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	Peptide Drug Challenges through Pre-ANDA Processes u0026 Case Studies (6of39) Complex Generics 2018 (U.S. Food and Drug Administration) View
	Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018 (U.S. Food and Drug Administration) View
	Pre-ANDA Program Update and Tips for Success – OPQ Perspective (U.S. Food and Drug Administration) View
	Andrew Isidoridy: Evaluating immunogenicity risk of complex peptide products (ProImmune thinkpeptides) View
	Establishing Appropriate BE Limits for Complex Formulations (14of39) Complex Generics 2018 (U.S. Food and Drug Administration) View
	Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies (U.S. Food and Drug Administration) View
	GDUFA II (9/28) Generic Drugs Forum 2017 (U.S. Food and Drug Administration) View
	FDA 505(b)(2) Applications Seminar Part IV: The Thin Line between a 505(j) and 505(b)(2) (Regis Technologies, Inc.) View
	Peptide Drug Conjugates:- A Novel Drug Design Approach (MADD Chemistry) View
	Considerations in Demonstrating Complex API Sameness (7of39) Complex Generics 2018 (U.S. Food and Drug Administration) View