Last week’s round-up, 14 – 18 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Updated product-specific bioequivalence guidance 18 Oct 2019 The EMA has finalised product-specific bioequivalence guidance for seven drug substances. The substances affected are alectinib, apixaban, cabozantinib, colchicine, ezetimibe, gefitinib, and palbociclib. All guidances were adopted on 15 October 2019. Those for apixaban and gefitinib will become legally effective on […]

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« Le Penseur » vu sur son côté droit by Flickr user couscouschocolat

Last week’s round-up, 26-30 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud   Particulate Contamination: sub-visible particles in non-injectable liquid preparations 30 Aug 2019 A new draft chapter on particulate contamination by sub-visible particles in non-injectable liquid preparations has been released by the EDQM, within Pharmeuropa 31.4. Two methods through which such particulate contamination can be detected are specified within it: a light obscuration […]

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