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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,...
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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

361
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...
361
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

302
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...
302
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

309
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...
309
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

239
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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Assessing bioequivalence and drug interchangeability.

Meng Chen1, Shein-Chung Chow1

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

Journal of Biopharmaceutical Statistics
|December 10, 2016
PubMed
Summary

This study evaluates criteria for drug interchangeability, determining if generic drugs are switchable from originator products. It compares methods to ensure generic drug quality and safety for patient confidence.

Keywords:
Drug interchangeabilityreplicated crossover designreversed average bioequivalencescaled criterion for drug interchangeability (SCDI)variability due to subject-by-drug interaction

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Regulatory Science
  • Biostatistics

Background:

  • Generic drug substitution is approved by the FDA, but interchangeability between different generic versions of the same drug is not guaranteed.
  • The increasing number of generic drug products raises concerns about their consistent quality, safety, and efficacy.
  • Existing criteria for assessing drug interchangeability include individual bioequivalence, subject-by-drug interaction variability, and the scaled criterion for drug interchangeability (SCDI).

Purpose of the Study:

  • To investigate the interchangeability and switchability between generic (test) and originator (reference) drug products.
  • To evaluate the performance of existing and newly proposed criteria for drug interchangeability.
  • To assess drug interchangeability under various similarity scenarios using a replicated crossover design.

Main Methods:

  • Performance evaluation of drug interchangeability criteria, including the scaled criterion for drug interchangeability (SCDI) and a novel reversed average bioequivalence criterion.
  • Utilizing a 2x4 replicated crossover design to study drug switchability.
  • Analysis of passing percentages under best-case and worst-case similarity scenarios.

Main Results:

  • The study compares the effectiveness of different criteria in assessing drug interchangeability.
  • Performance metrics were analyzed under optimal and suboptimal conditions of drug similarity.
  • The research provides insights into the switchability of generic drugs based on established and novel bioequivalence criteria.

Conclusions:

  • The findings contribute to understanding the complex issue of drug interchangeability beyond basic bioequivalence.
  • The evaluation of different criteria offers guidance for regulatory bodies and pharmaceutical manufacturers.
  • This research supports the goal of ensuring patient safety and therapeutic equivalence when switching between generic and originator drugs.