Catalog

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics [electronic resource]

  • Wood, Linda Fossati. editor. , Foote, MaryAnn. editor.
  • 2009
Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics [electronic resource]
  • Data Type
    Book
  • Title/Author
    Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics[electronic resource] / edited by Linda Fossati Wood, MaryAnn Foote.
  • Author
    Wood, Linda Fossati., editor., Foote, MaryAnn., editor.
  • Authors
    SpringerLink (Online service)
  • Phy Desc.
    X, 238 p. 26 illus. : online resource.
  • Contents Note
    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?셲 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.
  • Topical Term
    Medicine.
    Pharmacy.
    Pharmacology.
    Biotechnology.
    Biomedicine.
    Pharmacology/Toxicology.
    Biotechnology.
    Pharmacy.
  • Host Item
    Springer eBooks
  • Additional Item
    Printed edition: 9783764383619
  • ISBN
    9783764383626
  • Language
    English