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 of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

208
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...
208
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

382
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...
382
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.2K
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,...
2.2K
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

319
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...
319
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

327
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...
327
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

328
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
328

You might also read

Related Articles

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

Sort by
Same author

Visualization of liquid-liquid phase transitions using a tiny G-quadruplex binding protein.

bioRxiv : the preprint server for biology·2024
Same author

Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2023
Same author

Modeling immunogenecity data to establish screening bioassays cut point.

Pharmaceutical statistics·2023
Same author

RNA-seq data science: From raw data to effective interpretation.

Frontiers in genetics·2023
Same author

A comparison of statistical methods for animal oncology studies.

Pharmaceutical statistics·2022
Same author

A Bayesian Statistical Approach to Continuous Qualification of a Bioassay.

PDA journal of pharmaceutical science and technology·2020

Related Experiment Video

Updated: Mar 25, 2026

An In Vitro Caseum Binding Assay that Predicts Drug Penetration in Tuberculosis Lesions
12:17

An In Vitro Caseum Binding Assay that Predicts Drug Penetration in Tuberculosis Lesions

Published on: May 8, 2017

12.5K

A new PK equivalence test for a bridging study.

Steven J Novick1, Xiang Zhang2, Harry Yang1

  • 1a Statistical Sciences, MedImmune LLC , Gaithersburg , Maryland , USA.

Journal of Biopharmaceutical Statistics
|February 17, 2016
PubMed
Summary

This study introduces a new method for assessing drug bioequivalence by analyzing the maximum difference between plasma drug concentration profiles. This approach offers improved control over consumer risk compared to traditional pharmacokinetic parameter comparisons.

Keywords:
Bayesian posterior probabilitybioequivalenceconcentration–time curvepharmacokinetics

More Related Videos

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

18.3K
Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
10:02

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs

Published on: July 23, 2016

33.7K

Related Experiment Videos

Last Updated: Mar 25, 2026

An In Vitro Caseum Binding Assay that Predicts Drug Penetration in Tuberculosis Lesions
12:17

An In Vitro Caseum Binding Assay that Predicts Drug Penetration in Tuberculosis Lesions

Published on: May 8, 2017

12.5K
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

18.3K
Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
10:02

Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs

Published on: July 23, 2016

33.7K

Area of Science:

  • Pharmacokinetics
  • Bioequivalence Studies
  • Drug Formulation Analysis

Background:

  • Bioequivalence assessment typically relies on comparing pharmacokinetic (PK) parameters like AUC, Cmax, and T1/2.
  • Current methods may not fully capture the equivalence of the entire drug concentration-time profile.
  • Ensuring comparable bioavailability is crucial for drug product interchangeability.

Purpose of the Study:

  • To propose an alternative metric for assessing bioequivalence based on the maximum difference between PK profiles.
  • To develop a robust statistical test procedure for this new equivalence metric.
  • To enhance the control over consumer's risk in bioequivalence evaluations.

Main Methods:

  • Development of a novel equivalence metric focusing on the maximum difference between drug concentration-time profiles.
  • Implementation of a Bayesian analysis framework to account for model parameter uncertainties.
  • Validation through theoretical derivations and empirical simulations.

Main Results:

  • The proposed metric provides a more comprehensive assessment of bioequivalence than traditional PK parameter comparisons.
  • The Bayesian test procedure effectively controls for uncertainties in pharmacokinetic model parameters.
  • Simulations demonstrate superior control over consumer's risk with the new method.

Conclusions:

  • The novel maximum difference metric offers a more sensitive and reliable approach to bioequivalence testing.
  • Bayesian analysis enhances the statistical rigor and risk management in bioequivalence studies.
  • This method improves the assurance of therapeutic equivalence between drug formulations.