Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates

Weinbauer, Gerhard F.; Frings, Werner; Fuchs, Antje; Niehaus, Michael; Osterburg, Ingrid

doi:10.1002/9780470571224.pse177

Cited by 5 publications

(1 citation statement)

References 43 publications

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“…Determining the corresponding immunologic age of an NHP to that of a human can be difficult. Parameters that can be used include the relative ratios of CD4:CD8 cells (Hendrickx, Peterson, and Makori 2005;Weinbauer et al 2008) and also serum immunoglobulin levels (Buse 2005;Hendrickx, Peterson, and Makori 2005;Isaacs et al 1983) because both change after birth over time.…”

Section: Integrated Approaches To Developmental Immunotoxicology Assementioning

confidence: 99%

Toxicopathology of the Developing Immune System

et al. 2010

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Developmental immunotoxicity (DIT) has gained attention with the recognition that environmental chemicals can potentially affect the developing immune system and the incidence of childhood allergic diseases. Preclinical safety assessment of pharmaceuticals for men and women of childbearing potential as well as for pediatric and juvenile indications may require DIT assessments. Draft documents from environmental and chemical regulatory agencies propose strategies that use the rat as a test species and incorporate histopathology and functional testing as endpoints. While there are no guidelines for DIT assessment of pharmaceuticals, current discussions suggest that combining immunotoxicity and developmental and reproductive toxicology studies may serve this purpose. Knowledge of the principles and applications of DIT will facilitate participation in strategy development and effective conduct of relevant studies.

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