Leon Shargel, Ph.D.
Applied Biopharmaceutics LLC

Dr. Leon Shargel has over 30 yrs experience as a senior manager in the pharmaceutical industry and as an academic faculty member. He is an active member of various professional societies and has served on various national and international committees. Dr. Shargel has organized and participated in many workshops and symposia. He has lectured widely on biopharmaceutics, generic drug development, bioequivalence and pharmacokinetics. Dr. Shargel is a registered pharmacist and has over 150 publications including several leading textbooks in pharmacy and the pharmaceutical industry. Dr. Shargel also holds academic appointments as Affiliate Associate Professor, Virginia Commonwealth University and Adjunct Associate Professor of Pharmacy, University of Maryland.   CONTACT

elise dunzoElise Dunzo, Ph.D.
Director, Clinical Pharmacology and Pharmacokinetics

Applied Biopharmaceutics LLC

Dr. Elise Dunzo has over 10 years experience in the design and evaluation of preclinical, clinical, bioequivalence and pharmacokinetic studies.  She has been actively involved in drug product development including the development of conventional and modified release formulations. In particular, In addition, Dr. Dunzo has expertise in analyzing the relationship between in vitro drug dissolution/release and in vivo drug absorption profiles for extended release dosage forms including data analyses for in vitro-in vivo correlations (IVIVC).  Dr. Dunzo is an expert in WINNONLIN, Gastro-Plus and MCSim (Monte Carlo Simulation) software.   CONTACT

manish issarManish Issar, Ph.D.
Senior Project Manager

Applied Biopharmaceutics LLC

Dr. Manish Issar has over 6 years experience in biopharmaceutic, bioavailability and bioequivalence aspects of generic product development. Dr. Issar has been involved in the design and evaluation of phase I BA/BE studies for a wide variety of dosage forms including topical and transdermal products. Dr. Issar has a strong background in bio-analysis, pharmacokinetic and pharmacodynamic (PK-PD) evaluation of treatments in asthma and chronic obstructive pulmonary of disease (COPD), with a focus on inhaled glucocorticoids. Dr. Issar is an author and co-author of several chapters and basic research papers describing PK-PD relationships. Currently, Dr. Issar is an Assistant Professor of Pharmacology, College of Osteopathic Medicine, Western University of Health Sciences, Pomona, CA.   CONTACT