Issue #5 2016 – Digital edition
20 October 2016 | By European Pharmaceutical Review
In this issue: Biosimilars, Informatics, Ingredients, PAT, HPLC, Microbiology, Product Showcase, Regulation, and much more...
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Articles
Product Showcase 2016
This product showcase features articles from Charles River, Eppendorf Inc. and Eurofins Lancaster Laboratories...
Ingredients In-Depth Focus 2016
In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle...
HPLC In-Depth Focus 2016
In this HPLC In-Depth Focus: Resolving natural compound complexity with multidimensional chromatography; The advantages of temperature elevations in HPLC...
Biosimilars: litigation outlook
In the Foreword article contributed by Consultant David P. Elder in Issue 3, 2016 of European Pharmaceutical Review, entitled ‘Biosimilars: future prospects’, Dr Elder concluded that it is likely that biosimilars will become increasingly established in both Europe and the United States and that in addition to proteins and peptides,…
Security considerations for external research
Intellectual Property (IP) is the lifeblood of the pharmaceutical industry. Without it, there would not be much of a business. Growing research and development globalisation, externalisation, the expansion of electronic data management systems and the lack of consistent global IP enforcement is increasing the capacity of external and internal parties…
At-line swabbing analysis as a process analytical tool
20 October 2016 | By Adeyinka Aina and Chris Edlin, Pharmaceutical Manufacturing Technology Centre
Swabbing is a technique commonly used during pharmaceutical cleaning protocols to ensure that the cleaning process meets both safety and regulatory requirements; this allows for the cleaning process to be subsequently verified and validated1-7.
Managing contamination risks in glove holes in barrier separation technology
The manufacture of sterile medicinal and therapeutic products increasingly calls for aseptic processing using barrier separation technology comprising isolators and restricted access barrier systems (RABS) that have glove-sleeve systems.
Understanding today’s drug pricing environment
In a healthcare world that experiences a plethora of high-cost new therapies coming to market in parallel with price increases for existing speciality drugs, pharmaceutical companies are having to move away from traditional pricing models that are largely based on demand and what the market will bear. At the same…
How Big Pharma’s money is affecting our health and our wallets
17 October 2016 | By Rebecca Hill, TheLawFirm.com
Read Injury Lawyer Rebecca Hill's review on how Big Pharma's money is affecting our health and our wallets and the suggestions for change...
Opening life sciences’ Unified Patent Court war chest
11 October 2016 | By Vanessa Rieu and Annsley Merelle Ward
Vanessa Rieu and Annsley Merelle Ward explain how life sciences companies can leverage their knowledge of national patent laws in a post-Brexit Europe...
Social media sourced Real World Evidence: A new wave in collecting data
3 October 2016 | By Peter Brady, CEO Orbital Media and Dr Martin Goldman, independent medical officer, Iatros Consulting
Dr Martin Goldman joins Peter Brady, Orbital Media's CEO, to discuss how to untap the potential of social media sourced real world evidence...
Pharmaceutical patents: Clear the way but careful where you tread
27 September 2016 | By Dominic Adair and Emma Muncey, Bristows
Top litigators Dominic Adair and Emma Muncey review patent court cases to identify the legal steps you should take when marketing a biosimilar...
Time to address the unmet need in women’s reproductive health
20 September 2016 | By Ernest Loumaye, MD, PhD, Co-Founder & Chief Executive Officer, ObsEva
Ernest Loumaye, PhD, Co-Founder & Chief Executive Officer of ObsEva discusses the unmet need of women's reproductive health and what's in the pipeline for treatment...
Antibiotics: resist the resistance
15 September 2016 | By Niamh Louise Marriott, Digital Content Producer
European Pharmaceutical Review caught up with Destiny Pharma’s CEO, Dr Love, for an exclusive interview to discuss why the pharmaceutical industry needs to radically change its approach to antibiotics in order to combat the threat of bacterial resistance…
