Calculating l Safe Start t Doses from Toxicology Studies

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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 and 20: Reaction to Tegenero Incident ‣ E
Page 21: MABEL Approach ‣ “Minimal Antic

Calculating l Safe Start t Doses from Toxicology Studies

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