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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
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Description for Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
Paperback. Shows you how to approach the writing task in a logical process that permits rapid completion of writing. This book covers specific documents types, as well as submission to various major regions of the world. Editor(s): Wood, Linda Fossati; Foote, Maryann. Num Pages: 238 pages, 26 black & white illustrations, 96 black & white tables, biography. BIC Classification: CBWT; MBPM; MMG. Category: (P) Professional & Vocational. Dimension: 240 x 171 x 14. Weight in Grams: 434.
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective ... Read more
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective ... Read more
Product Details
Format
Paperback
Publication date
2008
Publisher
Birkhäuser
Condition
New
Number of Pages
238
Place of Publication
Basel, Switzerland
ISBN
9783764383619
SKU
V9783764383619
Shipping Time
Usually ships in 15 to 20 working days
Ref
99-15
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