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Related Concept Videos

Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

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...
Bioequivalence: Overview01:16

Bioequivalence: Overview

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

Bioequivalence of Drugs: Drugs with Multiple Indications

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 indication due to...
Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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...
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...

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Updated: May 26, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Viewpoint: observations on scaled average bioequivalence.

Scott D Patterson1, Byron Jones

  • 1Pfizer Vaccine Clinical Research, Collegeville, PA, USA. scott.patterson@pfizer.com

Pharmaceutical Statistics
|December 14, 2011
PubMed
Summary
This summary is machine-generated.

Scaled average bioequivalence (SABE) may allow greater exposure changes for highly variable drugs compared to the standard two one-sided test (TOST) procedure. Simulations reveal potential bias in SABE methods, impacting bioequivalence testing for generic drugs.

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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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Last Updated: May 26, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
08:59

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

Published on: December 3, 2020

Area of Science:

  • Pharmacokinetics and Biopharmaceutics
  • Statistical Methods in Drug Development
  • Regulatory Science

Background:

  • The two one-sided test (TOST) procedure is the standard for average bioequivalence testing of new drug formulations.
  • TOST requires large sample sizes for highly variable drugs (CV > 30%).
  • Scaled average bioequivalence (SABE) is a proposed alternative for regulatory review.

Purpose of the Study:

  • To evaluate the statistical implications of SABE procedures.
  • To assess the potential market impact of SABE implementation.
  • To compare SABE with TOST for bioequivalence testing.

Main Methods:

  • Analysis of existing data using SABE methods.
  • Simulation studies to evaluate SABE decision rules.
  • Assessment of bias and impact of missing data in SABE.

Main Results:

  • A constraint within SABE is identified as biased.
  • Missing data can introduce bias into SABE analyses.
  • SABE permits larger exposure variations during generic-to-generic switching.

Conclusions:

  • SABE implementation may lead to greater variability in drug exposure compared to TOST.
  • Potential biases in SABE require careful consideration during regulatory review.
  • Further research is needed to fully understand the implications of SABE for public health and drug markets.