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Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies

Publication ,  Journal Article
Shah, VP; Midha, KK; Dighe, S; McGilveray, IJ; Skelly, JP; Yacobi, A; Layloff, T; Viswanathan, CT; Cook, CE; McDowall, RD; Pittman, KA; Spector, S
Published in: Journal of Pharmaceutical Sciences
January 1, 1992

This is a summary report of the conference on “Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies.” The conference was held from December 3 to 5, 1990, in the Washington, D.C., area and was sponsored by the American Association of Pharmaceutical Scientists, the U.S. Food and Drug Administration, Federation International Pharmaceutique, Health Protection Branch (Canada), and the Association of Official Analytical Chemists. The report presents our assessment of the major agreements and issues discussed at the conference. The report is also intended to provide guiding principles for validation of analytical methods used in bioavailability, bioequivaience, and pharmacokinetics studies in humans and animais. The objectives of the conference were as follows: (1) to reach a consensus on what should be required in analytical methods validation and the procedures to establish validation; (2) to determine processes of application of the validation procedures in bioavailability, bioequivalence, and pharmacokinetics studies; and (3) to develop a report on analytical methods validation that may be referred to in developing future formal guidelines. Acceptable standards for documenting and validating analytical methods with regard to processes, eters, or data treatments are discussed because of their importance in assessing pharmacokinetic, bioavailability, and bioequivalence studies. Other topics that were considered essential in the conduct of pharmacokinetic studies or in establishing bioequivalency criteria, including measurement of drug metabolites and stereoselective determinations, are also discussed. Copyright © 1992 Wiley‐Liss, Inc., A Wiley Company

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Published In

Journal of Pharmaceutical Sciences

DOI

EISSN

1520-6017

ISSN

0022-3549

Publication Date

January 1, 1992

Volume

81

Issue

3

Start / End Page

309 / 312

Related Subject Headings

  • Pharmacology & Pharmacy
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences
 

Citation

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Shah, V. P., Midha, K. K., Dighe, S., McGilveray, I. J., Skelly, J. P., Yacobi, A., … Spector, S. (1992). Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies. Journal of Pharmaceutical Sciences, 81(3), 309–312. https://doi.org/10.1002/jps.2600810324
Shah, V. P., K. K. Midha, S. Dighe, I. J. McGilveray, J. P. Skelly, A. Yacobi, T. Layloff, et al. “Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies.” Journal of Pharmaceutical Sciences 81, no. 3 (January 1, 1992): 309–12. https://doi.org/10.1002/jps.2600810324.
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies. Journal of Pharmaceutical Sciences. 1992 Jan 1;81(3):309–12.
Shah, V. P., et al. “Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies.” Journal of Pharmaceutical Sciences, vol. 81, no. 3, Jan. 1992, pp. 309–12. Scopus, doi:10.1002/jps.2600810324.
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S. Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies. Journal of Pharmaceutical Sciences. 1992 Jan 1;81(3):309–312.
Journal cover image

Published In

Journal of Pharmaceutical Sciences

DOI

EISSN

1520-6017

ISSN

0022-3549

Publication Date

January 1, 1992

Volume

81

Issue

3

Start / End Page

309 / 312

Related Subject Headings

  • Pharmacology & Pharmacy
  • 3214 Pharmacology and pharmaceutical sciences
  • 1115 Pharmacology and Pharmaceutical Sciences