Clinical Trials Scientific Aspects AND Legal & Procedural Aspects . M K Unnikrishnan [Aug 2006]. Scientific Aspects of Clinical Trial. Phases of Clinical Trial Phase I: First in man safety Phase II: First in patient d ose, dosage form Phase III: Efficacy, ADRs
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Clinical TrialsScientific AspectsANDLegal & Procedural Aspects
M K Unnikrishnan [Aug 2006]
Phases of Clinical Trial
* A wash out period of a week between two weeks of therapy
Elements of a Clinical Trial
2. 1-2 basic medical scientists.
3. 1-2 clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist / representative of NGO
6. One philosopher / ethicist / theologian
7. One lay person from the community
8. Member Secretary