Drug Discovery and Clinical Research

by SK Gupta

Pharmaceutical industry is growing day continuously and there is a need for innovation and new drug design. The main purpose of the book is to provide succinctly and detailed drug development aspects and its updates. The book provides comprehensive details on process of drug development, history behind it, ethics involved, advances, and regulations and application process for marketing new drug various countries. Initially the book discusses drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. Clinical approaches phase 0 trials in cancer drug development, and bioethics in clinical research. Second part of the book mainly focuses on the medical devices used, vaccines development, and clinical development of anticancer molecules. Pharmacovigilance is very important aspect during development of new drug. Role of pharmacovigilance in clinical research and data management in pharmacovigilance is to be taken into account during development of new drug. Finally, the book focuses on the safety and medical monitoring in clinical trials, clinical trials in different regions, patient recruitment principle, importance of medical writing, pharmacovigilance of herbal drugs and outsourcing.

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