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Pharmaceutical stability testing conference
Authors:Shi Li  Schofield Timothy
Institution:Merck & Co., Inc.
Abstract:The Pharmaceutical Stability Testing conference organised by SMi was held on the 8th and 9th of September 2003 in London. The focus of the conference was on stability testing issues related to both compound drugs and biopharmaceuticals and the impact of stability testing on product development and commercialisation. The conference brought two days of presentations given by formulation, process, analytical, quality and regulatory professionals from both the European and US pharmaceutical industries. The presentations discussed various issues related to pharmaceutical stability testing in early stage preclinical development, during clinical studies and in late stage development for regulatory filing. The discussions covered biologicals and small molecules, drug substance and drug product, with supporting case studies.
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