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Articles (27)

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1-10 of 27 results for Population bioequivalence

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

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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: Exploratory and Population Pharmacodynamic Analysis of Pilot Dose-Response Data in the Bioequivalence Testing of Topical Corticosteroid Preparations

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First published 1997-10

Exploratory and Population Pharmacodynamic Analysis of Pilot Dose-Response Data in the Bioequivalence Testing of Topical Corticosteroid Preparations

Laszlo Endrenyi, Min Gao, Yong Hao

Therapeutic Innovation & Regulatory Science

Select article: Recent Statistical Developments in Bioequivalence Trials — A Review of the FDA Guidance*

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Research article

First published 1994-7

Recent Statistical Developments in Bioequivalence Trials — A Review of the FDA Guidance*

Shein-Chung Chow, Jen-Pei Liu

Therapeutic Innovation & Regulatory Science

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: Sample Size Estimation for the U.S. Food and Drug Administration's In Vitro Population Bioequivalence Test of DPIs,MDIs,Nasal Sprays,and Nebules

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Research article

First published 2018-04

Sample Size Estimation for the U.S. Food and Drug Administration's In Vitro Population Bioequivalence Test of DPIs,MDIs,Nasal Sprays,and Nebules

Anders Fuglsang

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Select article: Individual Bioequivalence—A Review of the FDA Draft Guidance

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First published 1999-4

Individual Bioequivalence—A Review of the FDA Draft Guidance

Shein-Chung Chow

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: Replicated Crossover Designs in Bioavailability and Bioequivalence Trials *

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First published 1995-7

Replicated Crossover Designs in Bioavailability and Bioequivalence Trials *

Jen-Pei Liu, Shein-Chung Chow

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: Current Issues in Bioequivalence Trials

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Research article

First published 1995-7

Current Issues in Bioequivalence Trials

Shein-Chung Chow, Jen-Pei Liu

Therapeutic Innovation & Regulatory Science

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