Biopharmaceutic Considerations In Drug Product Design And Drug Product Performance, In Vitro


Leon Shargel, Ph.D., R.Ph., is Manager and Founder of Applied Biopharmaceutics LLC, a pharmaceutical consulting company and holds academic appointments as Affiliate Professor, School of Pharmacy, Virginia Commonwealth University. Prior to forming his own company, Dr. Shargel was Vice President, Biopharmaceutics, Sandoz (formerly, Eon Labs). He has over 35 years’ experience in both academia and the pharmaceutical industry. Dr. Shargel has lectured widely on pharmacokinetics, bioavailability and generic drug product development. He has over 200 publications including a leading textbook, “Applied Biopharmaceutics & Pharmacokinetics.” Dr. Shargel received a B.S. in Pharmacy from the University of Maryland and a Ph.D. in Pharmacology from the George Washington University Medical Center. He is a member of various professional societies including the American Association of Pharmaceutical Scientists (AAPS), American Pharmacists Association (APhA) and the American Society for Pharmacology and Experimental Therapeutics (ASPET).

Bioavailability is a measurement of the rate and extent of active drug that becomes available at the site of action. For oral drug products, the drug must be absorbed systemically to achieve the desired therapeutic effect. Biopharmaceutics links the physical and chemical properties of the drug substance and the dosage form to clinical performance. This webinar will demonstrate how biopharmaceutics may be used in the rational design of a drug product to achieve a desired therapeutic objective. The webinar will also discuss the measurement of drug product performance, in vitro, including drug dissolution and in vitro in vivo correlation.  

Learning Objectives

  • Biopharmaceutics and Drug Absorption Process
  • Rate-Limiting Steps in Drug Absorption
  • Relationship of the Active Drug Substance and Formulation Factors Affecting Drug Product Performance
  • Drug Product Performance, In Vitro: Dissolution and Drug Release Testing
  • In Vitro–In Vivo Correlation
  • Biopharmaceutics in Drug Product Design

Who Should Attend

This webinar will be of interest to scientists and managers in the pharmaceutical industry, regulators and other pharmaceutical scientists who want to learn more about the pharmacokinetics  of systemic drug absorption and its applications to the development of oral dosage forms

Pharma (brand) and generic drug companies, faculty and students in the department of pharmaceutical sciences, at various colleges of pharmacy

Topic Background

  • Biopharmaceutic Factors and Rationale for Drug Product Design
  • Rate-Limiting Steps in Drug Absorption
  • Physicochemical Properties of the Drug
  • Formulation Factors Affecting Drug Product Performance
  • Drug Product Performance, In Vitro: Dissolution and Drug Release Testing
  • Compendial Methods of Dissolution
  • Alternative Methods of Dissolution Testing
  • Dissolution Profile Comparisons
  • Meeting Dissolution Requirements
  • Problems of Variable Control in Dissolution Testing
  • Performance of Drug Products: In Vitro–In Vivo Correlation
  • Considerations in the Design of a Drug Product
  • $249.00