Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics /
| Autor Corporativo: | |
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| Otros Autores: | , |
| Formato: | eBook |
| Lenguaje: | English |
| Publicado: |
Basel :
Birkhäuser Basel : Imprint: Birkhäuser,
2009.
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| Edición: | 1st ed. 2009. |
| Materias: |
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.