Description

The aim of this book entitled "Ethical Guideline on Paediatric Drug Development; Regulatory Aspects" is to produce an informative and readable collection of 12 short chapters that providing almost all you wanted to know about Principles and Practice of Paediatric clinical trial. The Author hope the book would be a potential source of great pleasure to readers. Inside you'll find- Is Clinical Trial Right for A Child, Foundation of Paediatric Clinical Research, Ethical Conduct of Paediatric Clinical Studies, Principles and Practice of Paediatric clinical trial, Paediatric legislation and health authorities, Paediatric Drug Development, Ethical & Regulatory issues and challenges with Paediatric Subjects, Assent process and Parental permission of Paediatric subject, The Child As Vulnerable patient (Protection And Empowerment), PIP, Reviewing and Reporting Unanticipated Problems, involving Risk to Paediatric Subjects or Associated Adverse Events (ADRs/ AEs/ SAEs/ SUSAR), Post Marketing Surveillance studies (Phase 4) of medicines used by paediatric population -Dr. Mahendra Singh Ashawat Ph.D (M.Pharm), Nilima Kanwar Hada B.Pharm, PGDACR (Clinical Research)