Analytical Method Development and Validation

ISBN-13: 9781138402560 / Angielski / Twarda / 2017

Swartz, Michael E.

Opis

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.

Recenzje

". . .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

Spis treści

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

O autorze

Michael E. Swartz, Ira S. Krull