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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better u

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Care Quality --- Health Care Quality --- Healthcare Quality --- Pharmacy Audits --- Healthcare Quality, Access, and Evaluation --- legislation & jurisprudence --- methods --- Drugs --- Testing. --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Drug development --- Effectiveness --- Testing --- Evaluation