Leon Shargel, Ph.D.
Manager and Founder
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

Martin C. Shargel, M.D.
Medical Director
Applied Biopharmaceutics LLC

Martin C Shargel, MD has been a practicing physician for over 35 years and has been the Medical Director at multiple nursing and rehabilitation facilities. Dr. Shargel received a B.S. in Pharmacy (Magna Cum Laude) from the University of Maryland (Baltimore, MD) and an M.D. from the Medical College of Virginia (Richmond, VA). Dr. Shargel was an Intern and Resident in Internal Medicine at the University of Maryland Hospital (Baltimore, MD). In addition, Dr. Shargel served as a Captain in the Medical Corps of the US Air Force. Following his service, Dr. Shargel was a senior resident, Georgetown Medical Division, DC General Hospital, Pulmonary Fellow, DC General Hospital, Washington, DC. Dr. Shargel is certified by the American Board of Internal Medicine (Internal Medicine) and by the American Board of Internal Medicine (Geriatrics). He has had appointments as Clinical Professor of Medicine at George Washington University (Best Teacher Award); Chairman, Department of Medicine at Washington Adventist Hospital; Chairman, Peer Review Committee, Montgomery County Medical Society, Commissioner of Health, Montgomery County, MD, and Member, Peer Review Committee, Maryland Medical Society. Dr. Shargel was a former member of the Ethics Committee with the Maryland Medical Society; and member of the Board of Directors with the District of Columbia Lung Association. He is a member of the D.C. Lung Association, the American Thoracic Society, the American Medical Association, the Southern Medical Society (Montgomery County), the Maryland Medical Society, and the Medical and Chirurgical Society of Maryland.

Elise 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 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