Medical Writing in Drug Development; A Practical Guide for Pharmaceutical Research / Edition 1

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Overview

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.

The book contains black-and-white illustrations.

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Editorial Reviews

Doody's Review Service
Reviewer: Mary Lynn Moody, BSPharm (University of Illinois at Chicago College of Pharmacy)
Description: This book provides an in-depth review of pharmaceutical writing and the role of the medical writer.
Purpose: The purpose is to provide a guide that can be used when teaching the concepts of pharmaceutical writing as it pertains to drug development. In addition, this is a useful reference for medical writers wishing to expand into the area of pharmaceutical research.
Audience: This book is targeted primarily at those beginning in the field of pharmaceutical writing or those teaching medical writing in university coursework. It would also be useful to scientific, regulatory, and marketing professionals within the pharmaceutical industry to understand technical writing in the drug research process.
Features: This text is divided into three sections. The first section is a general overview of medical writing and the role of the medical writer in the pharmaceutical industry. The second section focuses on the variety of regulatory documents that are necessary in preparing drug submissions. The third section focuses on the types of external writing needed for the medical community including journal publications, marketing pieces, and promotional material. Throughout, the reader is reminded of the ethical considerations of medical writing and their impact on science. Templates for a clinical trial report, an overview regulatory document, and a journal publication are included. These are very useful to students and practitioners attempting to create these complex documents.
Assessment: This is an extremely useful reference for pharmaceutical writing. It provides a practical guide for the new medical writer. It is well organized and easy to follow for students learning medical writing skills. It would be a valuable asset to other professionals in the pharmaceutical industry involved in drug development projects.
Mary Lynn Moody
This book provides an in-depth review of pharmaceutical writing and the role of the medical writer. The purpose is to provide a guide that can be used when teaching the concepts of pharmaceutical writing as it pertains to drug development. In addition, this is a useful reference for medical writers wishing to expand into the area of pharmaceutical research. This book is targeted primarily at those beginning in the field of pharmaceutical writing or those teaching medical writing in university coursework. It would also be useful to scientific, regulatory, and marketing professionals within the pharmaceutical industry to understand technical writing in the drug research process. This text is divided into three sections. The first section is a general overview of medical writing and the role of the medical writer in the pharmaceutical industry. The second section focuses on the variety of regulatory documents that are necessary in preparing drug submissions. The third section focuses on the types of external writing needed for the medical community including journal publications, marketing pieces, and promotional material. Throughout, the reader is reminded of the ethical considerations of medical writing and their impact on science. Templates for a clinical trial report, an overview regulatory document, and a journal publication are included. These are very useful to students and practitioners attempting to create these complex documents. This is an extremely useful reference for pharmaceutical writing. It provides a practical guide for the new medical writer. It is well organized and easy to follow for students learning medical writing skills. It would be a valuable asset toother professionals in the pharmaceutical industry involved in drug development projects.
Booknews
Details a college-level course on pharmaceutical writing. The discussion of the regulatory documents that comprise drug submissions stresses commonalities and differences between research reports, summary documents, and supportive materials. Other topics include drug research, document types, external publications for the medical community, and appropriate rhetorical strategies for journal manuscripts, conference materials, and promotional pieces. Paper edition 0449-6, $19.95. Annotation c. by Book News, Inc., Portland, Or.

4 Stars! from Doody
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Product Details

  • ISBN-13: 9780789004499
  • Publisher: Taylor & Francis
  • Publication date: 2/28/1998
  • Edition number: 1
  • Pages: 139
  • Product dimensions: 6.00 (w) x 8.20 (h) x 0.50 (d)

Table of Contents

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
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