Regulating impurities in pharmaceutical products: a tolerability of risk approach?

作者: Frederic Bouder

DOI: 10.1586/17512433.1.2.241

关键词:

摘要: This paper explores the implications of EMEA guideline EMEA/CHMP/QWP/251344/2006 for pharmaceutical risk decisions. The guidelines propose to consider intake 1.5 µg/day a genotoxic impurity as 'threshold toxicological concern', and treat this level an acceptable (excess cancer <10(-5) over lifetime). guidance document also introduces specific decision-tree assess acceptability impurities. According decision-tree, when presence impurities is unavoidable, their levels should be reduced 'as low reasonably practicable' (ALARP). In UK, Health Safety Executive has developed 'tolerability risk' (ToR) model support ALARP requirements. compares risk-reduction requirements ToR model. risk-avoidance principle based on controversial interpretation 'pollution control'. supports view that not optimal from risk-management point view. Using could bring improvements decisions would more practical consensual approach meeting

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