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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

2.1K
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,...
2.1K
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

203
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...
203
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

356
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...
356
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

235
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
235
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

307
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...
307
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

238
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.
238

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Related Experiment Video

Updated: Mar 7, 2026

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Bioequivalence Demonstration for Ω-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance.

Kevin C Maki1, Colleen Johns2, William S Harris3

  • 1Midwest Biomedical Research/Center for Metabolic and Cardiovascular Research and Department of Food Science and Nutrition, Illinois Institute of Technology, Chicago, Illinois.

Clinical Therapeutics
|February 13, 2017
PubMed
Summary

The FDA should harmonize bioequivalence testing for omega-3 acid ethyl esters. Using plasma lipids for both fasting and fed states is more physiologically rational for these pro-drugs.

Keywords:
bioequivalencedocosahexaenoic acideicosapentaenoic acidethyl esters ω-3 fatty acidstriglycerides

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Biochemistry
  • Regulatory Science

Background:

  • The US FDA recommends separate bioequivalence (BE) studies for omega-3 acid ethyl esters in fasting and fed states.
  • Current FDA draft guidance for omega-3 acid ethyl esters differs from that for icosapent ethyl.
  • Omega-3 acid ethyl esters are physiologically best characterized as pro-drugs.

Purpose of the Study:

  • To propose an amendment to the FDA draft guidance for omega-3 acid ethyl esters.
  • To advocate for harmonized bioequivalence testing across omega-3 products.
  • To align BE testing with the pro-drug nature of EPA and DHA ethyl esters.

Main Methods:

  • Review of current FDA draft guidance for omega-3 acid ethyl esters.
  • Comparison with established guidance for icosapent ethyl.
  • Physiological rationale for pro-drug characteristics of EPA and DHA ethyl esters.

Main Results:

  • The FDA draft guidance recommends different primary BE measures for fasting (total plasma lipids) and fed (plasma ethyl esters) states for omega-3 acid ethyl esters.
  • This differs from icosapent ethyl, where total plasma lipids are used for both states.
  • The current guidance is not fully supported by the pro-drug nature of omega-3 acid ethyl esters.

Conclusions:

  • Amending FDA guidance to use baseline-adjusted EPA and DHA in total plasma lipids for both fasting and fed conditions is recommended.
  • This proposed change would harmonize BE testing for omega-3 acid ethyl esters and icosapent ethyl.
  • The suggested approach aligns with the physiological characteristics and triglyceride-lowering mechanisms of these compounds.