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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Five patent issues that European biosimilar developers should consider before entering the US market
References for 'Five patent issues that European biosimilar developers should consider before entering the US market', in European Pharmaceutical Review Issue 3 2020.
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.
References for 'COVID-19: a wakeup call?', in European Pharmaceutical Review Issue 2 2020.
References for 'The role of ELSIE in evolving current thinking on extractables and leachables', in European Pharmaceutical Review issue 1 2020.
References for 'Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs', in European Pharmaceutical Review issue 5 2019.
References for 'Allowable levels of excipients in drug products', in European Pharmaceutical Review issue 4 2019.
Esmonde-White, K. A., Cuellar, M., Uerpmann, C., Lenain, B., & Lewis, I. R. Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing. Anal. Bioanal. Chem. 409, 637–649 (2016). Strachan, C. J., Rades, T., Gordon, K. C. , & Rantanen, J. Raman spectroscopy for quantitative analysis of pharmaceutical…
Moore R, Cubbon S, Blank M, Bones J. Is high resolution mass spectrometry the missing piece in continuous bioproduction?
7 September 2017 | By
REFERENCES 1. Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004). Accessed online 27/06/2017. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm0 70305.pdf. 2. Adamo A, et al. On‐demand continuous‐flow production of pharmaceuticals in a compact, reconfigurable system. Science. 2016;357(6281):61‐67. 3. Walther J, et al. The business impact of an…
Fahrzi B, Cetinkaya C. Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. 2017;22(4):36-40
REFERENCES 1. Rodriguez ML, McGarry PJ, Sniadecki NJ. Review on cell mechanics: experimental and modeling approaches. Applied Mechanics Reviews. 2013;65:060801. 2. Johnson KL, Kendall K, Roberts AD. Surface energy and the contact of elastic solids. Proceedings of the Royal Society of London A: Mathematical, Physical and Engineering Sciences. The Royal…
Panofen D, Pandolfi D, Denoya C. Compressed gases: an important component of an environmental monitoring programme. 2017;22(4):16-20
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References (2013). Microbiological Control and Monitoring of Aseptic Processing Environments. Chapter <1116>. 784-794. Rockville, MD, USA. Denoya C, Reyes J, Ganatra M, Eshete D. Rapid Sterility Testing using ATP Bioluminescence-based PallChek Rapid Microbiology System. Rapid Sterility Testing (J. Moldenhauer Ed.). 2011. Chapter 17, 433-461, DHI/PDA. Bethesda, MD, USA. Denoya C.…
References Arbin A, Jacobsson S, Hanninen K, Hagman A, Ostelius J. Studies on the contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques. Int J Pharm. 1986;28(2-3):211-218. Goydan R, Schwope AD, Redi RC, Cramer G. High-temperature migration of anti-oxidants from polyolefins. Food Additives and Contaminants.…
Eissa M. Microorganisms and a new horizon of scientific discoveries. European Pharmaceutical Review. 2017;3:68-70
References 1. Madigan M, Martinko J, Parker J. Brock biology of microorganisms. Upper Saddle River, NJ: Prentice Hall/Pearson Education; 2003. 2. Extremophilic Bacteria and Microbial Diversity [Internet]. Mhhe.com. 2016 [cited 21 July 2016]. Available from: www.mhhe.com/biosci/genbio/raven6b/graphics /raven06b/enhancementchapters/raven30_enhancement.html 3. Muruga, Bancy N. The diversity of extremophilic bacteria in Lake Magadi, Kenya.…
Miller M. The regulatory acceptance of rapid microbiological methods. European Pharmaceutical Review. 2017;3:55-58
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References European Medicines Agency. Inspectors Working Group. Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. EMA/INS/GMP/489331/2016 GMP/GDP. 2016. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211657.pdf Alternative Methods for Control of Microbiological Quality, European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa. 2017; Chapter…