SIB Testing for Carcinogenicity of Pharmaceuticals

ICH SIB, Testing for Carcinogenicity of Pharmaceuticals, Issued February 1998, Available at http / / www.fda.gov / cder / guidance. [Pg.304]

Safety ICH SIA Guideline on the need for carcinogenicity studies of pharmaceuticals ICH SIB Testing for carcinogenicity of pharmaceuticals ICH SIC Dose selection for carcinogenicity studies of pharmaceuticals ICH SIC(R) Addendum to SIC addition of a Umit dose and related notes Step 5 (1995) Step 5 (1997) Step 5 (1994) Step 5 (1997)... [Pg.554]

International Conference on Harmonisation (July 1997). SIB Testing for Carcinogenicity of Pharmaceuticals, http //www.ich.org/cache/compo/276-254-l.htm... [Pg.746]

S1A need for long-term rodent carcinogenicity studies of pharmaceuticals and SIB testing for carcinogenicity of pharmaceuticals and FDA GLP 480 mice... [Pg.870]

Carcinogenicity Study in Sprague-Dawley Rats ICH S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals and ICH SIB Testing for Carcinogenicity of Pharmaceuticals (2yr) 8-10 26-30 1-1.5 M... [Pg.909]

ICH Harmonised Tripartite Guideline (SIB). Testing for carcinogenicity of pharmaceuticals. July 16, 1997. [Pg.54]

Food and Drug Administration. Guidance for Industry SIB Testing for carcinogenicity of pharmaceuticals 1997 1-10. [Pg.282]

SIB Draft Guideline on Testing for Carcinogenicity of Pharmaceuticals Notice Nov 98... [Pg.77]

SIB Carcinogenicity Testing for Carcinogenicity of Pharmaceuticals CPMP/ICH/299/95 Step 5... [Pg.762]

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