This book provides information about the analytical methods and strategies for quality control of clinical supplies and commercial products in the pharmaceutical industry. It describes the analytical methods used, presents an overview of validation and method transfer, and discusses the strategy for establishment of specifications. The text addresses the types of studies needed to support development and details a phased approach to development. It also explains how the development cycle relates to analytical development guidance on designing a control strategy and to quality by design. The authors conclude with commentary on the current regulatory environment.
Reihe
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für höhere Schule und Studium
Für Beruf und Forschung
Professional Practice & Development
Illustrationen
150 s/w Abbildungen
150 Illustrations, black and white
Maße
Höhe: 234 mm
Breite: 156 mm
ISBN-13
978-1-4398-7966-5 (9781439879665)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Klassifikation
Terrence P. Tougas, Cornelia Field, Dennis O'Connor, and Rajni Patel are with Boehringer Ingelheim Pharmaceuticals, Inc. in Connecticut, USA.
Scope of Analytical Methods Used For Pharmaceutical Development and QC of Clinical Supplies and Commercial Products. Overview of Pharmaceutical Regulatory Environment. Development Cycle and Relationship to Analytical Development. Designing a Control Strategy and Its Relationship to QbD. Establishment of Specifications. Validation or Analytical Procedures. Method Transfer.
