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Generic GLP

GARNER BARGE Proposed FIFRA Generic GLP Standards... [Pg.141]

Pharmaceutical, medical, and biotech industries are regulated worldwide to be in compliance with cGMP and GLP principles. Each company is required to create validation SOPs to qualify its equipment, utilities, buildings, and personnel. The template validation SOPs available enable end users to understand principles and elements of GMP and provide documentation language ranging from generic to specihc, depending on the detail level of the requirements. [Pg.1141]

Figure 9-6 A generic strategy integrating the three facets of developmental toxicity risk assessment namely (a) the risk of pharmacologic modulation of the therapeutic target during gestation, (b) in silico, SAR and (c) in vitro screening. Abbreviations The chick embryo neural retina (CENR) embryonic stem cell test (EST), whole embryo culture (WEC), Good Laboratory Practice (GLP), Embryo/Fetal Developmental Toxicity (EFD) study. "Front-loading" is the conduct of the EFD study prior to Phase lib. Figure 9-6 A generic strategy integrating the three facets of developmental toxicity risk assessment namely (a) the risk of pharmacologic modulation of the therapeutic target during gestation, (b) in silico, SAR and (c) in vitro screening. Abbreviations The chick embryo neural retina (CENR) embryonic stem cell test (EST), whole embryo culture (WEC), Good Laboratory Practice (GLP), Embryo/Fetal Developmental Toxicity (EFD) study. "Front-loading" is the conduct of the EFD study prior to Phase lib.
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See also in sourсe #XX -- [ Pg.47 ]



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