Calculating l Safe Start t Doses from Toxicology Studies

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Mode of Action ‣ Nature and intensity (extent, amplification, duration, reversibility) of the effect of the drug on the target ‣ Shape of dose-response curve ‣ e.g. mechanism that bypasses physiological control mechanisms, CD3 or CD28 (supra-) agonists. Food and Drug Administration
MABEL Approach ‣ “Minimal Anticipated Biological Effect (MABEL). ‣ The anticipated dose level leading to a minimal biological effect in humans. Receptor binding and receptor occupancy studies in vitro in target cells <strong>from</strong> human and the relevant animal(s) species and in vivo in the relevant animal species. Concentration-response response curves in vitro in target cells <strong>from</strong> human and the relevant animal(s) species and dose response in vivo in the relevant animal species. Exposure at pharmacological doses in the relevant species. Food and Drug Administration
Page 1 and 2: Calculating l Safe Start t Doses fr
Page 3 and 4: CDER guidance on “start dose”
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: Reaction to Tegenero Incident ‣ E
Page 23 and 24: EMEA Guidance ‣ On its face, this

Calculating l Safe Start t Doses from Toxicology Studies

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