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Nitrosamine drug substance-related impurities (NDSRIs)
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.
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Dave Elder (David P Elder Consultancy)
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Manufacturing Classification System (MCS)
Here, David Elder elucidates the workings of the manufacturing classification system (MCS) used to guide decision making for drug formulators.
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Green chemistry
Here, Dave Elder reflects on the pharma industry’s efforts to get greener; highlighting the confounding issues that mean it is not always easy to achieve.
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The registration of novel excipients
Here, Dave Elder discusses some encouraging progress in the development of novel excipients, highlighting what this means for the industry.
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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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Nitrosamines: the latest position
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.
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Where now with quality by design?
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.
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Approval of regulatory starting materials
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…
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Availability of critical medicines during pandemics
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.
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Dave Elder European Pharmaceutical Review references Issue 5 2020
References for 'Availability of critical medicines during pandemics' and 'Approval of regulatory starting materials', in European Pharmaceutical Review Issue 5 2020.
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Continuous manufacturing: ICH Q13
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.
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The many advantages of repurposing existing drugs
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.
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Patient adherence: the true costs
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…
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Drug repurposing
References for 'Drug repurposing', from European Pharmaceutical Review Issue 3 2020.
