Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

This book describes the authors' standard or 'best' practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Wood, Linda Fossati (Editor ), Foote, MaryAnn (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Basel : Birkhäuser Basel : Imprint: Birkhäuser, 2009.
Edición:1st ed. 2009.
Temas:
Pharmacology.
Biotechnology.
Pharmacy.
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Regulatory writing fundamentals
  • Developing a target
  • Getting started
  • Regulatory writing tips
  • Templates and style guides: The nuts and bolts of regulatory documents
  • Document review
  • Source documents
  • Protocols
  • Clinical study reports
  • Integrated documents
  • Investigator's brochures
  • Investigational medicinal products dossier
  • Integrated summaries of safety and efficacy
  • Informed consent forms
  • Regulatory submissions
  • Global submissions: The common technical document
  • Clinical trial procedures and approval processes in Japan
  • Region-specific submissions: United States of America.

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