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10 May 2017 | By Cristina Arnés, IFPMA Policy Analyst, Regulatory Policy and Economic Affairs
IFPMA's top analyst examines future trends, biotherapeutics and personalised medicine, and explains why the industry needs to examine its economic footprint...
3 May 2017 | By Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim
With biosimilars expected to account for 10% of the total biologics market by 2020, we caught up with Boehringer Ingelheim’s Senior VP to find out more…
The Directive on Falsified Medicines (FMD, or Directive 2011/62/EU amending Directive 2001/83/EC) and its supplementing Delegated Regulation (DR 2016/161) aim to improve patient safety by preventing falsified medicines from entering the legal supply chain...
European Pharmaceutical Review caught up with Richmond Pharmacology’s CEO, Dr Jorg Taubel, to talk pioneering UK based first-in-human clinical trials…
21 April 2017 | By Ben van der Schaaf, Principal at Arthur D. Little
Ben van der Schaaf explains how collaborative work can fund clinical trials of de-prioristised drugs and why pharma should consider partnering up...
Plastic materials used in pharmaceutical packaging can interact with the packaged dosage form, causing leachables to accumulate...
Guardino (2005) identified the first rapid microbiological method as a rapid plate count technique. This method was developed by Professor Frost...
Gas chromatography (GC) predates the more commonly utilised high performance liquid chromatography (HPLC). However, GC continues to enjoy some important niche applications in modern pharmaceutical analysis, such as the analysis of residual solvents or volatile organic compounds (VOCs)...
The concept of Quality by Design (QbD) was implemented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and United States Food and Drug Administration (FDA) around a decade ago, with the aim of adopting systematic approaches for developing high-quality pharmaceutical products for patients’…
Over 12 months ago, the European Union delegated regulation that supplements the Falsified Medicines Directive (FMD) was published in the Official Journal of the European Union, starting the countdown to the deadline of 9 February 2019, when most EU member-states, and three non-members currently, are expected to have implemented all…
Dr Rajendra Sharma argues the case for combining traditional healthcare with complementary and alternative medicine to create personal patient treatments...
Water is widely used in pharmaceutical manufacturing – either as a raw material, as an ingredient, or as a final product. Water is also used for rinsing equipment or for the preparation of disinfectants and detergents...
Biological products, usually referred to as biologics, constitute a significant segment of pharmaceuticals in development. Biologics include therapeutic proteins, antibody drugs, antibody-drug conjugates (ADCs), vaccines, carbohydrates drugs, blood and tissue-derived pharmaceuticals, gene therapies, even live cells and tissues...
Presented here are recommendations for performing an endotoxin masking hold-time study. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have requested hold-time studies to determine the presence of what has been called ‘low endotoxin recovery’ (LER) for submission with biologic licence applications (BLA)...
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