Open AccessScience and Quality Assurance: From dose to overdose
Author(s) -
Jones Anthony B.
Publication year - 2004
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.284
Subject(s) - quality assurance , quality (philosophy) , process (computing) , engineering ethics , drug development , risk analysis (engineering) , medicine , engineering management , drug , engineering , process management , management science , pharmacology , computer science , operations management , epistemology , philosophy , external quality assessment , operating system
For Quality Assurance to be a proactive partner in drug development we need to understand the scientific concepts that define and shape the pharmaceutical process. Drug development can be more easily understood by considering the basic scientific principles governing the numerous scientific disciplines that contribute to producing safe and effective drugs. This article describes how two of these principles influence drug development from choice of molecule through to clinical testing and how they interact with FDA regulations and Quality Assurance. Copyright © 2004 John Wiley & Sons, Ltd.