Andre Jackson, PhD

**** ***** ***** ***** ****** Spring, Maryland 20906

301-***-**** adwopd@r.postjobfree.com

PHARMACOLOGIST/ PHARMACOLOGICAL CONSULTANT

Neuropharmacology Bioequivalence Generic & New Drugs

Seasoned Pharmacologist with over 47 years of varied academic and professional research experience and 30 years of experience working at the Food and Drug Administration, possessing vast knowledge of pharmacokinetics. Established comprehensive portfolio of published academic works in far-reaching industry journals and textbooks, consistently providing colleagues, peers, and students with access to cutting-edge research and understanding of newly founded discoveries and their use within pharmacology. Has made significant contributions to field by way of grant funded research and presentations of numerous project findings at prestigious and influential pharmacology conferences.

Academic Research & Writing

Research Finding Presentation

Laboratory Protocol & Conduct

Lab Data Analysis & Application

Toxicology

Pharmacokinetics

Metabolites in Bioequivalence

Urine Sample Collection Methods

Liposomes

Bioequivalence

Generic & New Drugs

Generics in Bioequivalence

Professional Experience

Currently-Retired From FDA April 2015

Working on the Development of a Physiological Model for d and l pharmacokinetics and pharmacodynamics of extended-release methylphenidate in children and adults.

FOOD AND DRUG ADMINISTRATION, Rockville, MD 1984 – 2015

Pharmacologist, Division of Neuropharmacology (2002-2015)

Have become an expert in extended-release methylphenidate products such as Concerta, and Ritlain LA. Sponsors use model I published in the Pharmaceutical Research to analyze data in their methylphenidate submissions to the FDA. 10 years experience reviewing Psychiatric Drug Products. Wrote some limited Pharmacometric reviews on drug products. Provide service to sponsors by answering submitted questions related to Clinical Pharmacology in the development of their drug.

Develops new drugs-reviewed NDAs, supplements, study amendments, pediatric written requests, and Protocols for new molecular entities and for 505b(2) submissions related to formulation changes for currently marketed drugs. Experience in reviewing numerous types of drug products such as dermal patches, oral tablets, inhalation solutions etc.

Extensive experience programming in SAS and using Nonmem. Programming capabilities in R.

Pharmacologist, Division of Bioequivalence (1984 – 2002)

Completed generics-reviewed bioequivalence studies (ANDAs), waivers, amendments, and bioequivalence protocols. Has made major contributions as to how best to analyze the data from bioequivalence studies based upon publications which have been impactful in the area of bioequivalence.

UNIVERSITY OF MARYLAND, SCHOOL OF PHARMACY Baltimore, MD 1979 – 1984

Assistant Professor

Worked at The University of Maryland’s School of Pharmacy as an Assistant Professor teaching pharmacy courses for graduate and undergraduate students, supervising pharmacy lab sessions, leading small group discussions with students, and holding office hours to help students with questions about coursework.

Participated in pharmacological research, and observed, recorded, and analyzed results often documenting information and conclusions in academic writing.

HOWARD UNIVERSITY, SCHOOL OF PHARMACY Washington, DC 1976 – 1979

Assistant Professor

Worked at Howard University’s School of Pharmacy as an Assistant Professor teaching pharmacy courses for undergraduate students, supervising pharmacy lab sessions, leading small group discussions with students, and holding office hours to help students with questions about coursework.

Participated in pharmacological research, and observed, recorded, and analyzed results often documenting information and conclusions in academic writing.

BRISTOL LABORATORIES Syracuse, NY 1975 – 1976

Senior Research Assistant

Senior Research Scientist involved in pre-clinical and clinical drug studies for drug development

Made significant contributions to Bristol’s research goals in the development programs for several currently marketed drugs.

