Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

• Corporate Author: SpringerLink (Online service)
• Other Authors: Wood, Linda Fossati (Editor), Foote, MaryAnn (Editor)
• Format: Electronic eBook
• Language: English
• Published: Basel : Birkhäuser Basel, 2009.
• Subjects: Medicine.; Pharmacy.; Pharmacology.; Biotechnology.; Biomedicine.; Pharmacology/Toxicology.

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 th...