Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
Moffit JS, Her LS, Mineo AM, Knight BL, Phillips JA, Thibodeau MS
- HESI - Health and Environmental Sciences Institute
Although histopathology is considered the gold standard for assessing testicular toxicity in the nonclinical setting, identification of noninvasive biomarkers for testicular injury are desirable to improve safety monitoring capabilities for clinical trials.
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, 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.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2007
Cline JM
- HESI - Health and Environmental Sciences Institute
This review provides a summary of the normal biology, development, and morphology of the breast in nonhuman primates (macaques), and of the major published work addressing hormonally-induced changes in the breast of these animals.
Pharmaceutics, 2020
Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, ...
- HESI - Health and Environmental Sciences Institute
Drug dosing in neonates should be based on integrated knowledge concerning the disease to be treated, the physiological characteristics of the neonate, and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug. It is critically important that all sources of information be leveraged to optimize dose selection for ...
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
Coulson M, Bickerton S, Betts CJ, Jacobsen M, Stewart J, ...
- HESI - Health and Environmental Sciences Institute
A cross-laboratory analytic evaluation of a commercially available human inhibin B ELISA for measuring inhibin B in rat serum and plasma has been undertaken.
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