2009

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

Editors:

ISBN: 978-3-7643-8361-9 (Print) 978-3-7643-8362-6 (Online)

Table of contents (13 chapters)

  1. Front Matter

    Pages i-x

  2. Regulatory writing fundamentals

    1. Front Matter

      Pages 1-1

    2. No Access

      Book Chapter

      Pages 3-23

      Developing a target

  3. Getting started

    1. Front Matter

      Pages 25-25

    2. No Access

      Book Chapter

      Pages 27-32

      Regulatory writing tips

    3. No Access

      Book Chapter

      Pages 33-43

      Templates and style guides: The nuts and bolts of regulatory documents

    4. No Access

      Book Chapter

      Pages 45-50

      Document review

  4. Source documents

    1. Front Matter

      Pages 51-51

    2. No Access

      Book Chapter

      Pages 53-68

      Protocols

    3. No Access

      Book Chapter

      Pages 69-102

      Clinical study reports

  5. Integrated documents

    1. Front Matter

      Pages 103-103

    2. No Access

      Book Chapter

      Pages 105-119

      Investigator’s brochures

    3. No Access

      Book Chapter

      Pages 121-124

      Investigational medicinal products dossier

    4. No Access

      Book Chapter

      Pages 125-130

      Integrated summaries of safety and efficacy

    5. No Access

      Book Chapter

      Pages 131-137

      Informed consent forms

  6. Regulatory submissions

    1. Front Matter

      Pages 139-139

    2. No Access

      Book Chapter

      Pages 141-153

      Global submissions: The common technical document

    3. No Access

      Book Chapter

      Pages 155-174

      Clinical trial procedures and approval processes in Japan

    4. No Access

      Book Chapter

      Pages 175-185

      Region-specific submissions: United States of America

  7. Back Matter

    Pages 187-237