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Study conduct, good laboratory practice standards regulations

This study was exploratory and was not conducted in compliance with all Good Laboratory Practices (GLP) regulations however, GLP regulations were closely followed to the extent possible. Relevant Standard Operating Procedures (SOPs) were followed. [Pg.52]

Good Laboratory Practice 58.105(a) requires that all test articles be appropriately characterized. Compliance requires documentation that characterization has been done. The tests conducted to provide this documentation, however, are not GLP-regulated, although such tests wiU in many instances be subject to CGMP standards (e.g., when the test article will also be used in human clinical studies). [Pg.42]

See other pages where Study conduct, good laboratory practice standards regulations is mentioned: [Pg.127]    [Pg.832]    [Pg.12]    [Pg.574]    [Pg.43]    [Pg.301]    [Pg.36]    [Pg.83]    [Pg.68]    [Pg.386]    [Pg.35]    [Pg.27]    [Pg.1271]    [Pg.26]    [Pg.535]    [Pg.536]    [Pg.147]    [Pg.554]    [Pg.87]    [Pg.643]   
See also in sourсe #XX -- [ Pg.531 ]



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