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

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

The book contains black-and-white illustrations.

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

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.

Bonk, Robert J., PhD (Philadelphia Coll of Pharmacy and Science)