CMC Sections of Regulatory Filings and CMC Regulatory Compliance during Investigational and Postapproval Stages

Introduction ... 200 Pharmaceutical Quality ... 200Drug Substance ... 201 Manufacture ... 202 Characterization (Structure Elucidation)... 204 Control of Drug Substance (Specifications) ... 205 Reference Standards or Materials ... 206 Container Closure System ... 206 Stability ... 207 Drug Product .....

Ausführliche Beschreibung

Bibliographische Detailangaben

Format:	Buchkapitel
Sprache:	eng
Schlagworte:	MEDICINE: GENERAL ISSUES
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!