Analytical Method Development and Validation

Autor:	Michael E. Swartz, Ira S. Krull
Rok vydání:	2018
Předmět:	Food and drug administration Risk analysis (engineering) Computer science Method development High-performance liquid chromatography health care economics and organizations
DOI:	10.1201/9781315275161
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::48729746459544cb5305ce443e0a0b68 https://doi.org/10.1201/9781315275161 Zobrazit plný text záznamu