Analytical Method Development And Validation
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Analytical Method Development and Validation
| Author | : Michael E. Swartz |
| Publisher | : CRC Press |
| Total Pages | : 95 |
| Release | : 2018-10-03 |
| Genre | : Science |
| ISBN | : 1482229773 |
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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.
