A strategy for validation of bioanalytical methods.

[1]  D L Massart,et al.  An analysis of the Washington Conference Report on bioanalytical method validation. , 1994, Journal of pharmaceutical and biomedical analysis.

[2]  S. Bolton,et al.  A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry--1. Experimental considerations. , 1991, Journal of pharmaceutical and biomedical analysis.

[3]  J. Barbet,et al.  Quantitation of adriamycin in plasma and urine: comparative study of radioimmunoassay and high-performance liquid chromatography methods. , 1983, Journal of pharmaceutical and biomedical analysis.

[4]  Thomas Layloff,et al.  Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies , 1992 .

[5]  E. Jensen,et al.  Chiral drugs: an industrial analytical perspective. , 1991, Journal of pharmaceutical and biomedical analysis.

[6]  C. Hsu,et al.  Chiral assay methods for lifibrol and metabolites in plasma and the observation of unidirectional chiral inversion following administration of the enantiomers to dogs. , 1994, Chirality.

[7]  S. Bolton,et al.  A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry--2. Statistical analyses. , 1991, Journal of pharmaceutical and biomedical analysis.

[8]  R. McDowall,et al.  Method validation in the bioanalytical laboratory. , 1990, Journal of pharmaceutical and biomedical analysis.

[9]  C. T. Viswanathan,et al.  Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development , 1992, Clinical pharmacology and therapeutics.

[10]  I. Wainer,et al.  Enantioselective determination of hydroxychloroquine and its major metabolites in urine and the observation of a reversal in the (+)/(-)-hydroxychloroquine ratio. , 1993, Chirality.

[11]  L. Phillips,et al.  Evaluation of criteria for the acceptance of bioanalytical data. , 1990, Journal of pharmaceutical and biomedical analysis.

[12]  A. Cartwright.  International Harmonization and Consensus DIA Meeting on Bioavailability and Bioequivalence Testing Requirements and Standards , 1991 .