Dave Elder (David P Elder Constultancy)

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Patents: a necessary evil?

19 October 2022 | By Dave Elder (David P Elder Constultancy)

Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.

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API nitrosamines: method sensitivity issues

25 August 2022 | By Dave Elder (David P Elder Constultancy)

Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.

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Paediatric medicines: just a spoonful of sugar?

26 August 2021 | By Dave Elder (David P Elder Constultancy)

Here, Dave Elder discusses the ever increasing importance of child-friendly medications and the specific challenges associated with their development.

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ICH M13: Bioequivalence guidelines

29 June 2021 | By Dave Elder (David P Elder Constultancy)

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

20 April 2021 | By Dave Elder (David P Elder Constultancy), Stacey Treichler (Catalent)

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

17 February 2021 | By Dave Elder (David P Elder Constultancy)

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

29 January 2020 | By Dave Elder (David P Elder Constultancy)

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

24 February 2017 | By Dave Elder (David P Elder Constultancy)

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...