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International Conference preclinical safety testing

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 safety testing is mentioned: [Pg.305] [Pg.129] [Pg.9] [Pg.126] [Pg.208] [Pg.529] [Pg.734] [Pg.838] [Pg.45] [Pg.397] [Pg.8] [Pg.193] [Pg.301] [Pg.212]

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Conference testing

International Conference

International Conference Conferences

International Conference preclinical tests

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Preclinical testing

Safety conference

Safety testing

Safety testing preclinical

Safety tests