ArticleCurrent research in toxicology2025
Strategy for reproductive and developmental toxicity (DART) studies for marketing applications in pharmaceutical development.
Article in Current research in toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Advancing Developmental and Reproductive Toxicity Research: Mechanistic Coverage, NAM Approaches, and Integrative Strategies.Current research in toxicology · 2026Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Studies on reproductive toxicity are conducted to assess the effects of chemicals and pharmaceuticals on the reproductive function and fetal development. However, depending on the indication or modality, Fertility and Early Embryonic Development (FEED), Embryo-Fetal Development (EFD), and Pre/Postnatal Development (PPND) studies which evaluate all reproductive stages or EFD studies in a second species may not be necessary. Therefore, based on the Common Technical Document (CTD), PMDA review reports, and other documents of drugs with new active ingredients approved in Japan, we aimed to investigate the implementation status of DART studies by classifying the studies into FEED, EFD, and PPND types, and summarizing the reasons for not conducting the studies. This survey was conducted by the Reproductive and Developmental Toxicity Team of the Japan Pharmaceutical Manufacturers Association (JPMA) to address issues related to DART studies conducted as non-clinical studies for drug development. Of the three DART studies, 35% of drugs received marketing application without conducting EFD studies in at least one species. Among the three study types, PPND studies were the second most frequently waivered, with 36% not conducted. FEED studies had the lowest implementation rate among the three types of studies, with 40% not conducted. The primary reason for waiving at least one study was compliance with ICH S5, S6, S9, and M3 guidelines. In conclusion, the necessity of DART studies varied depending on the applicable ICH guideline and the characteristics of the drug, including therapeutic indication, target, endogenous substances, low exposure, and ADA formation. This suggests that the need for DART studies may be waived because of various reasons, each of which should be justified based on scientific rationale and risk analysis.
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