Conducted off-site metabolism studies in Rhesus monkies

UNIVERSITY OF FLORIDA Gainesville, FL 1972 – 1975

Post Doctoral Fellow, Edward R. Garrett Fellow

Conducted research on the Pharmacokinetics of Morphine in Dogs

Instructor in a pharmacokinetic workshop for Industry conducted by Ed Garrett

Funded Research

SUSTAINED RELEASE PHARMACOKINETICS OF LIPOSOME ENTRAPPED DRUGS 1978-1980

Principal Investigator

Led investigation with new investigator funding of $125,000 from the National Institutes of Health.

IN VIVO ASSESSMENT OF DRUG EXCIPIENT INTERACTIONS: I AcDiSolChlorpheniramine 1982

Co-Principal Investigator

Helped lead research team to conduct project with $10,000 funded by the Food Machinery Corporation.

PHARMACOKINETICS OF 5FU FOLLOWING REGIONAL CHEMOTHERAPY 1984

Co-Investigator

Coordinated with research team to complete project with $125,000 approved but not funded by the National Institutes of Health.

Publications in Refereed Journals

1. Improved Tissue Solubilization for Atomic Absorption Spectroscopy. A.J. Jackson, L.M. Michael, H.J. Schumacher. Anal. Chem., 44:1065(1972)

2. Comparative Human Oral Clinical Pharmacology of Cefadroxil, Cefalexin,and Cephradine, M. Pfeffer. A.J. Jackson, J. Ximenes, J.P. DeMenezes. Antimicrobial Agents and Chemotherap., 22:331338(1975)

3. The Teratogenic Activity of a Thalidomide Analog, EM12 in Rats on a Low Zinc Diet. A.J. Jackson, H.J.Schumacher. J. Teratol, 19:341344(1979).

4. Pharmacokinetics of Morphine and its Surrogates III Morphine and its 3Monoglucoronide Pharmacokinetics in the Dog as a Function of Dose. E.R. Garrett, A.J. Jackson. J. Pharm Sci., 68:753771(1979).

5. Identification of Urinary Metabolites of EM12 N(2',6'dioxopiperiden3yl) phthalimidine, a Teratogenic Analog of Thalidomide, in Rats and Rabbits. A.J. Jackson, H.J. Schumacher. Can J. Pharm. Sci., 15:2123(1980).

6. The Effect of Route of Administration on the Disposition of Inulin Encapsulated in Multilamellar Vesicles of Defined Particle Size. A.J. Jackson. Res. Commun. Chem. Pathol.Pharmacol., 32:293304 (1980).

7. Intramuscular Absorption and Regional Lymphatic Uptake of Liposome Entrapped Inulin. A. J. Jackson. Dr. Met. and Disp., 9:535540(1980).

8. Determination of Meperidine Blood to Plasma Concentration Ratio, Effect of Temperature and pH. A.J. Jackson. Res. Commun. Chem. Pathol. Pharmacol., 32:365368(1981).

9. Human Blood Preservation: Effect on In Vitro Protein Binding. A.J. Jackson, A.K. Miller, P.K. Narang. J. Pharm.Sci., 70:1168(1981).

10. Plasma Pharmacokinetics of Intravenously Administered Atropine in Normal Subjects. R.G. Adams, P. Verma, A.J. Jackson, R.L. Miller. J. Clin.Pharmacol., 22:447481(1982).

11. Novel Device for Quantitatively Collecting Small Volumes of Urine from Laboratory Rats. A.J. Jackson, J.C. Sutherland. J. Pharm. Sci., 6:816818(1984).

12. Serum Pharmacokinetics of Intravenously Administered Desmosine in Sheep. P.S. Verma, R.F. Hoyt Jr., A.J.Jackson, Y.Y. Phillips. J. Conn. Tissue Research., 12:191197(1984).

13. Liposome Entrapped Diethylstilbestrol (DES) Effect Upon Prostate Gland and Plasma Testosterone Levels in Rats. A.J. Jackson, R.B. Franklin. J. of Endocrinol. 115:538548(1984).

