Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

Why Should You Attend:

Bioavailability is a measure of the rate and amount of drug that gets systemically absorbed and is available to the site of action. The ability to quantitate drug bioavailability and to compare drug bioavailability (bioequivalence) to different formulations of the same drug provide evidence that drug product performance is consistent and will produce a predictable therapeutic effect. These studies are used for the development of new drug formulations and for the development of generic drug products as part of the regulatory requirement for therapeutic equivalence.

This webinar will provide an understanding of the measurement of bioavailability, the design of bioequivalence studies, the statistical evaluation of the results and how these results relate to the development of new and generic drug products. Practical examples will emphasize the types of drug substances and drug products that have bioavailability and/or bioequivalence problems.

The webinar will also discuss whether bioequivalence studies are needed for all drugs, for different drug doses and for post-approval formulation changes.

Areas Covered in the Webinar:

• Drug product performance and drug product quality
• Absolute and relative bioavailability
• Bioavailability and bioequivalence as measures of in vivo drug product performance
• Bioequivalence studies in new drug and generic drug development
• Methods for the measurement of bioavailability
• Statistical designs for bioequivalence studies
• Statistical criteria for bioequivalence and evaluation of the data
• Therapeutic equivalence and generic drug product approval
• Bio waivers and rationale for not to performing bioequivalence studies
• Scale up and post approval studies (SUPAC)
• Issues in demonstrating bioequivalence for specialized drug substances and drug products

Who Will Benefit:

This webinar will provide valuable assistance to personnel working as bench chemist/analyst, supervisor, manager, director or vice president in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, in the following areas:

• Pharmaceutical Development
• Setting up Analytical Methods (Pharmacopeial, regulatory or in-house developed)
• R & D, both analytical and formulation
• Project Management
• Quality Control
• Quality Assurance
• Regulatory Affairs

Leon Shargel
Manager and Founder, Applied Biopharmaceutics LLC

Leon Shargel, Ph.D., R.Ph., is a 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).

Dr. Shargel 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 Pharmaceutical Scientists (AAPS), American Pharmacists Association (APhA) and the American Society for Pharmacology and Experimental Therapeutics (ASPET).

Topic Background:

Drug product performance, in vivo, is defined as the release of the drug substance from the drug product leading to the bioavailability of the drug. The evaluation of drug product performance relates bioavailability to the therapeutic response and adverse events. Bioavailability and bioequivalence studies are measurements of drug product performance and can be used to evaluate new drug formulations, changes in drug formulations and development of generic drug products.

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