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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

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

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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.
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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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...
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Crop cultivation has a long history in human civilization, with records showing the cultivation of cereal plants beginning at around 8000 BC. This early plant breeding was developed primarily to provide a steady supply of food.
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Related Experiment Video

Updated: Dec 22, 2025

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Clarification on "EFSA Genetically Engineered Crop Composition Equivalence Approach: Performance and Consistency".

Rod A Herman1,2, Nicholas P Storer1, Carl Walker2

  • 1Corteva Agriscience, 9330 Zionsville Road, Indianapolis, Indiana 46268, United States.

Journal of Agricultural and Food Chemistry
|May 1, 2020
PubMed
Summary

The European Food Safety Authority's (EFSA) method for genetically engineered (GE) crops has low power to detect true equivalence, leading to inconsistent safety conclusions. Policy improvements are needed for better consumer protection regarding GE crop composition.

Keywords:
European Food Safety Authoritycompositional equivalencegenetically engineered cropsrisk assessment

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Area of Science:

  • Food safety assessment
  • Genetically engineered crops
  • Risk analysis

Background:

  • The European Food Safety Authority (EFSA) uses concurrently grown non-GE crops in risk assessments for GE varieties.
  • This approach aims to evaluate the compositional normality of GE crops.

Purpose of the Study:

  • To evaluate the EFSA's approach for assessing genetically engineered (GE) crops.
  • To identify limitations in detecting true compositional equivalence.

Main Methods:

  • Analysis of the statistical power of EFSA's comparative approach.
  • Review of the implications of comparator selection on safety conclusions.

Main Results:

  • EFSA's method, while managing the risk of false equivalence, suffers from low statistical power to detect true equivalence.
  • Inconsistent safety findings arise due to the choice of non-GE comparators for the same GE event.

Conclusions:

  • The current EFSA approach may not be optimal for ensuring robust safety conclusions for GE crops.
  • Policy adjustments are recommended to enhance consumer protection by better aligning risk assessment with compositional variation and safety.