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Ethical Guideline on Paediatric Drug Development; Regulatory Aspects


Marketed By :  LAP LAMBERT Academic Publishing   Sold By :  Kamal Books International  
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  • Product 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)

Product Specifications
SKU :COC85236
AuthorMahendra Singh Ashawat and Nilima Kanwar Hada
Number of Pages252
Publishing Year2013-12-04T00:00:00.000
Edition1 st
Book TypePharmacology
Country of ManufactureIndia
Product BrandLAP LAMBERT Academic Publishing
Product Packaging InfoBox
In The Box1 Piece
Product First Available On ClickOnCare.com2015-10-08 00:00:00