Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance

Why Should You Attend:

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. Application of biopharmaceutics allows for the rationale design of drug products.

This webinar will demonstrate how biopharmaceutics may be used in the rational design of a drug product to achieve a desired therapeutic objective. Furthermore, the webinar will discuss the measurement of drug product performance, in vitro, including drug dissolution and in vitro in vivo correlation.

Participants will be introduced to the basic concepts of biopharmaceutics and apply these principles to the design of finished dosage forms (drug products). Participants will learn how the physicochemical properties of the drug substance and the formulation of the drug product affect drug product performance. In addition, participants will consider the rate-limiting steps in drug absorption, the quantitative measurement of in vitro performance using dissolution and drug release testing and the determination of In Vitro–In Vivo Correlation.

Areas Covered in the Webinar:

• 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
• Approaches to Establish Clinically Relevant Drug Product Specifications
• Drug Product Stability
• Considerations in the Design of a Drug Product
• Drug Product Considerations

Who Will Benefit:

The following personnel in pharmaceutical Industry will benefit from this training:

• Scientists and managers
• Product development
• Quality Control and Research
• Faculty
• Students

Leon Shargel
Manager and Founder, Applied Biopharmaceutics LLC

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

Topic Background:

Biopharmaceutics is the study of the physicochemical properties of the drug and the drug product, in vitro, as it relates to the bioavailability of the drug, in vivo, and its desired therapeutic effect. Biopharmaceutics links the physical and chemical properties of the drug substance and the dosage form to clinical performance.

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