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International Conference preclinical tests

The basic safety studies, including the International Conference on Harmonization (ICH) standard series of preclinical tests, receive close attention in the NDA review. Even if specific ICH studies were never discussed in the pre-IND meeting, the IND review, and the pre-NSDA meeting, they should be addressed in the NDA. [Pg.124]

See other pages where International Conference preclinical tests is mentioned: [Pg.9]    [Pg.773]    [Pg.305]    [Pg.8]    [Pg.126]    [Pg.208]    [Pg.529]    [Pg.734]    [Pg.831]    [Pg.838]    [Pg.97]    [Pg.7]    [Pg.45]    [Pg.78]    [Pg.8]    [Pg.193]    [Pg.301]    [Pg.129]    [Pg.212]    [Pg.397]   
See also in sourсe #XX -- [ Pg.124 ]



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