Analytical Method Development and Validation
Download or Read eBook Analytical Method Development and Validation PDF written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle.
| Author | : Michael E. Swartz |
| Publisher | : CRC Press |
| Total Pages | : 95 |
| Release | : 2018-10-03 |
| ISBN-10 | : 9781482229776 |
| ISBN-13 | : 1482229773 |
| Rating | : 4/5 (76 Downloads) |
Book Synopsis Analytical Method Development and Validation by : Michael E. Swartz
Book excerpt: 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.
