Review of Targeted Regulatory Writing Techniques
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Review of Targeted Regulatory Writing Techniques
Stern F. Lff, PhD HoffConsulting, LLC
Corrospo~demc~ Addross Steven Hoff, PhD* Hoff Consulting, LLC 412 Witchwood Lane, Luke Bluff, IL 60044 (mail: [email protected]).
LINDA FOSSATI WOOD AND MARYANN p m , EDS.: TARGETED
REGULATORY WRZT.ING TECHNIQUES: CLINICAL DOCUMENTS FOR DRUGS AND BIOLOGICS. Base1 BirkhPuser Verlag; 2009. 237 pp., paperback Excellent medical writing is key to the success of regulatory submissions, and much of the training for medical and regulatory writers is by experience on the job. The editors of Targeted Regulatory Writing Techniques have assembled a very useful book for their specific audience, the novice medical writer. The scope of the book is primarily regulatory writing of the clinical documents and clinical sections of regulatory submissions for drugs and biologics in the context of the European Union, Japan, and the United States, though the main focus of the book is on documents for the United States. This book is written by eight authors and comprises l3 chapters, covering five broad topics: regulatory writing fundamentals, getting started, source documents, integrated documents, and regulatory submissions. The second section includes chapters on regulatory writing tips, templates and style guides, and document review. These chapters are most useful to the novice writer, as they discuss information not
found in the various guidance documents available from regulatory agencies. The authors have used their years of experience to express the need for planning and working with various functions within an organization. They also discuss the logical flow and streamlining of document text, and how to utilize document templates and style guides to ensure consistent presentation of information for regulatory reviewers. The next chapters on source documents discuss clinical protocols and study reports, which provide some ideas on organization and important items within the documents. Another useful feature the authors provide is the "Sidebar: Lessons Learned" boxes within most chapters, which emphasize certain aspects of a document or process. The discussion of integrated documents is found in chapters 7 through 10.The chapter on the investigator's brochure (IB) is written well. The author suggests on page 109 that the size of the IB should be approximately 50 pages. While this is desirable, it certainly should not be taken as a required size, since IBs vary quite extensively, depending on the drug product in question and its status of development. Some drug products have extensive databases, consisting of nonclinical and perhaps multiple clinical trials, making it difficult to limit the size of the 1B. These documents can grow to 200 pages after
Journal, Vd.43. pp. 633434,2009 0092-8615/2009 Downloaded from dij.sagepub.com at PURDUE LIBRARYAsson'ation. TSS on May 24, 2015 Printed in the USA. AN rights mcrved. Cov'ght 0 2009 DrugUNIV Information Inc.
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BOOK REVIEW
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