025), 2000. Pizer, Inc. Principal Investigator.

110.  A Double-Blind, Placebo Controlled, Escalating Single Dose Study of the Safety, Tolerability and Pharmacokinetics of V102862 in Healthy Volunteers (CSC-1001), 2000. Purdue Pharma L.P.  Principal Investigator.

111. Phase II, Double-Blind and Placebo-Controlled Methodology Study to Assess the Effect of Immediate-Release Paroxetine and Sertraline Using a Controlled-Release Formulation Prototype on Sexual Function (A0501025), 2000. Pfizer, Inc.  Principal Investigator.

112.  A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods in Healthy Subjects (BUP1002), 2000.  Purdue Pharma L.P.  Principal Investigator.

113.  Phase II, Double-Blind and Placebo-Controlled Study to Assess the Effect of CP-122,721 on Sexual Function (CP-122,721), 2000. Pfizer, Inc.  Principal Investigator.

114.  A Four-Way Open-Label, Randomized Crossover Study with Talwin7 Nx, Single-Dose Oral Naloxone, Divided-Dose Oral Naloxone, and Intravenous Naloxone in Healthy Subjects, 2001. Purdue Pharma, L.P.  Principal Investigator.

115.  A Double-Blind Placebo-Controlled, Parallel Group Design Dose-Ranging Study of Three Doses of Lasofoxifene vs. Placebo for the Treatment of Sexual Dysfunction (Arousal Disorder) in Postmenopausal Women (A2181015), 2002. Pfizer, Inc. Principal Investigator.

116.  A Double-Blind Placebo-Controlled, Parallel Group Design Dose-Ranging Study of Three Doses of Lasofoxifene vs. Placebo for the Treatment of Sexual Dysfunction (Hypoactive Desire) in Postmenopausal Women (A2181021), 2002. Pfizer, Inc.  Principal Investigator.

117.  A Study of the Safety and Efficacy of Lasofoxifene in the Treatment of Vaginal Atrophy in Postmenopausal Women (A2181012), 2002. Pfizer, Inc. Principal Investigator.

118.    Collection of Human Plasma from Healthy Volunteers Following a High-Fat Meal and Human Serum from Capillary Blood Obtained via Finger Sticks (OXU9002), 2002.  Purdue Pharma L.P.  Principal Investigator.

119.  A Phase 1, Single-Center, Open-Label, Study to Evaluate The Effect of Multiple Intravenous Doses of Repifermin on Proliferation and Thickening of the Oral Mucosa and Whole Saliva Production in Healthy Subjects (KGF-2-M10), 2002. Human Genome Sciences, Inc.  Principal Investigator.

120.  Tolerability of Oral Naltrexone in Patients Receiving OxyContin.(OCX1001), 2002. Purdue Pharma, L.P.  Principal Investigator.

121.  Study to Determine the Stability of Drugs in Clotted Blood from Healthy Volunteers (OXP9001), 2002. Purdue Pharma, L.P.  Principal Investigator.

122.  Phase I Study to Determine the Optimal Configuration of ALGRX 3268 (3268-1-100-001), 2002.  AlgoRx Pharmaceuticals. Principal Investigator.

123.  Tacrolimus Pharmacokinetics in Adult Atopic Dermatitis Patients After Topical Administration of Tacrolimus Cream 0.01% and 0.03% and Protopic® (Tacrolimus) ointment 0.03% (01-0-127), 2002.  Fujisawa Healthcare, Inc. Principal Investigator.

124.  Tacrolimus Pharmacokinetics In Adult Psoriasis Patients After Topical Administration Of Tacrolimus Cream 0.1% and 0.5% (02-0-139), 2002.  Fujisawa Healthcare, Inc. Principal Investigator.

125.  Phase I Study To Quantitate Systemic Lidocaine Exposure after Treatment with ALGRX 3268 (3268-1-101-001), 2002. AlgoRx Pharmaceuticals. Principal Investigator.

126.  A Longitudinal Population-Based Study of Peripheral Blood Gene Expression Profiles in Healthy Volunteers (9999A1-900-WW), 2003. Wyeth Research. Principal Investigator.

127.  A Phase 1 Study to Evaluate the Safety and Tolerability of Hydrocodone/Naltrexone/ Acetaminophen (HXA) Combination Tablet in Healthy Subjects (HXA1017), 2003.  Purdue Pharma, L.P. Principal Investigator.

128.  Phase I Study to Determine the Optimal Configuration of ALGRX 3268 for the Back of the Hand (3268-1-102-001), 2003.  AlgoRx Pharmaceuticals. Principal Investigator.

129.  A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a V134444 Oral Suspension Following AM Administration in Healthy Male Adults (CSH1001), 2003.  Purdue Pharma, L.P. Principal Investigator.

130.  An Exploratory Pharmacogenomic Study of Estrogen-Regulated Genes in the Human Vagina of Postmenopausal Women with Vaginal Atrophy Treated with 17β-estradiol (9800R1-900-US), 2004.  Wyeth Research.  Principal Investigator.

131.  A Single-center, Open-label, Randomized Investigation in Healthy Volunteers to Determine the Intranasal Bioavailability of Naltrexone in a Three-way Crossover Study (OCX1009), 2004.  Purdue Pharma, L.P.  Principal Investigator.

