References

1. Guidance for Industry: Bioanalytical Method Validation 2001. www.fda.gov/ cder/guidance/index.htm

2. Shah, V.P.; Midha, K.K.; Dighe, S.; McGilveray, J.J.; Skelly, J.P.; Yacobi, A.; Layloff, T.; Viswanathan, C.T.; Cook, C.E.; McDowell, R.D.; Pittman, K.A.; Spector, S. Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. Pharm. Res. 1992, 9, 588-592.

3. Guidance for Industry: Bioanalytical Method Validation in Human Studies Posted in 1999. www.fda.gov/cder/guidance/index.htm

4. Shah, V.P.; Midha, K.K.; Findlay, J.W. A.; Hill, H.M.; Hulse, J.D.; MacGilveray, I.J.; McKay, G.; Miller, K.J.; Patnaik, R.N.; Powell, M.L.; Tonelli, A.; Viswanathan, C.T.; Yacobi, A. Workshop/Conference Report Bioanalytical Method Validation—a Revisit with a Decade of Progress Pharm Res 2000, 17, 1551-1557.

5. Guidance for Industry: Analytical Procedures and Methods Validation Chemistry, Manufacturing and Controls Documentation, www.fda.gov/cder/ guidance/index.htm

6. Reviewer Guidance: Validation of Chromatographic Methods, www.fda.gov/ cder/guidance/index.htm

7. Guideline for Submitting Samples and Analytical Data for Methods Valida-tion. www.fda.gov/cder/guidance/index.htm

8. Jennings, W. Analytical Gas Chromatograpgy. Academic Press: San Diego, 1987; pp. 1-23.

9. Causon, R. Validation of Chromatographic Methods in Biomedical Analysis: Viewpoint and Discussion. J. Chromatog. B 1997, 689, 175-180.

10. ICH Topic Q2B: Validation of Analytical Procedures: Methodology, www.eudra.org/emea.html

11. Oldfield, P.R.; Pham, K.; Ng, A. The Effect of Prozone on Toxicokinetic Data— a Case Study. American Association of Pharmaceutical Scientists Annual Meeting, 2000 Abstract 3182.

12. Code of Federal Regulations, Title 21 parts 320, 2000, 185-199.

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