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.
Achetez cet ebook et obtenez-en 1 de plus GRATUITEMENT !
Format PDF ● Pages 96 ● ISBN 9781482229776 ● Éditeur Michael E. Swartz ● Maison d’édition CRC Press ● Publié 2018 ● Téléchargeable 3 fois ● Devise EUR ● ID 6738219 ● Protection contre la copie Adobe DRM
Nécessite un lecteur de livre électronique compatible DRM