14. Pharmacokinetics of 5Fluorouracil in the Canine Model Following Different Routes of Intrahepatic Administration. M.S. Didolkar, D. G. Covell, A.J. Jackson, A. P.Walker, S.R. Kalidindi. J. Cancer.Research, 44:51055109(1984).

15. Unresectable Hepatic Metastases from Colorectal Carcinoma: Does Dearterialization and Infusion Chemotherapy Alter the Course of Disease and Survival? M.S. Didolkar, E.G. Elias, N.O. Whitley, A.J. Jackson, R.J. Hebel, T.E. Jordan. Surgery Gynecology and Obstetrics, 160:429436(1985).

16. Simultaneous Determination of Dacarbazine, Its Photolytic Degradation Product, 2Azahypoxanthine,and the Metabolite 5Aminoimidazole4Carboxamide in Plasma and Urine by High Performance Liquid Chromatography. D. Fiore, A.J. Jackson, M. S. Didolkar, V.R. Dandu. J. Antimicrobial Agents and Chemotherapy, 27:977979(1985).

17. Toxicity and Complications of Vascular Isolation and Hyperthermia Perfusion with DTIC in Melanoma: (Phase I Study). M.S. Didolkar, J.L. Fitzpatrick, A.J. Jackson, G.S.Johnson. J. Cancer Research,57:19611966(1986)

18. Application of Moment Analysis in Assessing Rates of Absorption for Bioequivalency Studies. A.J. Jackson, Mei-Ling Chen. J. Pharm.Sci., 76:69(1987)

19. Prediction of Steady State Bioequivalence Relationships Using Single Dose Data Linear Kinetics. A.J. Jackson. Biopharmaceutics and Drug Disposition, 8,483496(1987)

20. Prediction of Steady State Bioequivalence Relationships Using Single Dose Data II Nonlinear Kinetics. A.J. Jackson. Biopharmaceutics and Drug Disposition, 10, 489-503 (1989)

21. Influence of the Routes of Continuous Intrahepatic Infusion of 5Fluorouracil on its Pharmacokinetics. M.S. Didolkar, A.J. Jackson, D.G. Covell, A.P. Walker, N.D. Eddington. J.Surgical Oncology,41,187-193,(1989)

22. Suitability of Measured AUC Estimates for Use In Bioequivalence Determinations: Relationship to AUC(0-INF). M. Martinez, A.J. Jackson. Pharmaceutical Res., 8,512-517,(1991).

23. Easy and Practical Use of CONSAM for Simulation, Analysis and Optimization of Complex Dosing Regimens. A.J. Jackson, L. Zech. J.Pharm Sci,80,317-320,(1991).

24. The Role of Metabolites in Bioequivalency Assessment I-Linear Pharmacokinetics without First-Pass Effect. M.L. Chen, A.J. Jackson. Pharmaceutical Res.,8,25-32,(1991).

25. Inappropriate Inclusion of Non-Quantifiable Plasma Concentrations in the Estimation of Extent of Absorption. A.J. Jackson. Biopharm. and Dr. Disp., 13, 629-634(1992).

26. Comparison of Single and Multiple Dose Pharmacokinetics Using Clinical Bioequivalence Data and Monte Carlo Simulations. A.A. El-Tahtawy, A.J. Jackson, T.M. Ludden. Pharmaceutical Res., 11, 1330-1336, (1994).

27. The Role of Metabolites in Bioequivalency Assessment II. Drugs with Linear Pharmacokinetics and First-Pass Effect. M.L. Chen, A.J. Jackson. Pharmaceutical Res., 12, 700-708, (1995).

28. Evaluation of Bioequivalence of Highly Variable Drugs Using Monte Carlo Simulations: I-Estimation of Rate of Absorption for Single and Multiple Dose Trials Using Cmax. A.A. El-Tahtawy, A.J. Jackson, T.M. Ludden. Pharmaceutical Res., 12, 1634-1641, (1995).

