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Session 2: Development Strategy Of Complex Generics
Session Chair(s)
So Hee Kim, PhD
Director / Ministry of Food and Drug Safety
National Institute of Food and Drug Safety Evaluation (NIFDS), Korea, Republic of
The challenges faced with complex generics development using advanced technology such as liposome, micelle, transdermal patch and metered dose inhalers etc., we will discuss the characteristics of the active ingredient and formulation to prove equivalence to a reference drug in terms of efficacy, safety, and quality. The regulatory landscape and case studies will be discussed.
Speaker(s)
Development of Complex Generics in US
Markham Luke, MD, PhD
FDA, United States
Director for Therapeutic Performance, Office of Generic Drugs, CDER
Statistical Design Challenges Inherent in Bioequivalence Assessment of Complex Generics
Jessica Kim, PhD
FDA, United States
Supervisory Mathematical Statistician