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Articles (19)

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1-10 of 19 results for Average bioequivalence

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Select article: Individual Variation and the Acceptance of Average Bioequivalence

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Research article

First published 1993-1

Individual Variation and the Acceptance of Average Bioequivalence

Laszlo Endrenyi, Miklos Schulz

Therapeutic Innovation & Regulatory Science

Select article: Some Conceptual Issues in the Evaluation of Average,Population,and Individual Bioequivalence

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Other

First published 2001-7

Some Conceptual Issues in the Evaluation of Average,Population,and Individual Bioequivalence

Volker W. Steinijans

Therapeutic Innovation & Regulatory Science

Select article: Methods to control the empirical type I error rate in average bioequivalence tests for highly variable drugs

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Research article

First published 2020-6

Methods to control the empirical type I error rate in average bioequivalence tests for highly variable drugs

Yuhao Deng, Xiao-Hua Zhou

Statistical Methods in Medical Research

Select article: International Harmonization of Regulatory Requirements for Average Bioequivalence and Current Issues in Individual Bioequivalence

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Research article

First published 1995-7

International Harmonization of Regulatory Requirements for Average Bioequivalence and Current Issues in Individual Bioequivalence

Volker W. Steinijans, Dieter Hauschke, Robert Schall

Therapeutic Innovation & Regulatory Science

Select article: Analysis of a Bioequivalence Trial Using Mixed Effects Modeling

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Research article

First published 1995-7

Analysis of a Bioequivalence Trial Using Mixed Effects Modeling

Nancy C. Sambol

Therapeutic Innovation & Regulatory Science

Select article: A Simple Three-Step Procedure for Parametric and Nonparametric Assessment of Bioequivalence

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Research article

First published 1997-1

A Simple Three-Step Procedure for Parametric and Nonparametric Assessment of Bioequivalence

Jouni Vuorinen, Jari Turunen

Therapeutic Innovation & Regulatory Science

Select article: Individual Bioequivalence—A Review of the FDA Draft Guidance

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Other

First published 1999-4

Individual Bioequivalence—A Review of the FDA Draft Guidance

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Select article: A Moment-Based Criterion for Determining Individual Bioequivalence

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Research article

First published 1995-7

A Moment-Based Criterion for Determining Individual Bioequivalence

Daniel J. Holder, Francis Hsuan

Therapeutic Innovation & Regulatory Science

Select article: Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration

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Research article

First published 2009-10

Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration

Barbara M Davit, Patrick E Nwakama, Gary J Buehler [...]

Annals of Pharmacotherapy

Select article: Bioequivalence of rimegepant,a small molecule CGRP receptor antagonist,administered as an oral tablet,a sublingual orally disintegrating tablet,and a supralingual orally disintegrating tablet: two phase 1 randomized studies in healthy adults

Open access

Research article

First published 2024-2

Bioequivalence of rimegepant,a small molecule CGRP receptor antagonist,administered as an oral tablet,a sublingual orally disintegrating tablet,and a supralingual orally disintegrating tablet: two phase 1 randomized studies in healthy adults

Robert Croop, Rajinder Bhardwaj, Matt S. Anderson [...]

Cephalalgia

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