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

Equivalence: In Vitro and In Vivo Bioequivalence

Equivalence: In Vitro and In Vivo Bioequivalence

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.

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

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...

Bioequivalence Data: Statistical Interpretation

Bioequivalence Data: Statistical Interpretation

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...

Pharmaceutical Equivalents

Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.

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...

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,...

You might also read

Related Articles

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

Sort by

Same author

Evidence of chaotic dynamics underlying the human alpha-rhythm electroencephalogram.

Biological cybernetics·1989

Same author

Physical models of biological information and adaptation.

Journal of theoretical biology·1985

Same author

On the stability and non-local properties of memory.

Journal of theoretical biology·1978

See all related articles

Search research articles

Related Experiment Video

Updated: Nov 3, 2025

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Published on: August 4, 2023

Bio-informational equivalence.

Journal of Theoretical Biology

|April 21, 1985

Summary

Modern genetics and evolutionary biology concepts are merging with bio-informational equivalence. This paper argues that bio-informational equivalence is anthropocentric and unsuitable for biological science.

Area of Science:

Biology
Genetics
Evolutionary Biology

Background:

Modern genetics and evolutionary processes are foundational to biological science.
Over the last 30 years, these concepts have integrated with the idea of biological processes as information transactions, termed bio-informational equivalence.

Purpose of the Study:

To analyze the concept of bio-informational equivalence.
To critically evaluate its suitability as a quasi-theoretical perspective in biological science.

Main Methods:

Conceptual analysis of bio-informational equivalence.
Examination of its core assumptions and implications.

Main Results:

Bio-informational equivalence manifests in three basic forms or combinations thereof.

More Related Videos

Biological Compatibility Profile on Biomaterials for Bone Regeneration

Published on: November 16, 2018

Quantification of Information Encoded by Gene Expression Levels During Lifespan Modulation Under Broad-range Dietary Restriction in C. elegans

Quantification of Information Encoded by Gene Expression Levels During Lifespan Modulation Under Broad-range Dietary Restriction in C. elegans

Published on: August 16, 2017

Related Experiment Videos

Last Updated: Nov 3, 2025

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research

Published on: August 4, 2023

Biological Compatibility Profile on Biomaterials for Bone Regeneration

Published on: November 16, 2018

Quantification of Information Encoded by Gene Expression Levels During Lifespan Modulation Under Broad-range Dietary Restriction in C. elegans

Quantification of Information Encoded by Gene Expression Levels During Lifespan Modulation Under Broad-range Dietary Restriction in C. elegans

Published on: August 16, 2017

The concept possesses a fundamentally anthropocentric core.

Conclusions:

The anthropocentric nature of bio-informational equivalence makes it ill-suited for its current role in biological science.
Re-evaluation of this perspective is necessary for advancing biological understanding.