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 and strategy th...
| Autor Corporativo: | |
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| Otros Autores: | , |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Basel :
Birkhäuser Basel
2009.
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| Colección: | Springer eBooks.
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| Acceso en línea: | Conectar con la versión electrónica |
| Ver en Universidad de Navarra: | https://innopac.unav.es/record=b32696838*spi |
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.
