Articles liés à Ethical Guideline on Paediatric Drug Development; Regulatory...

Ethical Guideline on Paediatric Drug Development; Regulatory Aspects: Principles And Practice of Paediatric Clinical Studies - Couverture souple

Ashawat, Mahendra Singh; Hada, Nilima Kanwar

 
9783659494864: Ethical Guideline on Paediatric Drug Development; Regulatory Aspects: Principles And Practice of Paediatric Clinical Studies
Couverture souple
ISBN 10 : 3659494860 ISBN 13 : 9783659494864
Editeur : LAP LAMBERT Academic Publishing, 2013

Synopsis

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)

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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)

Biographie de l'auteur

Dr. Mahendra Singh Ashawat is working as Professor and Dean (Academics) in Rungta College of Pharma. Sciences & Research, Bhilai. Dr. Ashawat is amongst the foremost Pharmacy teacher in second generation of Rajasthan Pharmacy Education. He had his education at Dr. H.S.gaur University Sagaur(MP) and Pandit Ravishankar Shukla University Raipur(CG).

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2013
Langue
anglais
ISBN 10 
3659494860
ISBN 13 
9783659494864
Reliure
Broché
Nombre de pages
252
Coordonnées du fabricant
non disponible
Personne responsable
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