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Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

Body: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...

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Body: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...

Clinically Relevant Drug Product Specifications: Methods of Establishment

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

Bioequivalence: Overview

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 Indications

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...

Pharmaceutical Equivalents

Pharmaceutical Equivalents

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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Related Experiment Video

Updated: Dec 9, 2025

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

Potency assignment of biotherapeutic reference standards.

Paul Faya¹, Matthew W Borer², Kristi L Griffiths¹

¹Statistics - Discovery / Development, Eli Lilly and Company, Indianapolis, IN, USA.

Journal of Pharmaceutical and Biomedical Analysis

|September 5, 2020

Summary

This summary is machine-generated.

Assigning potency to biotherapeutic reference standards is crucial for drug quality. This study proposes a roadmap using statistical methods to ensure accurate potency assignment, addressing challenges in bioassay variability and bias.

Keywords:

Bioassay Biotherapeutic Monoclonal antibody Potency Reference standard

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Last Updated: Dec 9, 2025

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

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

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

Published on: May 4, 2017

Area of Science:

Biopharmaceutical development
Drug quality control
Protein therapeutics

Background:

Biotherapeutic proteins are vital for treating cancers, infectious diseases, and autoimmune disorders.
Potency, reflecting biological activity and efficacy, cannot be determined by physical properties alone.
Cell-based bioassays against reference standards are used, but face challenges in variability and bias.

Purpose of the Study:

To propose a comprehensive roadmap for assigning potency to biotherapeutic reference standards.
To ensure compliance with the recommended two-tier system of standards.
To address challenges in potency assignment during pharmaceutical development and manufacturing.

Main Methods:

Development of a roadmap for potency assignment compliant with regulatory guidance.
Integration of statistical approaches for risk-based, phase-appropriate study design and acceptance criteria.
Inclusion of mitigation strategies for potential assay bias.

Main Results:

A structured approach for potency assignment to biotherapeutic reference standards is presented.
The roadmap incorporates statistical methodologies for robust study design and acceptance criteria.
Methods for mitigating assay bias are provided to enhance reliability.

Conclusions:

Accurate potency assignment to reference standards is vital for patient safety and drug quality.
The proposed roadmap offers a systematic, statistically sound approach to potency determination.
This framework supports reliable biotherapeutic manufacturing and quality assurance.