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The Critical Path to Establishing Equivalence of Advanced Dosage Forms
Thursday, November 15
7:00 am – 8:15 am
Thursday Sunrise Sessions are Funded by a Grant from
Sunrise Session
ACPE #073-999-07-569-L04
The critical path initiative launched by the Food and Drug Administration (FDA) provides opportunities for acceleration of innovative medical therapies to patients. In addition, the initiative encourages the development of new tools and methodology for regulatory approval of drug products. This is particularly important in the area of equivalence evaluation of innovative or advanced dosage forms with respect to drug release profile, direction of drug delivery, excipients, manufacture, and perceived unmet medication, such as liposomes, implants, drug-eluting stents, nanotech-derived products, where conventional methods and tools may not be sufficient or adequate for assessment of ‘sameness’ between products. This session will bring together pharmaceutical scientists to (1) discuss critical factors that may influence product quality and performance, hence equivalence of innovative dosage forms or pharmaceutical products, (2) identify novel or emerging tools/methods for product assessment and equivalence evaluation, and (3) consider the critical path for establishing equivalence of these dosage forms or pharmaceuticals.
Moderators
Mei-Ling Chen, Ph.D.
U.S. Food and Drug Administration
Vincent H.L. Lee, Ph.D.
Chinese University of Hong Kong
Novel Approaches for Evaluating Equivalence of Advanced Dosage Forms
Mei-Ling Chen, Ph.D.
U.S. Food and Drug Administration
Dosage Forms of the 21st Century: Relevance of Bioequivalence?
Vincent H.L. Lee, Ph.D.
Chinese University of Hong Kong