How to design and write a clinical research protocol in Cosmetic Dermatology

Ediléia Bagatin1, Helio A Miot

  • 1Federal University of Sao Paulo (Universidade Federal de Sao Paulo - UNIFESP), Sao Paulo, SP, Brazil. edileia_bagatin@yahoo.com.br

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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