کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8962467 1646579 2018 23 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Review of embryo-fetal developmental toxicity studies performed for pharmaceuticals approved by FDA in 2016 and 2017
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
Review of embryo-fetal developmental toxicity studies performed for pharmaceuticals approved by FDA in 2016 and 2017
چکیده انگلیسی
Details of embryo-fetal development (EFD) studies were compiled for all FDA drug approvals in 2016-17. Rats and rabbits were used for 63% of small molecule (SM) drugs. The cynomolgus monkey was used for 47% of biopharmaceuticals. Rodent studies using the clinical mAb or animal homologue replaced monkey studies under some circumstances. EFD studies were not required for anti-cancer drugs when the mode of action was associated with known developmental risk. One quarter of SM non-oncology drugs and all tested SM anti-cancer drugs were teratogenic in at least one species. The rat and rabbit were essentially equally sensitive to developmental toxicity. Eighty-nine percent of SM non-cancer drugs induced maternal or fetal toxicity in at least one species at below 25-times human exposure (proposed maximum exposure in the draft revised ICH S5(R3) guideline). The pregnancy and lactation labeling rule (PLLR) has brought consistency to the presentation of EFD data in drug labels.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Reproductive Toxicology - Volume 80, September 2018, Pages 117-125
نویسندگان
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