132.  A Single-Center, Open-Label, Randomized Investigation in Healthy Volunteers to Determine the Intranasal and Sublingual Bioavailabilities of Naloxone in a Four-way Crossover Study (OXN1001), 2004.  Purdue Pharma, L.P.  Principal Investigator.

133.  A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a V112054 Liquid Oral Formulation Following in Healthy Male Adults (CSB1001), 2004.  Purdue Pharma, L.P.  Principal Investigator.

134.  An Open-Label, Nonrandomized, 2-Period, Fixed Sequence Study to Investigate the Effect of Single and Repeat Oral Doses of Esomeprazole on the Single-Dose Pharmacokinetics of AVANDAMET XR (2 tablets of the DiffCORE combination formulation of rosiglitazone 4mg/metformin 1000 mg) in Healthy Volunteers (SB-712753/901), 2004.  GlaxoSmithKline. Principal Investigator.

135. A Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Tolerability of a Single Subfascial/Intramuscular Injection of ALGRX 4975 in Healthy Male Subjects (4975-1-009-1), 2005. AlgoRx Pharmaceuticals. Principal Investigator.

136. A Randomized Placebo-Controlled Crossover Trial Evaluating the Effect of Naltrexone at 1, 3, and 6 mg Dose Levels on the Abuse Potential of 40 mg Oxycodone in Non-dependent, Opioid-preferring Subjects (OCX2002), 2005.  Purdue Pharma, L.P.  Principal Investigator.

137. Phase I, Open-label, Randomized, Two-way Crossover Study in Healthy Subjects to Determine the Pharmacokinetics and Safety of Aloxi® (Palonosetron HCL I.V.) When Administered as a 15-minute Infusion Compared to a 30-second Infusion (PALO-04-21), 2005, MGI Pharma, Inc.  Principal Investigator.

138. An Open-Label Study to Determine the Sound Emission Levels Produced by a Needle-Free Injector for Medical Use (ALGRX 3268 ND5.3A) in Healthy Adult Volunteers  (3268-1-005-1), 2005. AlgoRx Pharmaceuticals.  Principal Investigator.

139. A 4-Period, Single Ascending Dose, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics in Healthy Postmenopausal Women of Oral GSK232802, Followed by Staggered Parallel Group, Randomized, Placebo-Controlled Once Daily Repeated Oral Doses for 4 Weeks (SRM19011), 2005. GlaxoSmithKline.  Principal Investigator.

140. A Randomized, Open-Label, Single-Dose, 14-Treatment, 4-Period, Incomplete Block, Cross Over Pilot Study in Healthy Male and Female Subjects to Assess the Pharmacokinetic Characteristics and Relative Bioavailability of Hydromorphone Following Administration of 3 New Palladone Melt Extrusion Multiparticulate Formulations (12 mg) in the Fed and Fasted State, With and Without Concomitant Ethanol Administration (HMP1015), 2005. Purdue Pharma L.P.  Principal Investigator.

141. Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Phase I Study of the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Dose of ETI-204 (AnthimTM) and its Potential Interaction with Ciprofloxacin (AH-101), 2005-2006. Elusys Pharmaceuticals.  Principal Investigator.

142. Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NRI-022 Administered Orally to Healthy Postmenopausal Women (3190A1-100-US), 2006. Wyeth Research.  Principal Investigator.

143. A Randomized, Open-Label, Single-Dose, Four-Way Crossover Pilot Study in Healthy Subjects to Assess the Pharmacokinetic Characteristics and Relative Bioavailability of Hydromorphone Following Administration of 3 Different Hydromorphone Tamper Resistant Formulations (12 mg) in the Fed and Fasted State, Compared to Palladone® (12 mg) in the Fed and Fasted State (HMP1017), 2006. Purdue Pharma L.P.  Principal Investigator.

144. Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of CBR-2092 in Healthy Volunteers (CBR-2092-001), 2006. Cumbre Pharmaceuticals Inc.  Principal Investigator.

                     GRANTS FROM WITHIN OHIO STATE UNIVERSITY

An Open, Phase I, Multiple Dose, Pilot Study to Investigate the Concentrations of Ellagic Acid and Anthocyanins in Plasma, and the Excretion of 8 Oxo 7, 8 Dihydro 2' Deoxyguanosine (8 OHdG), in Healthy Volunteers Dosed Orally for 14 Days with a Powdered Formulation of Freeze Dried Black Raspberries, 2002.  Environmental Health Sciences.  Co-Principal Investigator.

An Open-Label, Phase I, Multi-Fixed Dose, Pilot Study to Investigate the Pharmacokinetics of Ellagic Acid and Anthocyanins and Safety in Healthy Volunteers Dosed Orally for 7 Days with a Powdered Formulation of Freeze Dried Black Raspberries, 2004.  Environmental Health Sciences.  Co-Principal Investigator.

FEDERAL GRANTS

Influence of Calcium on Bone Mass Formation During Puberty, NIH, $2,952,426. Co-Investigator with Velimir Matkovic, M.D., Ph.D., September, 1991 to 1996.  
 

USE PATENTS

Use of gallium nitrate in the treatment of endotoxic shock, filed 1995, in collaboration with Dr. Nicholas Gerber, Dr. Daniel Mullet, and Mary E. Krecic, awarded 1997.

Treatment of pulmonary inflammation with gallium, filed 1996, in collaboration with Dr. Daniel Mullet and Dr. Nicholas Gerber, awarded December 23, 1997, patent number 5,700,487.
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