Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Bioequivalence of Drugs: Drugs with Multiple Indications

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...

Bioequivalence: Overview

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...

Bioequivalence Data: Statistical Interpretation

Bioequivalence Data: Statistical Interpretation

The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

Equivalence: In Vitro and In Vivo Bioequivalence

Equivalence: In Vitro and In Vivo Bioequivalence

Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts. Pharmaceutical...

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Quantitative sensory testing in feline osteoarthritic pain - a systematic review and meta-analysis.

Osteoarthritis and cartilage·2020

Same author

Improving the estimation of amino acid requirements to maximize nitrogen retention in precision feeding for growing-finishing pigs.

Animal : an international journal of animal bioscience·2020

Same author

The bioequivalence of a single intravenous administration of the anesthetic alfaxalone in cyclodextrin versus alfaxalone in cyclodextrin plus preservatives in cats.

Journal of veterinary pharmacology and therapeutics·2018

Same author

Anticoagulant activity of oral rivaroxaban in healthy dogs.

Veterinary journal (London, England : 1997)·2017

Same author

Pharmacokinetics of liposomal encapsulated buprenorphine suspension following subcutaneous administration to cats.

Journal of veterinary pharmacology and therapeutics·2016

Same author

Genomic atolls of differentiation in coral reef fishes (Hypoplectrus spp., Serranidae).

Molecular ecology·2014

Search research articles

Related Experiment Video

Updated: May 24, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Demonstrating bioequivalence using clinical endpoint studies.

E Bermingham¹, J R E Del Castillo, C Lainesse

¹Division of Therapeutic Drugs for Non-Food Animals, FDA Center of Veterinary Medicine, Rockville, MD, USA. eden.bermingham@fda.hhs.gov

Journal of Veterinary Pharmacology and Therapeutics

|March 15, 2012

Summary

Clinical endpoint bioequivalence (BE) studies are less sensitive than blood level studies for drug formulation differences. This article explores alternative methods to improve bioequivalence assessment when blood studies are not feasible.

More Related Videos

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Fecal Glucocorticoid Analysis: Non-invasive Adrenal Monitoring in Equids

Fecal Glucocorticoid Analysis: Non-invasive Adrenal Monitoring in Equids

Published on: April 25, 2016

Related Experiment Videos

Last Updated: May 24, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Fecal Glucocorticoid Analysis: Non-invasive Adrenal Monitoring in Equids

Fecal Glucocorticoid Analysis: Non-invasive Adrenal Monitoring in Equids

Published on: April 25, 2016

Area of Science:

Pharmaceutical Sciences
Clinical Pharmacology
Regulatory Science

Background:

Clinical endpoint studies serve as an indirect measure of bioavailability for drug products unsuitable for blood level analysis.
These studies assess formulation differences between test and reference products but are less sensitive and present regulatory challenges.

Purpose of the Study:

To explore alternative methodologies and solutions for clinical endpoint bioequivalence (BE) studies.
To identify appropriate situations for clinical endpoint studies and discuss their limitations.

Main Methods:

Literature review and analysis of existing methodologies for bioequivalence studies.
Identification of challenges and advantages associated with clinical endpoint study designs.
Exploration of potential alternative solutions and future research directions.

Main Results:

Clinical endpoint studies are less sensitive than blood level studies in detecting formulation differences.
These studies pose significant challenges for regulatory authorities and sponsors.
Situations where clinical endpoint studies may be appropriate were identified.

Conclusions:

Future research is essential to develop novel methodologies for demonstrating bioequivalence.
Recommendations include exploring clinical trial simulations, advanced statistical methods, and innovative in vitro techniques.