What are some of the key nonclinical pharmacology findings

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Reference no: EM133370483

Topic: Analysis of the ITCA-650 IB

Nonclinical safety:

What are some of the key nonclinical pharmacology findings of nonclinical studies of ITCA-650? (Example: Effects of body weight? Fat mass? Cardiovascular safety?)
How many toxicity studies were conducted and in what species?
Clinical Safety (Effects in Humans)
What is the intended indication of ITCA-650?
Summarize the Absorption, Distribution, Metabolism, and Elimination of ITCA-650
How many Phase 1, 2, and 3 studies of ITCA-650 have been run so far?
What kinds of drug-drug interactions have been observed with ITCA-650?
What is the overall benefit-risk profile of ITCA-650 at this stage of development?
Summarize 1 or 2 expected AEs and describe why these AEs are considered expected for ITCA-650

Reference no: EM133370483

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