Related Experiment Video
Updated: Jun 17, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
Published on: June 17, 2015
An overview of developmental and reproductive toxicity risk assessment in China
Haixue Wang1, Qingli Wang, Mingyang Liao
1Center for Drug Evaluation, State Food and Drug Administration, Jia-1, Fuxing Road, Beijing 100038, China. haixue_wang@yahoo.com
Abstract:
Development and reproductive toxicology (DART) studies in animals are integral parts of nonclinical safety evaluation of drugs. The State Food and Drug Administration (SFDA) of the People's Republic of China developed a new guideline on DART studies in 2006. This guideline is in broad agreement with ICH guideline S5A (1994), "Detection of Toxicity to Reproduction for Medical Products," and M3, "Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals." However, the new guideline on DART testing differs from ICH in some detailed requirements. This overview reviews some main specifications in China's guidelines on DART testing, and also briefly introduces the recommendations for conducting human clinical trials and marketing authorization in China.
Related Concept Videos
Toxicity Testing in Animals
Preclinical Development: Overview
Mutagenicity and Carcinogenicity
Teratogenicity
Toxicokinetics: Overview
Toxic Reactions: Overview
Toxicity falls into two primary categories: local and systemic.
Local toxicity appears at the exposure site, such as protein denaturation caused by caustic substances.
In contrast, systemic toxicity requires the toxic agent's absorption and distribution,...

