Medical Writing in Drug Development

A Practical Guide for Pharmaceutical Research

Robert J Bonk (Autor)

Buch | Softcover

160 Seiten

1998
Routledge (Verlag)
978-0-7890-0449-9 (ISBN)

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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.

Robert J. Bonk

Contents
List of Figures

List of Tables
Foreword
Preface
Acknowledgments
PART I: MEDICAL WRITING FOR PHARMACEUTICAL RESEARCH
Chapter 1. Basic Introduction to Medical Writing
Historical Roots of Healthcare Communication
Social Fabric of Medical Writing
Pharmaceutical Writing at the Forefront
Chapter 2. Overview of Drug Development
Regulation of the Drug Process
Sequence of Drug Development
Pharmacological Testing and Nonclinical Research
Filing the Investigational New Drug Application
Protocols for Clinical Trials
First Three Phases of Clinical Research
Overview of a New Drug Application
Fourth Phase of Clinical Research
Chapter 3. Types of Pharmaceutical Documents
Analysis of Document Audiences
Regulatory Documents for Drug Submissions
Publication Documents for the Medical Community
Rhetorical Strategies for Pharmaceutical Documents
Chapter 4. Professional Roles of Medical Writers
Structure of Medical-Writing Groups
Background, Skills, and Education
Team Approach to Medical Writing
Chapter 5. Publishing and Information Technology
Electronic Publishing of Regulatory Documents
Computerized Support for Publication Documents
Future Implications of Information Technology
PART II: REGULATORY DOCUMENTS FOR DRUG SUBMISSIONS
Chapter 6. Structure of Regulatory Submissions
Pyramidal Structure of Regulatory Submissions
Team Interactions for the Medical Writer
Chapter 7. Foundation Reports of Research Trials
Guidelines for Research Reports
Clinical Trial Report as an Example
Rhetorical Strategy of Research Reports
Comparisons with Related Documents
Chapter 8. Overview and Summary Documents
Overall Goals of Document Integration
Rhetorical Approaches for Summary Documents
Typical Examples as Document Models
Chapter 9. Supportive Materials for Submissions
Narrative Documents for Administrative Support
Tabular Summaries That Compile Information
Investigator's Brochure for Clinical Research
Chapter 10. Dossiers for International Projects
Acceleration of Drug Development
Regulatory Submissions as an Emergent Dossier
Medical Writers and the Emergent Dossier
PART III: PUBLICATION DOCUMENTS FOR THE MEDICAL COMMUNITY
Chapter 11. Rhetorical Strategy for Publications
Types of Publication Documents
Hooking the External Audience
Authorship and Ethical Issues
Chapter 12. Manuscripts in Scientific Journals
Key Aspects of Manuscript Preparation
Alternative Formats for Journal Submissions
Ethical Issues for Journal Manuscripts
Chapter 13. Materials for Professional Meetings
Abstracts Submitted for Acceptance
Slides and Posters for Presentation
Proceedings of the Overall Conference
Ethical concerns of Redundant Publication
Chapter 14. Promotional Pieces for Marketing
Promotion Within the Marketing Mix
Supportive Documents for Drug Promotion
Ethical and Legal Constraints on Promotion
Chapter 15. Challenges of Broadening Audiences
New Topics and New Media for New Audiences
Ethical Responsibility for the Profession
APPENDIXES: TEMPLATES FOR MEDICAL-WRITING DOCUMENTS
Appendix A. Template for a Clinical Trial Report
Appendix B. Template for an Overview Regulatory Document
Appendix C. Template for a Publication Manuscript
References
Index

Verlagsort	New York
Sprache	englisch
Maße	148 x 210 mm
Gewicht	249 g
Themenwelt	Sachbuch/Ratgeber ► Gesundheit / Leben / Psychologie
Themenwelt	Medizin / Pharmazie
ISBN-10	0-7890-0449-6 / 0789004496
ISBN-13	978-0-7890-0449-9 / 9780789004499
Zustand	Neuware