Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Toxicity Testing in Animals

Toxicity Testing in Animals

Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...

Teratogenicity

Teratogenicity

The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...

Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Replicability in EFDT Studies: Implications of Context Dependence for Virtual Control Groups (VCGs).

Birth defects research·2026

Same author

Pharmacokinetics of cannabidiol and its metabolites in rhesus monkeys and New Zealand White rabbits.

Toxicological sciences : an official journal of the Society of Toxicology·2025

Same author

A Comparison of Spontaneous Tumor Incidence in Charles River Sprague Dawley Rats and Wistar Hannover Rats.

International journal of toxicology·2025

Same author

Perspectives on Implementing Virtual Control Groups in Developmental and Reproductive Toxicity Studies.

Birth defects research·2025

Same author

Subdivided Historical Data to Assess Replicability of the Rat Embryo-Fetal Developmental Toxicity Study.

Birth defects research·2025

Same author

The 6Rs of EFDT Studies.

Birth defects research·2024

Search research articles

Related Experiment Video

Updated: Jun 17, 2026

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

Embryo-fetal developmental toxicity study design for pharmaceuticals.

L David Wise¹, Jochen Buschmann, Maureen H Feuston

¹Merck Research Laboratories, West Point, Pennsylvania 19486, USA. ld_wise@merck.com

Birth Defects Research. Part B, Developmental and Reproductive Toxicology

|December 22, 2009

Summary

This guide details best practices for reproductive and developmental toxicity studies in pharmaceuticals, ensuring robust safety assessments for women of childbearing potential.

More Related Videos

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

Small Molecule Screening and Toxicity Testing in Early-stage Zebrafish Larvae

Small Molecule Screening and Toxicity Testing in Early-stage Zebrafish Larvae

Published on: March 7, 2025

Related Experiment Videos

Last Updated: Jun 17, 2026

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

Small Molecule Screening and Toxicity Testing in Early-stage Zebrafish Larvae

Small Molecule Screening and Toxicity Testing in Early-stage Zebrafish Larvae

Published on: March 7, 2025

Area of Science:

Pharmacology and Toxicology
Drug Development
Regulatory Science

Background:

Current pharmaceutical development relies on International Conference on Harmonization (ICH) S5(R2) guidelines for toxicity assessment.
Standard toxicity studies utilize rodent and rabbit models to evaluate developmental hazards.

Purpose of the Study:

To provide detailed guidance on designing and conducting reproductive and developmental toxicity studies for pharmaceuticals.
To align study timelines with clinical trials involving women of childbearing potential.
To explore optional study parameters and combined fertility/developmental toxicity designs.

Main Methods:

Detailed description of adequate study designs, including range-finding studies.
Guidance on data presentation for developmental toxicity assessments.
Recommendations for study initiation and duration relative to clinical phases.

Main Results:

The abstract does not contain specific results but outlines the comprehensive nature of the guidance provided.
The guidance covers standard and optional parameters for toxicity testing.
The document also introduces novel methods for enhancing or replacing current procedures.

Conclusions:

This comprehensive guide aims to standardize and improve the quality of reproductive and developmental toxicity studies.
It will assist laboratories, study planners, and regulatory agencies in conducting thorough pharmaceutical safety evaluations.
The outlined methods support the safe development of pharmaceuticals for women of childbearing potential.