Pharmacokinetics of Oral Absorption

Why Should You Attend:

Participants will be introduced to pharmacokinetic principles that can be applied to systemic drug absorption. These principles will be applied to biopharmaceutics’ processes that relate the physical/chemical properties of the drug substance and the dosage form to systemic drug absorption.

Participants will be able to distinguish between zero and first order rate processes and how these processes relate to drug release and drug absorption from immediate release and modified release dosage forms. In addition, pharmacokinetics will be applied to the quantitative measurement of the rate and extent of drug absorption relate to bioavailability and bioequivalence of dosage forms.

Areas Covered in the Webinar:

• Drug absorption process
• First order and zero order kinetics
• Drug release from immediate release and modified release dosage forms
• Calculation of the fraction of dug absorbed
• IVIVC
• Bioavailability and bioequivalence
• Influence on pharmacokinetic parameters such as ka and kel influence bioavailability and therapeutic response

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:

A drug is a chemical substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Most drugs are given orally to the patient and must be absorbed systemically to achieve the desired therapeutic effect.

The pharmacokinetics of drug absorption considers the rate and amount of drug that gets systemically absorbed regardless of the physiologic processes. The ability to quantitate drug absorption kinetics allows for the development of new dosage forms, development of dosage regimens, individualization of drug therapy, and to relate the drug dose to the therapeutic effect.

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