EFDT研究的6r。

IF 1.6 4区医学 Q4 DEVELOPMENTAL BIOLOGY Birth Defects Research Pub Date : 2025-01-01 DOI:10.1002/bdr2.2429

L David Wise

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引用次数: 0

摘要

鉴于对科学研究的可重复性、可复制性和可靠性的日益关注，胚胎-胎儿发育毒性（EFDT）研究从这一角度与经典的3r一起进行了检查。这些6r有助于外部有效性（即对人类安全的适用性）。物种差异和实验条件在不同程度上降低了所有临床前研究的有效性。明显缺乏/缺乏证明重复EFDT研究降低了信度和效度。我提出的建议旨在增加这些研究继续使用的可靠性，这些研究是评估人类怀孕期间安全性的基石。有经验的读者会认识到，这些建议也适用于其他指导方针规定的发育和生殖毒性以及毒性研究。

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The 6Rs of EFDT Studies.

Given the increased concerns over reproducibility, replicability, and reliability of scientific studies, the embryo-fetal developmental toxicity (EFDT) study was examined from this perspective together with the classic 3Rs. These 6Rs contribute to external validity (i.e., applicability to human safety). Species differences and experimental conditions lower the validity of all preclinical studies to variable extents. The apparent lack/paucity of demonstrated replicate EFDT studies lowers reliability and thus validity. I make suggestions intended to add reliability for the continued use of these studies, which are a cornerstone for assessing safety during human pregnancies. Experienced readers will recognize that the suggestions would also apply to other guideline-mandated developmental and reproductive toxicity and toxicity studies.

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来源期刊

Birth Defects Research Medicine-Embryology

CiteScore

3.60

自引率

9.50%

发文量

153

期刊介绍： The journal Birth Defects Research publishes original research and reviews in areas related to the etiology of adverse developmental and reproductive outcome. In particular the journal is devoted to the publication of original scientific research that contributes to the understanding of the biology of embryonic development and the prenatal causative factors and mechanisms leading to adverse pregnancy outcomes, namely structural and functional birth defects, pregnancy loss, postnatal functional defects in the human population, and to the identification of prenatal factors and biological mechanisms that reduce these risks. Adverse reproductive and developmental outcomes may have genetic, environmental, nutritional or epigenetic causes. Accordingly, the journal Birth Defects Research takes an integrated, multidisciplinary approach in its organization and publication strategy. The journal Birth Defects Research contains separate sections for clinical and molecular teratology, developmental and reproductive toxicology, and reviews in developmental biology to acknowledge and accommodate the integrative nature of research in this field. Each section has a dedicated editor who is a leader in his/her field and who has full editorial authority in his/her area.