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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)
New Concept in the Method of Equivalence Study and Cases
Choong Yul Ahn
Ministry of Food and Drug Safety, Korea, Republic of
Senior Reviewer of Bioequivalence Evaluation Division
Case Studies: Liposomes and Nanoparticles
Younghwan Park
SN BioScience Inc., Korea, Republic of
CEO & Founder