Calculating l Safe Start t Doses from Toxicology Studies

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Food and Drug Administration July, 2005
CDER guidance on “start dose” ‣ Selection of maximum safe starting dose for first-in- human trial (cf. Guidance for Industry: Estimating i the <strong>Safe</strong> <strong>Start</strong>ing Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers July 2005) ‣ Relevant for small molecule or biologic therapeutics ‣ Not intended to address dose-escalation or maximum clinical doses, or dosing in patient populations. p ‣ Toxicity is to be avoided at the initial dose. ‣ Approaches other than that described may be used (e.g., PK/modeling); however, approach selected needs to be justified. Food and Drug Administration
Page 1: Calculating l Safe Start t Doses fr
Page 5 and 6: Safety Factor ‣ Application of sa
Page 7 and 8: Changes in start t dose ‣ It is a
Page 9 and 10: Food and Drug Administration
Page 11 and 12: Events in clinical trial ‣ TeGene
Page 13 and 14: CD28 Monoclonal Trial in UK ‣ No
Page 15 and 16: Could this toxicity have been predi
Page 17 and 18: Other clues ‣ OKT3, murine monocl
Page 19 and 20: Reaction to Tegenero Incident ‣ E
Page 21 and 22: MABEL Approach ‣ “Minimal Antic
Page 23 and 24: EMEA Guidance ‣ On its face, this

Calculating l Safe Start t Doses from Toxicology Studies

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