Concepts & Approaches For Clinical Trial Management

ISBN-13: 9783659126550 / Angielski / Miękka / 2012 / 456 str.

Harikesh Maurya; N. V. Satheesh Madhav; Lakshmayya Sanjay Gandhi

Opis

New drug discovery and development is a complex, flexible and cost-effective but systematic process that follows a sequence of clinical steps, rules and regulations governed by the experienced regulatory authorities in each country. The rules laid down by the experienced authorities consistently have need of the code of ethics by which every individual involved in clinical research has to stand. Besides these ethical principles, a clinical trial involves multidisciplinary functions which require concepts and approaches, using modern research tools and techniques. In this book, the authors discuss some of key functions in clinical trial management as drug development process, clinical trials design, good clinical practices, roles and responsibilities of clinical trial personnel, regulatory processes/issues and the processes involved in performing excellent monitoring functions for the successful clinical study. This book also facilitates the understanding of the importance of ethics in clinical studies and the evolution of various guidelines, rules and regulations for the management of a clinical trials.

O autorze

Mr. Harikesh maurya has obtained his M.Pharm (Pharmacology) in 2007. Since, then he has well experienced & key skills for handling Clinical Trials and worked as a Sr. CRA in Macleods Pharmaceutical ltd. R & D Centre, Mumbai (India) for 3 Years. Currently he is working as Assistant Professor in SIP Dehradun, Uttarakhand, INDIA.