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References

Dave Elder European Pharmaceutical Review references Issue 5 2020

20 October 2020 | By Dave Elder (David P Elder Consultancy)

References for 'Availability of critical medicines during pandemics' and 'Approval of regulatory starting materials', in European Pharmaceutical Review Issue 5 2020.

Five patent issues that European biosimilar developers should consider before entering the US market

25 June 2020 | By Grace Truong (Goodwin Procter LLP), Joshua Whitehill (Goodwin Procter LLP), Natasha Daughtrey (Goodwin Procter LLP)

References for 'Five patent issues that European biosimilar developers should consider before entering the US market', in European Pharmaceutical Review Issue 3 2020.

Drug repurposing

25 June 2020 | By Dave Elder (David P Elder Consultancy)

References for 'Drug repurposing', from European Pharmaceutical Review Issue 3 2020.

Patient adherence: the true costs

24 June 2020 | By Dave Elder (David P Elder Consultancy)

References for 'Patient adherence: the true costs', in European Pharmaceutical Review Issue 3 2020.

COVID-19: a wakeup call?

20 April 2020 | By Dave Elder (JPAG Member and David P Elder Consultancy)

References for 'COVID-19: a wakeup call?', in European Pharmaceutical Review Issue 2 2020.

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.

Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs

23 October 2019 | By Eric Ciappio (DSM)

References for 'Beyond nutrition: vitamins and n-3 polyunsaturated fatty acids as APIs', in European Pharmaceutical Review issue 5 2019.

Allowable levels of excipients in drug products

3 September 2019 | By Dave Elder (JPAG Member and David P Elder Consultancy), Fabio Faïs (Auris Medical)

References for 'Allowable levels of excipients in drug products', in European Pharmaceutical Review issue 4 2019.

Beyond API monitoring – Kaiser Optical Systems

9 February 2018 | By Kaiser Optical Systems

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

7 September 2017 | By European Pharmaceutical Review

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

7 September 2017 | By

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.…

Jenke D. Strategic aspects of change control. European Pharmaceutical Review. 2017;22(2):60-62

12 July 2017 | By Dennis Jenke

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

12 July 2017 | By Mostafa Eissa (Hikma Pharmaceuticals)

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

12 July 2017 | By

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…

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