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Updated: Jun 17, 2026
06:38
Determination of Reproductive Competence by Confirming Pubertal Onset and Performing a Fertility Assay in Mice and Rats
Published on: October 13, 2018
The nonclinical fertility study design for pharmaceuticals
Steven A Lerman1, Kok Wah Hew, Jane Stewart
1GlaxoSmithKline R&D, King of Prussia, Pennsylvania 19406-0939, USA. steven.2.lerman@gsk.com
Summary
This review examines fertility study designs for pharmaceuticals, focusing on rat studies and harmonization efforts. It aims to standardize critical design features for regulatory submissions and enhance understanding among stakeholders.
Area of Science:
- Pharmacology
- Toxicology
- Reproductive Science
Background:
- Current pharmaceutical toxicity assessment relies on ICH S5(R2) guidelines.
- Fertility studies are crucial for evaluating drug safety in humans of reproductive potential.
- Rat models are predominantly used for assessing male fertility effects.
Purpose of the Study:
- To review the evolution and harmonization of fertility study designs.
- To detail acceptable design elements and data presentation recommendations.
- To clarify the timing of nonclinical fertility studies relative to clinical trials.
Main Methods:
- Review of historical development and harmonization of fertility study designs.
- Analysis of specific design components and data reporting standards.
- Examination of study timing in relation to clinical trial phases.
Main Results:
- Harmonization efforts have refined fertility study designs.
- Specific recommendations for study design and data presentation are provided.
- Strategies for integrating fertility assessments with other toxicity studies are discussed.
Conclusions:
- A common understanding of critical fertility study design features is essential.
- Standardized approaches improve the assessment of drug-induced reproductive toxicity.
- This review aids testing laboratories, sponsors, and regulatory agencies in evaluating pharmaceutical safety.
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