29. Pharmacokinetics of Dacarbazine in the Regional Perfusion of Extremities with Melanoma. M.S. Didolkar, A.J. Jackson, L.J. Lesko, J. L. Fitzpatrick, B.S. Buda, G.S. Johnston, L.A. Zech. J. Of Surgical Oncology, 63, 148-158, (1996).

30. Evaluation of Orally Administered Highly Variable Drugs and Drug Formulations. V.P. Shaw, A.J. Jackson, et.al. Pharmaceutical Res. 13,1590-1594, (1996).

31. Evaluation of a Cmin and a Cmin Normalized Method for the Confirmation Steady-State in Bioequivalence Studies. A.J. Jackson. Pharmaceutical Res., 15, 1077-1084, (1998).

32. Use of Truncated AUC to Measure Extent of Drug Absorption in Bioequivalence Studies: Effects of Drug Absorption Rate and Elimination Rate Variability on this Metric. J. Kharidia, A.J. Jackson, L. Ouderkirk. Pharmaceutical Res. 16, 130-134, (1999).

33. Truncated Area Under the Curve as a Measure of Relative Extent of Bioavailability: Evaluation Using Experimental Data and Monte Carlo Simulations. A.J. Jackson, L. Ouderkirk. Pharmaceutical Res. Letter to the Editor, 1144-1146, (1999).

34. Dose Dependent Pharmacokinetics of Amphotericin B Lipid Complex in Rabbits. T.J. Walsh, A.J. Jackson, J.W. Lee, M. Amantea, T. Sein, J. Bacher, L. Zech. Antimicrobial Agents and Chemotherapy, 44, 2068-2076, (2000).

35. First Measured Plasma Concentration Value as Cmax; Impact on the Cmax Confidence Interval in Bioequivalence Studies. A.J. Jackson, D.P. Conner, R. Miller. Biopharm. and Drug Disp. 21, 139-146, (2000).

36. The Role of Metabolites in Bioequivalency Assessment: III. Highly Variable Drugs with Linear Kinetics and First-Pass Effect. A.J. Jackson. Pharmaceutical Res. 17, 1-5, (2000).

37. Evaluation of a Limited Sampling Method Used to Determine the Bioequivalence of Highly Variable Drugs with Long Half-Lives. A.J. Jackson. Biopharm. and Drug Disp. 22, 179-190, (2001).

38. Determination of In Vivo Bioequivalence. A.J. Jackson. Pharmaceutical Res. 19,1-2, (2002).

39. Effect of Length of Sampling Schedule and Washout Interval on Magnitude of Drug Carry-Over From Period 1 to Period 2 in Two-Period, Two-Treatment Bioequivalence Studies and its Attendant Effects on Determination of Bioequivalence. K. Dhariwal, A.J. Jackson. Biopharm. and Drug Disp. 24, 219-228, (2003).

40. Metabolites and Bioequivalence. A.J. Jackson, Gabriel Robbie, Patrick Marroum. Clinical Pharmacokinetics, 43, 655-672, (2004).

41. Evaluation of the Impact of Metabolites for Drugs that Undergo Non-Linear Pharmacokinetics and Exhibit Low and High Intrasubject Variability on Bioequivalence using Single-Dose Simulations. April C. Braddy, A. J . Jackson. J. Pharm. Sci 2009.

42. Bioavailability Considerations in Evaluating Drug-Drug Interactions Using the Population Pharmacokinetic Approach. J. Z. Duan, A. J. Jackson, Ping Zhao. The Journal of Clinical Pharmacology. 2011 Jul;51(7):1087-1100.

43. Bioequivalence of Long Half-life drugs -Informative Sampling Determination-Parallel Designed Studies. A. El-Tahtawy, F. Harrison, J. F. Zirkelbach, Andre J. Jackson. Journal of Pharmaceutical Sciences 2012 Nov;101(11):4337-46. doi: 10.1002/jps.23296. Epub 2012 Aug 24.

