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.
Reproductive Toxicology, 2015
Scialli AR, Bailey G, Beyer BK, Bøgh IB, Breslin WJ, Chen CL, ...
- HESI - Health and Environmental Sciences Institute
Small molecule pharmaceutical products are assumed to reach concentrations in semen similar to those in blood plasma.
Reproductive Toxicology, 2015
Thompson KE, Newcomb DL, Moffat GJ, Zalikowski J, Chellman GJ, ...
- HESI - Health and Environmental Sciences Institute
Given concern about potential embryo-fetal harm following seminal exposure to drugs with teratogenic potential, pharmaceutical companies use theoretical calculations to estimate seminal concentrations, maternal exposure, and distribution across the placenta to the embryo-fetal compartment for risk ...
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2014
Daston GP, Beyer BK, Carney EW, Chapin RE, Friedman JM, ...
- HESI - Health and Environmental Sciences Institute
Validation of alternative assays requires comparison of the responses to toxicants in the alternative assay with in vivo responses.
Reproductive Toxicology, 2014
Breslin WJ, Hilbish KG, Page TJ, Coutant DE
- HESI - Health and Environmental Sciences Institute
Studies were conducted in New Zealand White rabbits to assess the seminal transfer, vaginal absorption, and placental transfer of a therapeutic monoclonal antibody (T-IgG4).
Reproductive Toxicology, 2014
Moffat GJ, Davies R, Kwon G, Retter MW, Chellman GJ, Kanapuram S, ...
- HESI - Health and Environmental Sciences Institute
To assess the potential for male-mediated drug transfer to their female partner and/or developing conceptus, vaginal uptake of a monoclonal antibody(mAb) biotherapeutic was assessed in cynomolgus monkeys.
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