Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
This focused clinical trials reference brings together study design, endpoints, biomarkers, drug safety, and FDA and ICH guidelines. It offers readers an organized overview of major concepts involved in planning, evaluating, and regulating clinical research, making it a useful resource for study and professional reference.
About This Book
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines presents a focused overview of key areas in clinical trial practice.
The book addresses study design, endpoints, and biomarkers, highlighting core concepts used to structure and evaluate clinical research.
It also covers drug safety, an essential consideration in the development and assessment of medical products.
Regulatory guidance from the FDA and ICH is included, making the subject relevant to readers seeking an organized introduction to clinical trial methodology and oversight.
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