J Kähny-Simonius

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A brief overview of the relevant documents for companies in the pharmaceutical industry, which are to be taken into consideration to fulfil computer system validation requirements, is presented. We concentrate on official requirements and valid standards in the USA, European Community and Switzerland. There are basically three GMP-guidelines. their(More)
It is common practice in hospitals to administer drugs by infusion; thereby combinations of various drugs are frequent with respect to the patient's comfort and in order to save time. Various possibilities of combinations are presented and risks deriving from this form of application are discussed. In particular the risk for incompatibilities is emphasized(More)
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