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9780789001740

Medical Writing in Drug Development

by
  • ISBN13:

    9780789001740

  • ISBN10:

    0789001748

  • Format: Hardcover
  • Copyright: 1998-03-09
  • Publisher: Routledge

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Summary

A guide through the maze of the pharmaceutical research and development process, Medical Writing in Drug Development fills a gap in the libraries of technical writers, college instructors, and corporate professionals associated with the pharmaceutical process. As it discusses critical information, such as strategies and techniques pivotal to crafting documents for drug development, it also overviews drug research, document types, the roles of professional writers, and information technology. In no time at all, you will be creating persuasive technical documents, building complex facts into coherent messages, and contributing to the effective marketing of new products with promotional pieces that meet legal and ethical standards. Medical Writing in Drug Development helps medical writers and scientific, regulatory, and marketing professionals develop a working knowledge of the technical documents crucial to successful drug research. New and seasoned professional writers alike will benefit from the book's detailed discussions of: using abstracts, slides, and posters to present up-to-the-minute research how patient-education materials, health-economic assessments, and electronic journals provide ongoing challenges in medical writing a dossier approach that expedites regulatory submissions for international drug development structural constraints and rhetorical approaches toward regulatory documents presenting intricate information in scientifically unbiased, yet technically convincing language the effects of electronic publishing, computer graphics, and related technology on the practice of medical writing within pharmaceutical research Practical as a foundation text for undergraduate, graduate, and certificate programs in pharmaceutical or medical technical writing, Medical Writing in Drug Development will help you develop practical strategies for handling journal manuscripts, conference materials, and promotional pieces. No other text will clarify the main aspects of the pharmaceutical research and development process while offering you insight on the key issues dominating the healthcare arena.

Author Biography

Robert J. Bonk, PhD, now holds positions of Adjunct Assistant Professor at the Philadelphia College of Pharmacy and Science and in the University of Delaware's English Department.

Table of Contents

List of Figuresp. xi
List of Tablesp. xiii
Forewordp. xv
Prefacep. xvii
Acknowledgmentsp. xix
Medical Writing for Pharmaceutical Researchp. 1
Basic Introduction to Medical Writingp. 3
Historical Roots of Healthcare Communicationp. 3
Social Fabric of Medical Writingp. 5
Pharmaceutical Writing at the Forefrontp. 5
Overview of Drug Developmentp. 7
Regulation of the Drug Processp. 7
Sequence of Drug Developmentp. 8
Pharmacological Testing and Nonclinical Researchp. 9
Filing the Investigational New Drug Applicationp. 10
Protocols for Clinical Trialsp. 11
First Three Phases of Clinical Researchp. 12
Overview of a New Drug Applicationp. 14
Fourth Phase of Clinical Researchp. 15
Types of Pharmaceutical Documentsp. 17
Analysis of Document Audiencesp. 17
Regulatory Documents for Drug Submissionsp. 18
Publication Documents for the Medical Communityp. 20
Rhetorical Strategies for Pharmaceutical Documentsp. 21
Professional Roles of Medical Writersp. 25
Structure of Medical-Writing Groupsp. 25
Background, Skills, and Educationp. 26
Team Approach to Medical Writingp. 30
Publishing and Information Technologyp. 33
Electronic Publishing of Regulatory Documentsp. 33
Computerized Support for Publication Documentsp. 35
Future Implications of Information Technologyp. 36
Regulatory Documents for Drug Submissionsp. 39
Structure of Regulatory Submissionsp. 41
Pyramidal Structure of Regulatory Submissionsp. 41
Team Interactions for the Medical Writerp. 45
Foundation Reports of Research Trialsp. 47
Guidelines for Research Reportsp. 47
Clinical Trial Report as an Examplep. 48
Rhetorical Strategy of Research Reportsp. 49
Comparisons with Related Documentsp. 50
Overview and Summary Documentsp. 53
Overall Goals of Document Integrationp. 53
Rhetorical Approaches for Summary Documentsp. 55
Typical Examples as Document Modelsp. 56
Supportive Materials for Submissionsp. 59
Narrative Documents for Administrative Supportp. 59
Tabular Summaries That Compile Informationp. 61
Investigator's Brochure for Clinical Researchp. 62
Dossiers for International Projectsp. 67
Acceleration of Drug Developmentp. 67
Regulatory Submissions as an Emergent Dossierp. 68
Medical Writers and the Emergent Dossierp. 68
Publication Documents for the Medical Communityp. 71
Rhetorical Strategy for Publicationsp. 73
Types of Publication Documentsp. 73
Hooking the External Audiencep. 74
Authorship and Ethical Issuesp. 75
Manuscripts in Scientific Journalsp. 77
Key Aspects of Manuscript Preparationp. 77
Alternative Formats for Journal Submissionsp. 79
Ethical Issues for Journal Manuscriptsp. 80
Materials for Professional Meetingsp. 83
Abstracts Submitted for Acceptancep. 83
Slides and Posters for Presentationp. 84
Proceedings of the Overall Conferencep. 87
Ethical Concerns of Redundant Publicationp. 89
Promotional Pieces for Marketingp. 91
Promotion Within the Marketing Mixp. 91
Supportive Documents for Drug Promotionp. 92
Ethical and Legal Constraints on Promotionp. 94
Challenges of Broadening Audiencesp. 95
New Topics and New Media for New Audiencesp. 95
Ethical Responsibility for the Professionp. 96
Templates for Medical-Writing Documentsp. 99
Template for a Clinical Trial Reportp. 101
Template for an Overview Regulatory Documentp. 117
Template for a Publication Manuscriptp. 125
Referencesp. 129
Indexp. 135
Table of Contents provided by Syndetics. All Rights Reserved.

Supplemental Materials

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

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