The staff and investigators 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