1 ICH Harmonized Tripartite Guideline (M3) . Timing of non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals . Federal Register1997; 62: 62922-62925 .
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2 ICH Harmonized Tripartite Guideline (S6) . Preclinical safety evaluation of biotechnology-derived pharmaceuti-cals . Federal Register1997; 62: 61515-61519 .
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3 ICH Harmonized Tripartite Guideline (El) . The extent of population exposure to assess clinical safety . Federal Register1995; 60: 11270-11270 .
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4 ICH Harmonized Tripartite Guideline (E6) . Good clinical practice: Consolidated guidance . Federal Register1997; 62: 25692-25709 .
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5 ICH Harmonized Tripartite Guideline (E8) . Guidance on general considerations for clinical trials . Federal Register1997; 62: 66113-66119 .
