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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… 
National Institutes of Health

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Related topics

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CDISC SDTM Trial Type TerminologyClinical Data Interchange Standards Consortium Terminology

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Review
2015
Review
2015
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine.
Literature data relevant to the biopharmaceutical properties of the active pharmaceutical ingredient (API) nifedipine are… 
2013
2013
Quantitative assessment of the switchability of generic products.
2012
2012
Use of Partial AUC (PAUC) to Evaluate Bioequivalence—A Case Study with Complex Absorption: Methylphenidate
Methylphenidate modified-release products produce early and late peak concentrations critical for treatment of morning and… 
2011
2011
Study on dissolution and absorption of four dosage forms of isosorbide mononitrate: level A in vitro-in vivo correlation.
2010
2010
Examining the role of metabolites in bioequivalence assessment.
PURPOSE Investigate the role of metabolites in bioequivalence (BE) assessment. METHODS. Sets of ordinary differential equations… 
Highly Cited
2003
Highly Cited
2003
Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products
AbstractPurpose. To provide a rational procedure for establishing regulatory bioequivalence (BE) limits that can be applied in… 
2003
2003
Scaling or wider bioequivalence limits for highly variable drugs and for the special case of C(max).
OBJECTIVE To illustrate that bioequivalence (BE) can be effectively evaluated for highly variable (HV) drugs and drug products… 
2003
2003
Pharmacodynamic considerations in bioequivalence assessment: comparison of novel and existing metrics.
2002
2002
A practical approach for comparing means of two groups without equal variance assumption
In this paper we consider two‐groups of i.i.d. normally distributed random variables (N(μx,σx2) and N(μy,σy2)) without assuming… 
1994
1994
Comparison of Single and Multiple Dose Pharmacokinetics Using Clinical Bioequivalence Data and Monte Carlo Simulations
The purpose of this study was to evaluate the relative performance and usefulness of single dose (SD) and multiple dose (MD… 
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