Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics [electronic resource] /edited by Linda Fossati Wood, MaryAnn Foote.
by Wood, Linda Fossati [editor.]; Foote, MaryAnn [editor.]; SpringerLink (Online service).
Material type:
BookPublisher: Basel : Birkhäuser Basel, 2009.Description: online resource.ISBN: 9783764383626.Subject(s): Medicine | Toxicology | Biotechnology | Pharmacy | Biomedicine | Pharmacology/Toxicology | Biotechnology | PharmacyDDC classification: 615 Online resources: Click here to access online
Contents:
In:
Springer eBooks
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.
| Item type | Current location | Call number | Status | Date due | Barcode |
|---|---|---|---|---|---|
| MAIN LIBRARY | RM1-950 (Browse shelf) | Available |
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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