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註釋"This book concentrates on the writerly aspects of regulatory documentation and is intented to help the novice and to provide a refresher for more seasoned professionals. We collected advice and observations from professional experts working in industry, as consultants, at professional agencies, in contract research organizations and in academia. Their expertise spans all areas of regulatory writing, from chemistry, manufacturing and controls to clinical protocols to publications. Many of these experts emphasize not only the characteristics of high-quality writing but also the ethical and scientific benefits that accrue from keeping such practices in mind throughout research and development."--Avant-propos.