44. Individualized, Discrete Event Simulations Provide Insight into Inter- and Intra-Subject Variability of Extended-Release Drug Products. S.J. Kim, A. J. Jackson, R. Hur, C. A. Hunt. Theor Biol Med Model 9:39(2012).

45. Use of Partial AUC (PAUC) to Evaluate Bioequivalence - A Case Study with Complex Absorption: Methylphenidate. J. F. Zirkelbach, A. J. Jackson, Y. Wang, D. Schuirmann. Pharm Res. 2012 Sep 25

46. Use of Partial Area Under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations. E.M. Stier, BM. Davitt, O. Chandaroy, M.L. Chen, J.F. Zirkelbach,A.J. Jackson, et. al.. AAPS J. 2012 Dec;14(4):925-6. doi: 10.1208/s12248-012-9397-7.

47. Impact of Release Mechanism on the Pharmacokinetic Performance of PAUC Metrics for Three Methylphenidate Products with Complex Absorption. Andre J. Jackson. Pharm Res DOI 10.1007/s11095-013-1150-0, Pharmaceutical Research, Volume 31, Issue 1 (2014), Page 173-181

48. Quantitative Drug Benefit-Risk Assessment: Utility of Modeling and Simulation to Optimize Drug Safety in Older Adults. V. Crentsil, J. Lee, A. J. Jackson. Annals of Pharmacotherapy 2014. 48, 306-313

49. The Food and Drug Administrations Perspective on a New Antidepressant-Vortioxetine. Zhang, J., Mathis, M., Sellers, J.W., Kordzakhia, G., Jackson, A.J., Dow, A., Yang, P., Fossom, L., Zhu, H., Patel, H., Unger, E.F.,Temple, R.J. Journal of Clinical Psychiatry 2014

50. In Silico, Experimental, Mechanistic Model for Extended-Release Felodipine Disposition Exhibiting Complex Absorption and a Highly Variable Food Interaction. Kim, S.H.J., Jackson, A.J., Hunt, C.A. PLOS ONE 2014 SEP 30:9(9) e108392. doi: 10.1371/journal.pone.0108392. eCollection

51.A Semi-physiologically-based model for Methylphenidate pharmacokinetics in adult humans. Journal of Bioequivalence and Bioavailability. A. J. Jackson, 11,2, 29-37,2019. DOI: 10.4172/0975-0851.1000390

52. Considerations for Conducting Bioequivalence Studies on Complex Delayed-release, Long Acting Injections and Sustained-release Formulations. Acta Scientific Pharmacology, A.Jackson Volume 3(3), 2022.

53. Semi-Physiological based Population Pharmacokinetic Model for Methylphenidate Hydrochloride Multi-Layer Extended Release (Aptensio XR®) Capsules in Children ages 4-12 and Adults Jackson A.J., Brundge R., Ette E., and Chaudhary I., Journal of Bioequivalence and Bioavailability, 14,(6) DOI: 10.35248/0975-0851.22.14.474, 1-10,2022.

54. A Simulation Study of the Comparative Performance of Partial Area under the Curve (pAUC) and Partial Area under the Effect Curve (pAUEC) Metrics in Crossover Versus Replicated Crossover Bioequivalence Studies for Concerta and Ritalin LA, Jackson A.J., and Foehl H.C., AAPS Journal, July, 2022, https://doi.org/10.1208/s12248-022-00726-w

Education

Doctor of Philosophy, Toxicology, University of Cincinnati, Cincinnati, OH

Bachelor of Science, Biology, Towson State College, Baltimore, MD

Credentials & Relevant Experience

Journal of Clinical Pharmacology, Referee

Journal of Pharmaceutical Sciences, Referee

Biopharmaceutics and Drug Disposition, Referee

U.S. Patent, Apparatus for/Methods of Collecting Urine from Laboratory Animals, Patent #4476879

CRC Press, Textbook Editor, Generics and Bioequivalence, Boca Raton, FL, 1994

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