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This book contains an overview of the scientific and regulatory requirements for stabilty testing including the draft of the harmonised guideline for the stability testing in the EC, Japan and the USA. Therefore it will possible to carry out stability testing in the most efficient way. This book may be of interest to scientists - in the field of drug development in pharmaceutical industries - responsible for drug registration - responsible for quality control - at universities
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Stability testing in the EC, Japan and the USA, Wolfgang Grimm
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- 1993
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