Therapeutic Equivalency Study

Known as: BIO-EQUIVALENCE 
A study most often used to compare the efficacy of different formulations to treat a given disease. It is the testing of an old versus a new… (More)
National Institutes of Health

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CDISC SDTM Trial Type TerminologyClinical Data Interchange Standards Consortium Terminology

Papers overview

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2012
2012
KinetDS : An Open Source Software for Dissolution Test Data Analysis
Because drug quality is the focus for pharmaceutical industry and regulatory agencies, the in vitro dissolution test becomes a… (More)
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2010
2010
Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System.
AIM The aim of this study was to evaluate the acceptability of 124 bioequivalence (BE) studies with 80 active substances… (More)
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2008
2008
Development of Discriminating Method for Dissolution of Aceclofenac Marketed Formulations
The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to the… (More)
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2007
2007
Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method.
The aim of this study was to evaluate the relationship between dermal microdialysis (DMD) sampling and the dermatopharmacokinetic… (More)
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Highly Cited
2006
Highly Cited
2006
A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan.
Orally administered, immediate-release (IR) drug products in the top 200 drug product lists from the United States (US), Great… (More)
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Highly Cited
2006
Highly Cited
2006
The suitability of an in situ perfusion model for permeability determinations: utility for BCS class I biowaiver requests.
The FDA has published recommendations for sponsors who wish to request a waiver of in vivo bioavailability (BA) or bioequivalence… (More)
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Highly Cited
2004
Highly Cited
2004
Molecular properties of WHO essential drugs and provisional biopharmaceutical classification.
The purpose of this study is to provisionally classify, based on the Biopharmaceutics Classification System (BCS), drugs in… (More)
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Review
2004
Review
2004
Drug delivery to the nasal cavity: in vitro and in vivo assessment.
Drugs are given intranasally for both local and systemic applications, and the use of the intranasal route is predicted to rise… (More)
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2003
2003
Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products
Purpose. To provide a rational procedure for establishing regulatory bioequivalence (BE) limits that can be applied in… (More)
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2001
2001
Evaluation of the Bioequivalence of Highly-Variable Drugs and Drug Products
Purpose. To establish procedures for the effective evaluation of bioequivalence (BE) for highly-variable drugs and drug products… (More)
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