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Quality by Design aspects applied to Clinical Study Protocol Development

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MANFRED STAPFF
Actavis plc, Quality Management Systems, Standards & Training, Jersey City, NJ, USA
Quality by Design aspects applied to Clinical Study Protocol Development

INTRODUCTION
Clinical Study Protocols are the prospective blueprints for the execution of a scientific experiment involving human subjects. A clinical study intends to answer a scientific question and aims to contribute with new information to the current knowledge base in the medical / scientific community. Such knowledge can be used by regulatory agencies in their decision to approve a new drug, by medical associations to feed into revised treatment guidelines, or - if they are hypothesis generating rather than confirming - as a basis to plan further experiments.
A clinical study always poses a certain risk to participants, because - by definition - not all positive or negative effects of the study drug are well known and understood (if they were, the stud