International Harmonization of Regulatory Bioequivalence Requirements

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

1987 • 2,396 citations

15 Design and Analysis of Cross-Over Trials

2007 • 877 citations

Design and Analysis of Cross-Over Trials

1989 • 630 citations

Design and Analysis of Bioavailability and Bioequivalence Studies

1994 • 503 citations

Symmetrical Confidence Intervals for Bioequivalence Trials

1976 • 341 citations

Consideration of individual bioequivalence

1990 • 250 citations

A new procedure for testing equivalence in comparative bioavailability and other clinical trials

1983 • 245 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

Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence.

1991 • 132 citations

Food-induced changes in theophylline absorption from controlled-release formulations. Part I. Substantial increased and decreased absorption with Uniphyl tablets and Theo-Dur Sprinkle

1985 • 101 citations

Lack of pharmacokinetic interaction as an equivalence problem.

1991 • 90 citations

Pharmacokinetic criteria for the evaluation of retard formulations

1974 • 86 citations

Sample size determination for bioequivalence assessment using a multiplicative model

1992 • 86 citations

Types of bioequivalence and related statistical considerations.

1992 • 80 citations

Update on the statistical analysis of bioequivalence studies.

1990 • 76 citations

Presentation of results from bioequivalence studies.

1992 • 70 citations

Controversies in Bioequivalence Studies

1992 • 67 citations

The Subject-by-Formulation Interaction as a Criterion of Interchangeability of Drugs

1989 • 64 citations

Food Interactions with Sustained-Release Theophylline Preparations1

1989 • 58 citations

Pharmacokinetic characterization of controlled-release formulations

1990 • 55 citations

Report of the Workshop on In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms

1990 • 53 citations

Striving for standards in bioequivalence assessment: a review.

1991 • 51 citations

International Harmonization and Consensus DIA Meeting on Bioavailability and Bioequivalence Testing Requirements and Standards

1991 • 51 citations

A new in vitro dissolution test for controlled-release theophylline tablets

1981 • 36 citations

Design of Bioavailability/Bioequivalence Studies

1990 • 35 citations

Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.

1992 • 33 citations

Consensus Report from “Bio International ’89”: Issues in the Evaluation of Bioavailability Data

1990 • 31 citations

Pharmacokinetic determinants in the design and evaluation of sustained-release dosage forms.

1984 • 29 citations

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

1987 • 23 citations

Bioequivalence studies: single vs multiple dose.

1989 • 19 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

Galenical development of a new sustained-release theophylline pellet formulation for once-daily administration.

1988 • 11 citations

A novel approach to the specification of in-vitro dissolution boundaries based on regulatory requirements for bioequivalence.

1988 • 11 citations

Effect of drug intake prior to or after meals on serum theophylline concentrations: single-dose studies with Euphylong.

1987 • 11 citations

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

1993 • 6 citations

Controlled/Modified Release Products. Von H. Blume, U. Gundert‐Remy, H. Möller, Wissenschaftl. Verlagsges. mbH, Stgt., 1991, 220 S., 72 Abb., 41 Tabellen, Paperback APV Bd. 29, DM 82.–

1992 • 1 citations

Deleted Work

1955 • 0 citations