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Paediatric medicines: just a spoonful of sugar?
Here, Dave Elder discusses the ever increasing importance of child-friendly medications and the specific challenges associated with their development.
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Dave Elder (David P Elder Constultancy)
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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Antibody-drug conjugates: challenges, solutions and future potential
The ability to precisely direct powerful therapeutics not only makes treatments more effective, but also prevents debilitating side effects. Here, Dave Elder and Stacey Treichler highlight the great potential of antibody-drug conjugates (ADCs) for improved treatment of oncology indications and beyond.
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Sourcing of active pharmaceutical ingredients
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
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The role of ELSIE in evolving current thinking on extractables and leachables
References for 'The role of ELSIE in evolving current thinking on extractables and leachables', in European Pharmaceutical Review issue 1 2020.
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Monitoring and controlling drug products and manufacturing processes with NIRS
Near-infrared spectroscopy (NIRS) is a rapid and non-destructive analytical technique that is important in analysing or profiling both solid and liquid dosage forms, as well as biotechnological products...