Development and Validation of Analytical
โ Christopher M. Riley and Thomas W. Rosanske (Eds.)
๐ Library
๐
1996
๐ Academic Press, Elsevier
โฆ LIBER โฆ
๐
Analytical Method Development and Validation
โ Scribed by Michael E. Swartz (Editor); Ira S. Krull (Editor)
- Publisher
- CRC Press
- Year
- 1997
- Leaves
- 95
- Edition
- 1
- Category
- Library
โฌ Acquire This Volume
No coin nor oath required. For personal study only.
โฆ Synopsis
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
โฆ Table of Contents
Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.
โฆ Subjects
Physical Sciences;Chemistry;Analytical Chemistry
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