References
- Brooks M. A., Weinfeld R. E. A validation process for data from the analysis of drugs in biological fluids. Drug Development and Industrial Pharmacy 1985; 11(9 & 10)1703–1728
- Buick A. R., Doig M. V., Seal S. C., Land G. S., McDowall R. D. Method validation in the bioanalytical laboratory. Journal of Pharmaceutical and Biomedical Analyses 1990; 8: 629–637
- Cartwright A. C., Gundert-Remy V., Rouws G., McGilveray I., Salmonson T., Walters S. International harmonization and consensus DIA meeting on bioavailability and bioequivalence testing requirements and standards. Drug Information Journal 1991; 25: 471–482
- Dadgar D., Smith M. R. Validation of chromatographic methods of analysis of drugs in biological samples. Trends in Analytical Chemistry 1986; 5: 115–117
- Inman E. L., Frishmann J. K., Jimenez P. J., Winkel G. D., Persinger M. L., Rotherford B. S. General method validation guidelines for pharmaceutical samples. Journal of Pharmaceutical Sciences 1987; 25: 252–256
- MacDouglas D., Crummet W. Guidelines for data acquisition and data quality evaluation in environmental chemistry. Analytical Chemistry 1980; 52: 2242–2249
- Pachla L. A., Wright D. S., Reynolds D. L. Bioanalytical considerations for pharmacokinetics and biopharmaceutic studies. Journal of Clinical Pharmacology 1986; 26: 332–335
- Shah V. P. Analytical methods used in bioavailability studies. A regulatory viewpoint. Clinical Research Practices and Drug Regulatory Affairs 1987; 5: 51–60
- Shah V. P., Midha K. K., Dighe S., McGilveray I. J., Skelly J. P., Layloff T., Viswanathan C. T., Yacokb A. (1990) Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference Report,Washington, DC,December, 3–51991
- Taylor J. K. Validation of analytical methods. Analytical Chemistry 1983; 55: 601–608