Non-clinical safety study for the conduct

Timing of Non-Clinical Safety Studies for the Conduct of Human Clinical trials for Pharmaceuticals. Fourth International Conference on Harmonization. International Conference on Harmonization, Brussels, 1997. [Pg.476]

Anon., ICH M3 Timing of non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, CPMP/ICH/286/95,1997, Modified version released November 2000. [Pg.279]

ICH, Topic M3 (Rl). Note for Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 2000 (CPMP/ICH/286/95). [Pg.983]

Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals... [Pg.641]

In Europe, the European Commission (EC), through its Directorate General, DG III, responsible for trade including pharmaceuticals, and the Committee for Proprietary Medicinal products (CPMP), issued, on November 20 1996, draft notes for guidance, with a 6 month consultation period, on (a) non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95) and (b) general considerations for clinical trials (CPMP/ICH/291/95). Further revisons are expected. A directive on good clinical practices (GCP) will follow. [Pg.456]

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