THIS WEBINAR ON BIOEQUIVALENCE WILL USE A CASE STU 2013 - Introduction to Bioequivalence and Therapeutic Equivalence

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Category bioequivalence regulations; pharmaceutical equivalence; therapeutic equivalence; approval of bioequivalent medications; bioequivalent drug marketing; bioequivalent drug approval

Deadline: June 26, 2013 | Date: June 26, 2013

Venue/Country: Online Event, U.S.A

Updated: 2013-06-14 14:28:13 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

Both the pharmaceutical industry and the FDA have been subject to scrutiny and criticism concerning the approval and marketing of bioequivalent drugs. It is imperative that pharmaceutical and biotechnology personnel are well-acquainted with the regulations and the successes and challenges to approval that have preceded their efforts. Familiarity with both will ease the path to successful approval of an Abbreviated New Drug Application (ANDA) and ensure marketing compliance for bioequivalent drugs.

This webinar will explore the regulatory issues relevant to the approval of medications designed to be bioequivalent with already-marketed drugs. In addition to reviewing the regulatory definitions of bioequivalence, pharmaceutical equivalence and therapeutic equivalence, the program will review approval requirements for drugs in special categories, including critical dose drugs and modified release products. Finally, selected examples of compliance and non-compliance with FDA policies will be discussed.

The program will review case studies of critical dose drugs with a narrow therapeutic window and products undergoing re-formulation as modified release products, and the FDA's Orange Book coding for bioequivalence, discussing potential approval and marketing implications. Examples of compliance and non-compliance with FDA requirements will be presented.

Learning Objectives:

By the completion of this program, participants will be able to

• Identify the FDA requirements for a successful ANDA by demonstrating bioequivalence for drug products
• Describe the relationships among bioequivalence, pharmaceutical equivalence and therapeutic equivalence
• Interpret the FDA Orange Book coding of equivalence
• Discuss the equivalency considerations for critical dose and modified release pharmaceutical products