Analytical Method Development and Validation

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. This text also presents an overview of Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) regulatory guidelines.

List of contents

Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.

About the author

Michael E. Swartz, Ira S. Krull

Summary

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. This text also presents an overview of Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) regulatory guidelines.

Product details

• Authors: Michael E. Swartz, Michael E. (Synomics Pharmaceuticals Svcs Swartz
• Assisted by: Ira S. Krull (Editor), Krull Ira S. (Editor), Michael E. Swartz (Editor), Swartz Michael E. (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 31.12.2017
• EAN: 9781138402560
• ISBN: 978-1-138-40256-0
• No. of pages: 96
• Subjects: Natural sciences, medicine, IT, technology > Chemistry > Theoretical chemistry; SCIENCE / Chemistry / Analytic, Analytical Chemistry