More guidance is needed on the appropriate control of non-mutagenic impurities during clinical development, explains Dave P Elder, JPAG Member and pharmaceutical industry consultant, in this audio interview.
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9 July 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
As part of EPR’s Women inspiring Pharma series, Gowri Sukumar, Associate Director, CMC and Regulatory Affairs at ESSA Pharmaceuticals, talks to Science Editor Dr Zara Kassam about having a positive mindset, diversity and the key to success…
18 June 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
As part of EPR’s Women inspiring Pharma series, Liz Barrett, CEO Oncology, Novartis, talks to Science Editor Dr Zara Kassam about finding cures for cancer, identifying meaningful partnerships and acknowledging unconscious biases…
7 June 2018 | By European Pharmaceutical Review
The General Data Protection Regulation (GDPR) is a new set of EU rules governing how a company manages, protects and administers personal data. Whether you are a subscriber, author, advertiser or supplier to our journal, we may hold information about you and we need to keep it private and secure.
Two-dimensional liquid chromatography (2D-LC) has obtained increasing focus over the past two decades. At LEO Pharma, we continuously evaluate new laboratory techniques with the potential to advance our drug discovery and development. We installed a MHC 2D-LC 18 months ago and have found it valuable in a broad range of…
17 May 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
As part of EPR’s Women in Pharma series, Claudia Geis, Head of Region Europe, Ascensia Diabetes Care, talks to Science Editor Dr Zara Kassam about returning to work after maternity leave, setting expectations within a team and sticking to your values…
Developing serialisation programmes is a key concern for pharmaceutical companies. Much of the decision-making is being driven by fast-approaching deadlines for compliance - both in the EU and US.
26 April 2018 | By Kevin L Williams - bioMerieux
Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP .
Pyrogen testing of drug products for parenteral administration is a mandatory task. Regulatory authorities require that each batch of drug product is pyrogen-free. Historically, the rabbit pyrogen test (RPT) was the required test but in most cases can be replaced by the endotoxin specifi c Limulus Amebocyte Lysate (LAL) test.
26 April 2018 | By Jeanne Moldenhauer
There have been many changes in pharmaceutical microbiology as we progressed into the 21st century. Some of these changes have been due to the advance of rapid microbiological methods, knowledge gained from the study of the human microbiome, while others are changes to conventional testing methods. This paper discusses some…