TESU has discovered a new fictitious compound called Edistatin, a Low-Chol, they believe has promising pharmacologic benefit
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TESU has discovered a new fictitious compound called Edistatin, a Low-Chol, they believe has promising pharmacologic benefit
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TESU has discovered a new fictitious compound called Edistatin, a Low-Chol, they believe has promising pharmacologic benefit. A patent was granted for the compound, and all of the required animal testing was submitted to the FDA with the IND application. The FDA gave approval to proceed with human testing. Construct a one-page summary of what you think should be the required studies Phase I, II, and III to submit in the NDA. For each phase, include the objective of the study (studies), type of subjects selected, outcomes measures (i.e. cholesterol reduction and safety), and results. Be creative!! There are no right or wrong answers. We are interested in your approach based upon your readings.
Background: Assume that the effective dose is 10 and 20 mg. The safety profile is that of other statin products such as Lipitor, etc.
