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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...

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Related Experiment Video

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Screening for Endocrine Activity in Water Using Commercially-available In Vitro Transactivation Bioassays

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Utility of In Vitro Bioactivity as a Lower Bound Estimate of In Vivo Adverse Effect Levels and in Risk-Based

Katie Paul Friedman¹, Matthew Gagne², Lit-Hsin Loo³

¹National Center for Computational Toxicology, Office of Research and Development, US Environmental Protection Agency, Research Triangle Park, NC, 27711.

Toxicological Sciences : an Official Journal of the Society of Toxicology

|September 19, 2019

Summary

High-throughput in vitro bioactivity data can speed up chemical safety evaluations. This study found that new approach methodologies (NAMs) provide protective estimates for points-of-departure (PODs) compared to traditional methods.

Keywords:

high-throughput screening high-throughput toxicokinetics new approach methodologies point-of-departure (POD)threshold of toxicological concern (TTC)

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Last Updated: Jan 19, 2026

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Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms

Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms

Published on: December 9, 2015

Area of Science:

Toxicology
Computational Chemistry
Risk Assessment

Background:

Traditional hazard assessments rely on extensive in vivo studies.
High-throughput in vitro bioactivity data offers a potential alternative for faster screening.
Establishing a protective point-of-departure (POD) is crucial for human health safety evaluations.

Purpose of the Study:

To compare PODs derived from new approach methodologies (NAMs) with traditional PODs for 448 chemicals.
To evaluate the utility of in vitro bioactivity and exposure predictions in screening-level assessments.
To assess the feasibility of using NAMs for accelerating chemical safety evaluations.

Main Methods:

Utilized high-throughput in vitro bioactivity and exposure prediction data.
Calculated PODs using 50th (PODNAM, 50) and 95th (PODNAM, 95) percentile credible intervals from in vitro to in vivo extrapolation.
Compared NAM-derived PODs against traditional PODs (PODtraditional) for 448 chemicals.

Main Results:

89% of chemicals had a PODNAM, 95 lower than PODtraditional, indicating NAMs provide a more conservative estimate.
For substances where PODtraditional < PODNAM, 95, values were typically within a factor of 10, with enrichment of organophosphate and carbamate insecticide features.
Bioactivity:exposure ratios identified 11 substances where high-throughput exposure predictions exceeded PODNAM, 95.
PODNAM, 95 exceeded the threshold of toxicological concern (TTC) for 90% of chemicals.

Conclusions:

In vitro bioactivity data from NAMs can serve as a protective estimate for PODs in screening-level assessments.
NAMs demonstrate feasibility in accelerating human health safety evaluations, though challenges remain.
The study highlights the potential of NAMs to inform early-stage chemical risk assessment and prioritization.