Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

110
Body: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...
110
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

111
Body: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...
111
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

126
Body: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.
126
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

126
Body: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...
126
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

92
Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
92
Bioequivalence: Overview01:16

Bioequivalence: Overview

1.5K
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,...
1.5K

You might also read

Related Articles

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

Sort by
Same author

Divide and summarize: improve SLM text summarization.

Frontiers in artificial intelligence·2025
Same author

Growth charts for small sample sizes using unsupervised clustering: Application to canine early growth.

Veterinary research communications·2022
Same author

Case Report: True Motor Recovery of Upper Limb Beyond 5 Years Post-stroke.

Frontiers in neurology·2022
Same author

T1/T2 ratio: A quantitative sensitive marker of brain tissue integrity in multiple sclerosis.

Journal of neuroimaging : official journal of the American Society of Neuroimaging·2021
Same author

Signal Intensity Evaluation in the Dentate Nucleus and Subcortical Gray Matter : Effect of Several Administrations of Gadoterate Meglumine in Multiple Sclerosis.

Clinical neuroradiology·2021
Same author

White matter microarchitecture and structural network integrity correlate with children intelligence quotient.

Scientific reports·2020

Related Experiment Video

Updated: Dec 9, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.1K

Between-Batch Bioequivalence (BBE): a Statistical Test to Evaluate In Vitro Bioequivalence Considering the

Jonathan Bodin1, Stéphanie Liandrat2, Gabriel Kocevar1

  • 1Data Science Department, Seenovate, Lyon, France.

The AAPS Journal
|September 10, 2020
PubMed
Summary

This study introduces between-batch bioequivalence (BBE), a novel method for generic drug development. BBE offers a more efficient alternative to current average bioequivalence (ABE) and population bioequivalence (PBE) tests, especially when batch variability is significant.

Keywords:
between-batch variabilityequivalence testin vitro bioequivalencenasal spraystatistical test

More Related Videos

In Vitro Enzyme Measurement to Test Pharmacological Chaperone Responsiveness in Fabry and Pompe Disease
10:16

In Vitro Enzyme Measurement to Test Pharmacological Chaperone Responsiveness in Fabry and Pompe Disease

Published on: December 20, 2017

8.4K
Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader
09:15

Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader

Published on: July 27, 2022

2.4K

Related Experiment Videos

Last Updated: Dec 9, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

18.1K
In Vitro Enzyme Measurement to Test Pharmacological Chaperone Responsiveness in Fabry and Pompe Disease
10:16

In Vitro Enzyme Measurement to Test Pharmacological Chaperone Responsiveness in Fabry and Pompe Disease

Published on: December 20, 2017

8.4K
Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader
09:15

Enhanced Reproducibility and Precision of High-Throughput Quantification of Bacterial Growth Data Using a Microplate Reader

Published on: July 27, 2022

2.4K

Area of Science:

  • Pharmacokinetics and Drug Development
  • Regulatory Science
  • Statistical Methods in Pharmaceutical Research

Background:

  • Bioequivalence testing is crucial for generic drug approval but lacks global consensus.
  • Current methods like average bioequivalence (ABE) and population bioequivalence (PBE) have limitations, particularly with non-negligible batch variability.
  • These limitations can necessitate larger sample sizes, increasing development costs and time.

Purpose of the Study:

  • To propose and evaluate a novel bioequivalence testing method: between-batch bioequivalence (BBE).
  • To assess the performance of BBE compared to ABE and PBE using simulations and real-world case studies.
  • To demonstrate BBE's potential to improve efficiency and reduce costs in generic drug development.

Main Methods:

  • Theoretical framework development for between-batch bioequivalence (BBE).
  • Simulation studies to evaluate BBE's performance, including false positive and false negative rates.
  • Application of BBE to real-world case studies, specifically a nasal spray product.
  • Comparison of BBE with existing average bioequivalence (ABE) and population bioequivalence (PBE) methods.

Main Results:

  • BBE demonstrated high performance in simulations, with accurate estimations of type I and type II errors.
  • BBE showed significantly higher true positive rates than ABE and PBE when the Reference residual standard deviation exceeded 15%.
  • Real-case applications confirmed BBE's greater efficiency in demonstrating equivalence for products with non-negligible batch variability.

Conclusions:

  • Between-batch bioequivalence (BBE) is a promising alternative to current bioequivalence testing methods.
  • BBE is particularly advantageous when batch variability is a significant factor.
  • Adoption of BBE could lead to more cost-effective and efficient generic drug development.