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E-book

Title Targeted regulatory writing techniques : clinical documents for drugs and biologics / edited by Linda Fossati Wood and MaryAnn Foote
Published Basel ; Boston : Birkhäuser, ©2009

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Description 1 online resource (x, 237 pages) : illustrations
Contents Developing a target; Regulatory writing tips; Templates and style guides: The nuts and bolts of regulatory documents; Document review; Protocols; Clinical study reports; Investigator's brochures; Investigational medicinal products dossier; Integrated summaries of safety and efficacy; Informed consent forms; Global submissions: The common technical document; Clinical trial procedures and approval processes in Japan; Region-specific submissions: United States of America
Summary Shows you how to approach the writing task in a logical process that permits rapid completion of writing. This book covers specific documents types, as well as submission to various major regions of the world
Notes Includes index
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Medical writing.
Industries.
Language and languages.
Social control.
Communication.
Sociology.
Social sciences.
Documentation.
Writing.
Pharmaceutical industry.
Information services.
Industry
Legislation, Drug
Language
Technology, Industry, and Agriculture
Investigative Techniques
Information Science
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Social Control, Formal
Communication
Technology, Industry, Agriculture
Sociology
Social Sciences
Anthropology, Education, Sociology and Social Phenomena
Documentation
Writing
Drug Approval
Drug Industry
Information Services
Drug Approval -- organization & administration
Drug and Narcotic Control
Language Arts
Evaluation Studies as Topic
Documentation -- methods
sociology.
social sciences.
documentation (activity)
writing (processes)
TECHNOLOGY & ENGINEERING -- Technical Writing.
Documentation -- methods.
Drug industry.
Writing.
Medical writing.
Drug Approval -- organization & administration.
Sciences de la vie.
Biomédecine.
Medical writing.
Forschungsbericht -- Arzneimittelforschung -- Gesundheitsverwaltung -- Ratgeber.
Arzneimittelforschung -- Forschungsbericht -- Gesundheitsverwaltung -- Ratgeber.
Gesundheitsverwaltung -- Arzneimittelforschung -- Forschungsbericht -- Ratgeber.
Genre/Form Electronic books
Form Electronic book
Author Wood, Linda Fossati
Foote, MaryAnn.
ISBN 9783764383626
3764383623