Medical Writing in Drug Development : A Practical Guide for Pharmaceutical Research

ISBN-13: 9780789004499 / Angielski / Miękka / 1998 / 139 str.

Robert J. Bonk

Opis

Use this practical guidebook to help you tackle the challenges that medical writing presents Chosen as one of the Best Books of the Year by Doody's Journal, Medical Writing in Drug Development will help readers create effective marketing and advertising pieces on medical topics, especially pharmacy research, that meet legal and ethical standards. Readers will find tips and strategies for developing informative patient-education materials, health-economic assessments, research reports, and conference materials that contain comprehensive and important facts. This helpful book also discusses using computer graphics and related technology to make eye-opening advertisements and examines the effects of electronic publishing on medical research writing. In no time at all, readers will be developing persuasive promotions and articles that relay facts and figures in a clear, comprehensive, and impressive fashion.

Spis treści

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

O autorze

Robert J. Bonk