Modified-Release Dosage Forms: Acceptance Criteria and Statistics for Bioequivalence

A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

1987 • 2,396 citations

Biopharmaceutical Statistics for Drug Development.

1989 • 314 citations

A distribution-free procedure for the statistical analysis of bioequivalence studies.

1992 • 224 citations

Sample size determination for bioequivalence assessment by means of confidence intervals.

1991 • 221 citations

Design and Analysis of Bioavailability and Bioequivalence Studies.

1994 • 205 citations

Power of the two one-sided tests procedure in bioequivalence

1990 • 143 citations

Design and Analysis of Bioavailability and Bioequivalence Studies

1993 • 139 citations

Sample size determination for bioequivalence assessment using a multiplicative model

1992 • 86 citations

Types of bioequivalence and related statistical considerations.

1992 • 80 citations

Presentation of results from bioequivalence studies.

1992 • 70 citations

Controversies in Bioequivalence Studies

1992 • 67 citations

Pharmacokinetic characterization of controlled-release formulations

1990 • 55 citations

Theophylline Steady-State Pharmacokinetics: Recent Concepts and Their Application in Chronotherapy of Reactive Airway Diseases

1987 • 23 citations

Effect of changing the bioequivalence range from (0.80, 1.20) to (0.80, 1.25) on the power and sample size.

1992 • 13 citations