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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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 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...
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...
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 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...

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Related Experiment Video

Updated: May 19, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

Statistical methods for assessing interchangeability of biosimilars.

Shein-Chung Chow1, Lan-Yan Yang, Aijing Starr

  • 1Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, U.S.A.

Statistics in Medicine
|August 18, 2012
PubMed
Summary
This summary is machine-generated.

Developing biosimilar biologics presents challenges due to manufacturing variability and immunogenicity. This study introduces a novel biosimilarity index using reproducibility probability for quantitative evaluation of biosimilarity and interchangeability.

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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

Related Experiment Videos

Last Updated: May 19, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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

Published on: May 4, 2017

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
08:31

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

Area of Science:

  • Biopharmaceutical Science
  • Regulatory Science
  • Analytical Chemistry

Background:

  • Biologic drug development differs significantly from small molecule drugs, facing variability in manufacturing and environmental factors.
  • The complexity, heterogeneity, and immunogenicity of biologics pose challenges for quantitative biosimilarity and interchangeability evaluations.
  • Current methods struggle to provide robust quantitative assessments for follow-on biologic products.

Purpose of the Study:

  • To propose a general, robust approach for the quantitative evaluation of biosimilarity and interchangeability.
  • To develop a novel biosimilarity index based on the concept of reproducibility probability.
  • To address the challenges in evaluating follow-on biologic products.

Main Methods:

  • Development of a general approach for biosimilarity assessment.
  • Utilizing the concept of reproducibility probability for quantitative evaluation.
  • Designing a biosimilarity index applicable across different criteria and study designs.

Main Results:

  • A novel biosimilarity index has been proposed.
  • The method is based on the principle of reproducibility probability.
  • The approach is designed to be robust and adaptable.

Conclusions:

  • The proposed biosimilarity index offers a generalizable quantitative method for evaluating biosimilarity and interchangeability.
  • This approach provides a robust framework for assessing follow-on biologics.
  • The method is independent of specific biosimilarity criteria or study designs, enhancing its applicability.