Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics - Wood, Linda Fossati; Foote, MaryAnn; SpringerLink (Online service) (Basel : Birkhäuser Basel : Imprint: Birkhäuser, 2009)
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.
Keywords: Pharmacology; Biotechnology; Pharmacy; Pharmacology/Toxicology.; Biotechnology; Pharmacy