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Good Laboratory Practices clinical trial guidelines

In addition, all nonclinical toxicology studies that are intended to support clinical trials or marketing applications must be conducted in compliance with Good Laboratory Practices guidelines... [Pg.63]

The International Committee on Harmonization (ICH) Good Clinical Practice guidelines E6(R1), EDA Regulations relating to good clinical practice and clinical trials (CER 21), and EDA Good Laboratory Practice guidelines may be helpful references. New projects that use an established biorepository are submitted for determination of review status (e.g., exempt, expedited, full board review). [Pg.203]

See other pages where Good Laboratory Practices clinical trial guidelines is mentioned: [Pg.137]    [Pg.108]    [Pg.108]    [Pg.495]    [Pg.17]    [Pg.829]    [Pg.108]    [Pg.459]    [Pg.371]    [Pg.26]    [Pg.27]    [Pg.165]    [Pg.295]    [Pg.226]    [Pg.180]    [Pg.346]    [Pg.361]    [Pg.8]    [Pg.197]   
See also in sourсe #XX -- [ Pg.186 , Pg.189 ]



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