共 50 条
- [5] The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation AAPS JOURNAL, 2007, 9 (01): : E43 - E47
- [10] Validation issues arising from the new FDA guidance for industry on bioanalytical method validation Chromatographia, 2002, 55 : S91 - S94