The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington Conference to the laboratory

Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Journal of Pharmaceutical Sciences · 1992 · 1.1K citations

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +14

Reappraisal of Hypothesis Testing for Method Validation: Detection of Systematic Error by Comparing the Means of Two Methods or of Two Laboratories

Christa Hartmann, J. Smeyers–Verbeke, W. Penninckx et al. · Analytical Chemistry · 1995 · 147 citations

Pharmacy, Biostatistics, Analytical Chemistry +16

Precision, Accuracy, and Data Acceptance Criteria in Biopharmaceutical Analysis

H. Thomas Karnes, Clark March · Pharmaceutical Research · 1993 · 147 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutics +14

Method validation in the bioanalytical laboratory

A.R. Buick, Mira Doig, S. Jeal et al. · Journal of Pharmaceutical and Biomedical Analysis · 1990 · 146 citations

Pharmacy, Biochemistry, Chemistry +13

Calibration and validation of linearity in chromatographic biopharmaceutical analysis

H. Thomas Karnes, Clark March · Journal of Pharmaceutical and Biomedical Analysis · 1991 · 96 citations

Pharmacy, Pharmaceutical Analysis, Pharmacology +12