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List of Figures | p. xi |
List of Tables | p. xiii |
Foreword | p. xv |
Preface | p. xvii |
Acknowledgments | p. xix |
Medical Writing for Pharmaceutical Research | p. 1 |
Basic Introduction to Medical Writing | p. 3 |
Historical Roots of Healthcare Communication | p. 3 |
Social Fabric of Medical Writing | p. 5 |
Pharmaceutical Writing at the Forefront | p. 5 |
Overview of Drug Development | p. 7 |
Regulation of the Drug Process | p. 7 |
Sequence of Drug Development | p. 8 |
Pharmacological Testing and Nonclinical Research | p. 9 |
Filing the Investigational New Drug Application | p. 10 |
Protocols for Clinical Trials | p. 11 |
First Three Phases of Clinical Research | p. 12 |
Overview of a New Drug Application | p. 14 |
Fourth Phase of Clinical Research | p. 15 |
Types of Pharmaceutical Documents | p. 17 |
Analysis of Document Audiences | p. 17 |
Regulatory Documents for Drug Submissions | p. 18 |
Publication Documents for the Medical Community | p. 20 |
Rhetorical Strategies for Pharmaceutical Documents | p. 21 |
Professional Roles of Medical Writers | p. 25 |
Structure of Medical-Writing Groups | p. 25 |
Background, Skills, and Education | p. 26 |
Team Approach to Medical Writing | p. 30 |
Publishing and Information Technology | p. 33 |
Electronic Publishing of Regulatory Documents | p. 33 |
Computerized Support for Publication Documents | p. 35 |
Future Implications of Information Technology | p. 36 |
Regulatory Documents for Drug Submissions | p. 39 |
Structure of Regulatory Submissions | p. 41 |
Pyramidal Structure of Regulatory Submissions | p. 41 |
Team Interactions for the Medical Writer | p. 45 |
Foundation Reports of Research Trials | p. 47 |
Guidelines for Research Reports | p. 47 |
Clinical Trial Report as an Example | p. 48 |
Rhetorical Strategy of Research Reports | p. 49 |
Comparisons with Related Documents | p. 50 |
Overview and Summary Documents | p. 53 |
Overall Goals of Document Integration | p. 53 |
Rhetorical Approaches for Summary Documents | p. 55 |
Typical Examples as Document Models | p. 56 |
Supportive Materials for Submissions | p. 59 |
Narrative Documents for Administrative Support | p. 59 |
Tabular Summaries That Compile Information | p. 61 |
Investigator's Brochure for Clinical Research | p. 62 |
Dossiers for International Projects | p. 67 |
Acceleration of Drug Development | p. 67 |
Regulatory Submissions as an Emergent Dossier | p. 68 |
Medical Writers and the Emergent Dossier | p. 68 |
Publication Documents for the Medical Community | p. 71 |
Rhetorical Strategy for Publications | p. 73 |
Types of Publication Documents | p. 73 |
Hooking the External Audience | p. 74 |
Authorship and Ethical Issues | p. 75 |
Manuscripts in Scientific Journals | p. 77 |
Key Aspects of Manuscript Preparation | p. 77 |
Alternative Formats for Journal Submissions | p. 79 |
Ethical Issues for Journal Manuscripts | p. 80 |
Materials for Professional Meetings | p. 83 |
Abstracts Submitted for Acceptance | p. 83 |
Slides and Posters for Presentation | p. 84 |
Proceedings of the Overall Conference | p. 87 |
Ethical Concerns of Redundant Publication | p. 89 |
Promotional Pieces for Marketing | p. 91 |
Promotion Within the Marketing Mix | p. 91 |
Supportive Documents for Drug Promotion | p. 92 |
Ethical and Legal Constraints on Promotion | p. 94 |
Challenges of Broadening Audiences | p. 95 |
New Topics and New Media for New Audiences | p. 95 |
Ethical Responsibility for the Profession | p. 96 |
Templates for Medical-Writing Documents | p. 99 |
Template for a Clinical Trial Report | p. 101 |
Template for an Overview Regulatory Document | p. 117 |
Template for a Publication Manuscript | p. 125 |
References | p. 129 |
Index | p. 135 |
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The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.