Adel Karara


  • Adele Karara

    Adel H. Karara, Ph.D., FCP 
    Professor, Pharmaceutical Sciences


    Education

    • Ph.D. – Pharmacokinetics (1983) Washington State University, Pullman, WA
    • M.S. – Industrial Pharmacy (1977) Alexandria University, Alexandria, Egypt
    • B.S. - Pharmacy (1974) Alexandria University, Alexandria, Egypt

    Bio

    Dr. Karara, is Professor of Pharmaceutical Sciences, teaches in the areas of pharmaceutics, biopharmaceutics and pharmacokinetics. Prior to joining UMES, he held senior positions in the pharmaceutical industry. His research had been primarily in the female health care area working on the pharmacokinetics/dynamics of combination hormone treatments. As Senior Clinical Pharmacologist at Roche, he had the responsibility for guiding the selection of early drug discovery compounds, due diligence projects and design of clinical pharmacology development programs for several metabolic drug candidates. Before joining Roche, he was Director at Berlex where he provided NDA support for Yasmin®, ClimaraPro® Menostar® and Angeliq®. At Novartis, he provided support for Starlix®, Lescol® and Neoral®.  Dr. Karara was a tenured faculty at University of Louisiana where he mentored 3 PhD & 2 MS students and won the researcher of the year award. Dr. Karara is a Charter member of American Association of Pharmaceutical Scientists (AAPS), participated in teaching short courses and served on abstract screening committees. Dr. Karara was elected to serve as the Chair of the Clinical Pharmacology and Translational Medicine Section of AAPS. He has 39 peer reviewed publications and was invited speaker at several clinical pharmacology forums.  He served on Pharmaceutical Research and Manufacturers of America, Clinical Pharmacology Technical Group where he led the exploratory Investigational New Drug (IND) survey initiative.  Dr. Karara currently serves on the FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee for oncology drugs (ODAC).   Dr. Karara is a fellow of American College of Clinical Pharmacology and serves on the editorial board of the Journal of Clinical Pharmacology.

    Courses Taught

    Professional: PHAR 530 Pharmaceutics and Biopharmaceutics; PHAR 531 Pharmacokinetics
    PHAR 630 Sterile Products; PHAR 690 Early Clinical Drug Development; PHAR 799 Professional Seminar; PHAR 524 Toxicology

    Graduate Level: PSGP 821 Clinical Pharmacology & Drug Development and PSGP 805 Dosage Forms  and Advanced Drug Delivery Systems

    Scholarly Activities: http://www.ncbi.nlm.nih.gov/pubmed/?term=Karara+AH

    Karara, AH,  Hines, R., Demir, Z., Nnorom, B., Horsey, R.,  and Twigg, G. “Evaluation of the most frequently prescribed extemporaneously compounded veterinary medications at a large independent community pharmacy” International J of Pharmaceutical Compounding, 20(6)461-467 (Nov-Dec 2016). PMID:28339384

    Karara, AH, “ FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary” American Association of Pharmaceutical Scientists, AAPS Open, 2(1):1-3 (2016).  DOI:10.1186/s41120-016-0007-0 http://aapsopen.springeropen.com/articles/10.1186/s41120-016-0007-0

    Sherr, Z. and Karara, AH,  “Evaluation of the most frequently prescribed extemporaneously compounded medications in a rural setting: A case study from the Delmarva Peninsula” International J of Pharmaceutical Compounding, 18(6): 462-468 (2014). PMID:25906622

    Karara, AH, Harrison, LI, Melikian, AP, Poola, N, Morrison, D, Bourg D, Bourg, L and Zurth, C, Pharmacokinetics of continuous once-a-week combination 17 β-estradiol/low-or high-dose levonorgestrel transdermal delivery systems in postmenopausal women, Journal of Clinical Parmacology,2014, 54(5), 520-527. PMID:24474034

    Karara, AH, Career path and the skill set for Pharm Ds as clinical pharmacology scientists: A case study and perspective of a former industry scientist, Currents in Pharmacy Teachings and Learning, 2013, 5(4), 331-339. DOI: 10.1016/j.cptl.2013.01.017

    Karara, AH, Edeki, T, McLeod, J, Tonelli, A and Wagner JA, PhRMA survey on the conduct of first-in-human trials under exploratory INDs, Journal of Clinical Parmacology,2010, 50(4), 380-391. PMID:20097935

    Karara, AH, HanesV, Alonso A, Ni P, Poola N, Silang R, Blode H. and Preston R, Pharmacokinetics and pharmacodynamics of drospirenone-estradiol combination hormone therapy product coadministered with hydrochlorothiazide in hypertensive postmenopausal women,  Journal of Clinical Pharmacology, 2007,47(10):1292-1302. PMID:17906162

    Preston RA, Norris PM, Alonso A, Ni P, Hanes V, and Karara, AH, Randomized, placebo-controlled, trial of the effects of drospirenone-estradiol on blood pressure and potassium balance in hypertensive postmenopausal women receiving hydrochlorothiazide, Menopause, 2007,14(3): 408-414. PMID:17224857

    Hinderling PH, Karara AH, Tao B, Pawula M, Wilding I and Lu M, Systemic availability of the active metabolite hydroxyl-fasudil after administration of fasudil to different sites of the human gastrointestinal tract, Journal of Clinical Pharmacology, 2007, 47:19-25. PMID:17192498

    Harrison LI, Zurth C, Gunther C, Karara AH, Melikian A and Lipp R, Simultaneous estradiol and levonorgestrel transdermal delivery from a 7-day patch: In vitro and In vivo drug delivery of three formulations, Drug Development and Industrial Pharmacy, 2007, 33: 373-380. PMID:17523002


    Areas of Interest and/or Experience

    • Pharmacokinetic/pharmacodynamics modeling of uptake and disposition of drug agents. Clinical pharmacology development plans for new drug candidates. Enhancement of bioavailability of poorly soluble compounds.
       

    Current Research Activities

    • Pharmacokinetic and pharamcodynamic analysis of data from clinical trials