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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
Developmental and reproductive toxicology studies in nonhuman primates
Gary J Chellman1, Jeanine L Bussiere, Norbert Makori
1Charles River Preclinical Services, Reno, Nevada 89511, USA. gary.chellman@crl.com
Summary
Nonhuman primates (NHPs) are crucial for biopharmaceutical drug development due to human-like responses. This study details NHP study designs for reproductive and developmental toxicology, optimizing testing efficiency.
Area of Science:
- Toxicology
- Pharmacology
- Primate Research
Background:
- Nonhuman primates (NHPs) are increasingly used in drug development, particularly for biopharmaceuticals, due to their similar pharmacological responses to humans.
- NHPs also aid in resolving reproductive toxicology issues observed in traditional species like rodents and rabbits.
- The unique physiological characteristics of NHPs make them essential models for specific toxicological assessments.
Purpose of the Study:
- To present adequate study designs for developmental and reproductive toxicology testing in nonhuman primates (NHPs).
- To discuss optional parameters and novel consolidated study designs to conserve NHP resources.
- To guide scientists in optimizing NHP study designs for pharmaceutical, regulatory, and contract research.
Main Methods:
- Detailed descriptions of NHP study designs for various toxicological endpoints.
- Inclusion of optional parameters and novel consolidated study designs.
- Consideration of case-by-case optimization for study designs.
Main Results:
- Adequate designs are presented for embryo-fetal development, pre- and post-natal development, and juvenile toxicity studies in NHPs.
- Designs address both male and female reproductive toxicity assessments.
- New designs consolidate multiple reproductive assessment aspects, conserving limited NHP resources.
Conclusions:
- NHP models are vital for comprehensive developmental and reproductive toxicology testing of pharmaceuticals.
- Optimized study designs, including consolidated approaches, are essential for efficient and ethical NHP use.
- This work provides a framework for scientists to design and conduct robust NHP toxicology studies.
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