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Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
References for 'Availability of critical medicines during pandemics' and 'Approval of regulatory starting materials', in European Pharmaceutical Review Issue 5 2020.
Although steps have been taken to enable the implementation of continuous manufacturing in industry, a lack of global harmonisation in regulations has slowed the adoption of this promising emerging technology. Dave Elder discusses how ICH Q13 seeks to provide a harmonised approach to support this important initiative.
Repurposing existing drugs can be attractive as the process is often less risky, more cost effective and can be undertaken in less time. This article discusses the logic behind drug repurposing and the approaches that are currently being explored.
Adherence to medicines – ie, maintaining consistency and complying with correct dosage – is vital for treatment success, yet patient non-adherence remains a global concern, risking a multitude of consequences for both the patients and healthcare systems. Dave Elder explores the issue of medicine adherence and expounds on current efforts…
References for 'Drug repurposing', from European Pharmaceutical Review Issue 3 2020.
References for 'Patient adherence: the true costs', in European Pharmaceutical Review Issue 3 2020.
