1. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S (1992) Pharm Res 9(4):588–592
2. Food and Drug Administration (1999) Draft Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, US Food and Drug Administration, Center for Drug Evaluation and Research
3. Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A (2000) Pharm Res 17(12):1551–1557
4. Food and Drug Administration (2001) Guidance for Industry: Bioanalytical method validation. US Food and Drug Administration, Center for Drug Evaluation and Research, Rockville
5. Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R (2007) AAPS J 9(1):E30–E42