Published 2021
Table of Contents:
“…3.4 SYSTEMS TOXICOLOGY-BASED ASSESSMENT OF ENDPS -- 3.4.1 Predictive Power of Systems Toxicology -- 3.5 A COMPREHENSIVE ASSESSMENT PROGRAM FOR ENDPS -- 3.5.1 Toxicological Assessment Steps -- 3.5.1.1 Step I -- 3.5.
1.2 Step II -- 3.5.1.3 Step III -- 3.5.1.4 Step IV -- 3.6 QUALITY CONSIDERATIONS -- 3.6.1 Comparative Studies -- 3.6.2 Exposure and its Verification -- 3.6.2.1 Adequate exposure -- 3.6.2.2 Exposure verification in nonclinical studies -- 3.6.2.3 Exposure verification in clinical studies -- 3.6.3 Independent Peer Review -- 3.7 TRANSPARENT SHARING OF SCIENTIFIC DATA ON ENDP ASSESSMENT…”
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