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

Papers overview

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2012
2012
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
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
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
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
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 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
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
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
Purpose. To provide a rational procedure for establishing regulatory bioequivalence (BE) limits that can be applied in… (More)
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2001
2001
Purpose. To establish procedures for the effective evaluation of bioequivalence (BE) for highly-variable drugs and drug products… (More)
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