Reproductive Toxicology, 2015
Thompson KE, Rayhon SL, Bailey G, Delille P, McNerney ME
- HESI - Health and Environmental Sciences Institute
Risk assessment for indirect exposure to small molecule pharmaceuticals in semen to the conceptus has traditionally been handled by calculations based on assumptions that any embryo-fetal exposure would be secondary to maternal absorption and redistribution.
Regulatory Toxicology and Pharmacology, 2016
Solomon HM, Makris SL, Alsaid H, Bermudez O, Beyer BK, Chen A, ...
- HESI - Health and Environmental Sciences Institute
During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies.
Therapeutic Innovation & Regulatory Science, 2016
Stewart J, Breslin WJ, Beyer BK, Chadwick K, De Schaepdrijver L, ...
- HESI - Health and Environmental Sciences Institute
The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials.
Critical Reviews in Toxicology , 2016
Theunissen PT, Beken S, Beyer B, Breslin WJ, Cappon GD, Chen CL, ...
A database of embryo-fetal developmental toxicity (EFDT) studies of 379 pharmaceutical compounds in rat and rabbit was analyzed for species differences based on toxicokinetic parameters of area under the curve (AUC) and maximum concentration (Cmax) at the developmental lowest adverse effect level (dLOAEL). For the vast ...
Critical Reviews in Toxicology , 2016
Peter T. Theunissen, Sonja Beken, Bruce K. Beyer, ...
- HESI - Health and Environmental Sciences Institute
Regulatory non-clinical safety testing of human pharmaceuticals typically requires embryo–fetal developmental toxicity (EFDT) testing in two species (one rodent and one non-rodent). The question has been raised whether under some conditions EFDT testing could be limited to one species, or whether the testing in a second ...
Birth Defects Research, 2018
Scialli AR, Daston G, Chen C, Coder PS, Euling SY, Foreman J, ...
Summary from the HESI workshop on embryo‐fetal development testing, considers how we might design developmental toxicity testing if we started over with 21st century knowledge and techniques. The paper considers what might make current protocols more predictive for human risk.
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