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Related Concept Videos

Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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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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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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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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Bioequivalence Data: Statistical Interpretation01:16

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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...
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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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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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On assessing bioequivalence and interchangeability between generics based on indirect comparisons.

Jiayin Zheng1,2, Shein-Chung Chow1,2, Mengdie Yuan3

  • 1National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

Statistics in Medicine
|May 13, 2017
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Summary
This summary is machine-generated.

Assessing bioequivalence and interchangeability between generic drugs is crucial due to safety concerns. This study proposes new methods using indirect comparisons for evaluating generic drug interchangeability, especially for malaria and HIV/AIDS medications.

Keywords:
average bioequivalencedrug interchangeabilitygenericsgeometric mean ratio (GMR)indirect comparison

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Area of Science:

  • Pharmacokinetics and Pharmaceutical Sciences
  • Drug Regulatory Affairs
  • Biostatistics

Background:

  • Generic drug approval does not currently require bioequivalence assessment for interchangeability.
  • Interchangeable use of generics raises safety and efficacy concerns without established monitoring.
  • Existing regulatory frameworks may not adequately address the complexities of generic drug comparisons.

Purpose of the Study:

  • To propose novel methods for assessing bioequivalence and interchangeability among generic drugs using indirect comparisons.
  • To discuss the applicability and assumptions of these methods in the context of generic drug evaluation.
  • To highlight the limitations of directly applying adjusted indirect comparisons to generic drug assessments.

Main Methods:

  • Development of statistical methods based on indirect comparisons for bioequivalence assessment.
  • Exploration of similarity assumptions and their impact on interchangeability evaluations.
  • Incorporation of clinical trial considerations such as multiple comparisons and simultaneous testing for multiple generics.
  • Extensive simulation studies to validate the performance of the proposed methods.

Main Results:

  • The proposed indirect comparison methods provide a framework for assessing bioequivalence and interchangeability.
  • Simulation studies demonstrated the effectiveness of the developed methods.
  • Real-world examples using WHO prequalified malaria and HIV/AIDS generics illustrated the practical application of the methods.

Conclusions:

  • The proposed methods offer a robust approach to evaluating the interchangeability of generic drugs.
  • These methods can enhance the safety and efficacy monitoring of generics in clinical practice.
  • Further research and regulatory consideration of these indirect comparison techniques are warranted for improved generic drug oversight.