DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS

Autor: Thomas, Hoffelder, David, Leblond, Leslie, Van Alstine, Dorys Argelia, Diaz, Sandra, Suarez-Sharp, Krista, Witkowski, Stan, Altan, James, Reynolds, Zachary, Bergeron, Kevin, Lief, Yanbing, Zheng, Andreas, Abend
Rok vydání: 2021
Předmět:
Zdroj: The AAPS journal. 24(3)
ISSN: 1550-7416
Popis: The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product decisions as part of drug product life cycle management. Accordingly, the application of mathematical approaches to evaluate dissolution profile similarity is described in regulatory guidance with the emphasis given to the similarity factor f
Databáze: OpenAIRE