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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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Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

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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...
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Modified-Release Drug Delivery Systems: Bioavailability01:30

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Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
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Bioequivalence studies: Biowaivers01:13

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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...
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Bioavailability: Overview01:17

Bioavailability: Overview

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Bioavailability refers to the proportion of an administered drug that reaches the systemic circulation in its active, unaltered form. It is a crucial pharmacokinetic parameter that determines the effectiveness of a drug in achieving its intended therapeutic outcomes. The route of administration significantly influences bioavailability, with intravenous administration achieving 100% bioavailability as the drug directly enters the bloodstream. In contrast, oral administration often results in...
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Bioavailability: Overview01:13

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Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
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Bioavailability and Bioequivalence in Drug Development.

Shein-Chung Chow1

  • 1Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA.

Wiley Interdisciplinary Reviews. Computational Statistics
|September 13, 2014
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Summary
This summary is machine-generated.

This article explains bioavailability and bioequivalence, crucial for generic drug approval in the U.S. It covers regulatory requirements and assessment methods for ensuring drug absorption and clinical outcomes.

Keywords:
Drug interchangeabilityFundamental Bioequivalence AssumptionHighly variable drugsScaled average bioequivalence (SABE) criterion

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Regulatory Science
  • Pharmaceutical Sciences

Background:

  • Bioavailability defines drug absorption rate and extent, predicting clinical outcomes.
  • The U.S. FDA approves generic drugs based on bioequivalence studies since 1984.
  • Understanding bioavailability and bioequivalence is vital for generic drug efficacy.

Purpose of the Study:

  • To provide an overview of bioavailability and bioequivalence definitions.
  • To outline the U.S. FDA's regulatory requirements and assessment processes for generic drugs.
  • To discuss fundamental assumptions, study designs, and practical considerations in bioequivalence assessment.

Main Methods:

  • Review of U.S. FDA regulations and guidelines.
  • Explanation of bioequivalence study design and statistical analysis.
  • Discussion of practical issues like highly variable drugs and interchangeability.

Main Results:

  • The article defines key terms and outlines the regulatory framework.
  • It details the process for assessing bioequivalence of generic drug products.
  • Practical considerations and criteria for various drug types are discussed.

Conclusions:

  • Bioavailability and bioequivalence studies are essential for generic drug approval.
  • The U.S. FDA employs specific criteria and methods for bioequivalence assessment.
  • Ensuring bioequivalence supports drug interchangeability and patient safety.