The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies
作者： Gerhard F. Weinbauer , Joerg Luft , Antje Fuchs
DOI: 10.1007/978-1-62703-131-8_15
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摘要: The enhanced pre- and postnatal (ePPND) study design has been developed in response to new scientific knowledge subsequent guideline changes [ICH M3(R2) ICH S6(R1)]. were basically driven by the experiences obtained during preclinical development of biopharmaceuticals. standard ePPND concept does not apply conventional small molecule pharmaceuticals. In essence, is a (PPND) which key elements an embryo-fetal are investigated newborns infants rather than fetus. cynomolgus monkey current relevant nonhuman primate model. S6(R1) reached step 5 June 2011 provides detailed recommendations on various parameters conduct study. This chapter working guidance for monitoring menstrual cycles generate pregnant animals, ultrasound pregnancy, morphometric measurements fetuses newborns, vivo skeletal examination, protocols evaluation (e.g., neurobehavioral assessment, learning memory test, grip strength, immune system evaluation) comprehensive list additional infant monkey.
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