Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
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| Other Authors: | , |
| Format: | Electronic |
| Language: | English |
| Published: |
Basel :
Birkhũser Basel,
2009.
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| Subjects: | |
| Online Access: | https://ezaccess.library.uitm.edu.my/login?url=http://dx.doi.org/10.1007/978-3-7643-8362-6 |
Table of Contents:
- Regulatory writing fundamentals
- Developing a target
- 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<U+0019>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
- Appendix.