1st Edition
Analytical Method Development and Validation
96 Pages
by
CRC Press
96 Pages
by
CRC Press
96 Pages
by
CRC Press
Also available as eBook on:
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... Read more
Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.
Biography
Michael E. Swartz, Ira S. Krull
". . .a useful primer-type book covering validation of analytical methods. . . .recommended."
---Analyst
"Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions."
---INFORM
