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Re: crablover post# 144753

Friday, 07/20/2018 1:38:25 PM

Friday, July 20, 2018 1:38:25 PM

Post# of 203908
"...the only thing proven, is that the so called cream works on healthy patients.

Good job so far! Now, that is part I of the two parts of Phase I in a FDA study.

Here is more information to help understand the whole phase I process better.

FYI- $OWCP is already finishing part II of phase I. smile

"Phase I

Phase I trials were formerly referred to as “first-in-man studies” but the field generally moved to the gender-neutral language phrase "first-in-humans" in the 1990s;these trials are the first stage of testing in human subjects.They are designed to test the safety, side effects, best dose, and formulation method for the drug.
Normally, a small group of 2–100 healthy volunteers will be recruited.These trials are often conducted in a clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organization (CROs) who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. This phase is designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase I trials normally include dose-ranging, also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer."

https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_I