| FIRST
IN HUMAN STUDIES
The staff and investigator
at Clinical Pharmacology of Miami have extensive experience with
designing and implementing “First in Man” studies. This
is one of the most critical steps in the entire drug development
process. Competence at this point is important so that a potential
blockbuster drug that can save lives and prevent suffering will
not be erroneously discarded and that a potentially unsafe drug
is not continued in the research pipeline needlessly costing millions
of dollars and exposing countless research subjects to unnecessary
risk. Clinical Pharmacology of Miami can help you avoid these pitfalls
by helping design and implement your study according to sound scientific
principles.
Guidance for Industry:
Estimating the Maximum Safe Starting Doses in Initial Clinical
Trials for Therapeutics in Adult Healthy Volunteers
2005 US Food and Drug Administration
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