All Dave Elder (David P Elder Consultancy) articles
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ArticleICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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ArticleEuropean Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
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ArticleEuropean Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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ArticleEuropean Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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ArticleEuropean Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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ArticlePharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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ArticleEuropean Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
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ArticleNitrosamines: the beginning of the end?
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
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ArticleEuropean Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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ArticleEuropean Pharmaceutical Review Issue 3 2023
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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ArticleNITROSAMINES: Where now?
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
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ArticleEuropean Pharmaceutical Review Issue 1 2023
EPR Issue 1 includes articles on the future of pharmaceutical microbiology, separation and purification of complex biologics, the latest on nitrosamines and more...