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Clinical Trial Design Essentials by Samip Thapaliya is a document available to read on EtoBox.
What is Clinical Trial Design Essentials about?
The document outlines the requirements and principles of designing clinical trials, particularly emphasizing the need for adequate and well-controlled studies as mandated by the 1962 FD&C Act. It discusses the importance of demonstrating drug effectiveness through substantial evidence, which includes the necessity for multiple controlled trials and minimizing bias in study design. Additionally, it covers various types of control groups and study designs, including non-inferiority and equivalence trials, whi
- Author
- Samip Thapaliya
- Language
- EN