Clinical trial design for immunomodulatory bololgics

Abstract

Keywords

clinical trial immunomodulatory biologics preclinical pharmacokinetics pharmacodynamics

References

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2 ICH Harmonized Tripartite Guideline (S6) . Preclinical safety evaluation of biotechnology-derived pharmaceuti-cals . Federal Register 1997; 62: 61515-61519 .

3 ICH Harmonized Tripartite Guideline (El) . The extent of population exposure to assess clinical safety . Federal Register 1995; 60: 11270-11270 .

4 ICH Harmonized Tripartite Guideline (E6) . Good clinical practice: Consolidated guidance . Federal Register 1997; 62: 25692-25709 .

5 ICH Harmonized Tripartite Guideline (E8) . Guidance on general considerations for clinical trials . Federal Register 1997; 62: 66113-66119 .