Author:
Booth Brian,Arnold Mark E.,DeSilva Binodh,Amaravadi Lakshmi,Dudal Sherri,Fluhler Eric,Gorovits Boris,Haidar Sam H.,Kadavil John,Lowes Steve,Nicholson Robert,Rock Marie,Skelly Michael,Stevenson Lauren,Subramaniam Sriram,Weiner Russell,Woolf Eric
Publisher
Springer Science and Business Media LLC
Reference24 articles.
1. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm Res. 1992;9(4):588–92.
2. Conduct and analysis of bioavailability and bioequivalence studies—Part A: Oral dosage formulations. [book auth.] Health Canada. s.l. : Ministry of Health, Heath Products and Food Branch. Canada. 1992.
3. Food and Drug Administration, USA. Guidance for industry bioanalytical method validation. [Online] May 2001. http://www.fda.gov/cder/guidance/index.htm .
4. Guide for validation of analytical and bioanalytical methods, Resolution - RE n. 899, of May 29, 2003, Agência Nacional de Vigilância Sanitária www.anvisa.gov.br .
5. EMA, European Medicines Agency. Guideline on bioanalytical method validation. [Online] July 21, 2011. EMEA/CHMP/EWP/192217/2009.
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