Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics /
Wood, Linda Fossati.
Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics / edited by Linda Fossati Wood, MaryAnn Foote. - recurso en línea.
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.
9783764383626
10.1007/9783764383626 doi
RM1-950
Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics / edited by Linda Fossati Wood, MaryAnn Foote. - recurso en línea.
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.
9783764383626
10.1007/9783764383626 doi
RM1-950