Bioequivalence

Bioequivalence is a pharmaceutical equivalence criterion based on the absence of a statistically significant difference between two drug formulations in the rate and extent of active pharmaceutical ingredient bioavailability at the site of drug action.

1.9K

Publications

69.9K

Citations

7.1K

Authors

1.9K

Institutions

Publications per year

2017–2026

286

Variants

Bioequivalence Studies

Parents

Clinical Pharmacokinetics

Children

Bioanalytical Method ValidationBioequivalence Acceptance CriteriaBioequivalence Study DesignBiopharmaceutics Classification SystemFed Bioequivalence StudiesGeneric Drug EvaluationHighly Variable Drug ProductsIn Vitro CorrelationIn Vivo CorrelationMultiple-dose Bioequivalence Studies

Publications

1.9K

A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

Donald J. Schuirmann · Journal of Pharmacokinetics and Biopharmaceutics · 1987 · 2.6K citations · Full text

Pharmacy, Biostatistics, Bioavailability +10

Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Journal of Pharmaceutical Sciences · 1992 · 1.1K citations

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +14

Equivalence of the insulin sensitivity index in man derived by the minimal model method and the euglycemic glucose clamp.

Richard N. Bergman, Rudolf Prager, Jerrold M. Olefsky · Journal of Clinical Investigation · 1987 · 779 citations · Full text

Medicine, Endocrinology, Physiology +9

Characterization of the Human Upper Gastrointestinal Contents Under Conditions Simulating Bioavailability/Bioequivalence Studies

Lida Kalantzi, Konstantinos Goumas, V. Kalioras et al. · Pharmaceutical Research · 2005 · 653 citations

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +14

Bioavailability -- A Problem in Equivalence

Carl M. Metzler · Biometrics · 1974 · 638 citations

Pharmacy, Biostatistics, Pharmacology +10

1–5 of 1.9K

Authors

7.1K

SC
Shein‐Chung Chow
Duke University, United States
39 publications · 1.4K citations
23
h-index
LE
László Endrényi
University of Toronto, Canada
34 publications · 980 citations
20
h-index
VP
Vinod P. Shah
Center for Drug Evaluation and Research, United States
23 publications · 3.4K citations
18
h-index
WW
Walter W. Hauck
Thomas Jefferson University, United States
23 publications · 1.7K citations
18
h-index
LT
László Tóthfalusi
Semmelweis University, Hungary
18 publications · 533 citations
15
h-index

1–5 of 7.1K

Institutions

1.9K

1–8 of 1.9K

Venues

Pharmaceutical Research
68 publications · 4K citations
35
h-index
PubMed
Repository · 129 publications · 3.7K citations
32
h-index
The Journal of Clinical Pharmacology
81 publications · 2.6K citations
30
h-index
Clinical Pharmacology & Therapeutics
CPT · 39 publications · 1.6K citations
24
h-index
Journal of Pharmaceutical Sciences
45 publications · 2.9K citations
24
h-index

1–5

See also Bioequivalence
Evaluation	Confidence Intervals Physiologically Based Pharmacokinetic Modeling Computational Fluid Dynamics Model-independent Pharmacokinetics In Vitro-in Vivo Correlation Physiologically Based Biopharmaceutics Modeling Skin Permeability Testing Area Under The Curve Type I Error Rate
Core Methods	Pharmacokinetics Statistical Analysis Real-world Evidence Machine Learning In Vitro-in Vivo Correlation Clinical Data Management
Regulatory Standards	Biopharmaceutics Classification System Regulatory Bioequivalence Guidance
Applications	Generic Modified-release Product Development Access To Biosimilars Market Authorization Renewal
Limitations	Regulatory Network Heterogeneity Type I Error Rate Model Validation Analysis Of Biological Variability In Vitro-in Vivo Correlation