Medical Writing in Drug Development

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