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The ever-increasing demand for cannabis-based products requires US state regulators to set guidelines that ensure products are safe for human use. However, as medicinal cannabis moves forward at a rapidly increasing pace, regulations are falling behind. Here, Robert Thomas discusses the many inconsistencies across US states for monitoring levels of…
The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.
In this guide to Analytical Testing, SUEZ explains how to maximise efficiency without compromising on quality.
After a review of cyproterone, the EMA has recommended that the drug only be prescribed once other treatment options have failed, due to an increased meningioma risk.
A collaborative effort between the FDA and Government of India stopped shipments of illegal drugs from reaching patients in the US in Operation Broadsword.
19 February 2020 | By SUEZ
Watch our on-demand webinar which will guide you through efficiency gains with TOC for cleaning validation. We call it a ‘beginner’s guide’, but this webinar will benefit long-time TOC users as well as those new to using TOC for cleaning validation.
Dr Finn Bauer discusses how Merck KGaA and its SAFC® portfolio brand is addressing drug formulator challenges.
Within this in-depth focus are articles on how the regulation of heavy metals in cannabis can benefit from lessons learned in pharma and the advantages of using electron paramagnetic resonance (EPR) as an imaging technique.
A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
European Pharmaceutical Review attended a JPAG event, exploring the plethora of uses for in silico techniques in the pharmaceutical industry.
A facility has opened in Ireland which will allow the biopharma industry to trial and simulate the latest bioprocessing and quality control technologies in a GMP environment.
Within this issue are articles which investigate polyelectrolyte multilayers as drug carriers, discuss how developments in pharma impact logistics and examine how the industry can regulate heavy metals in medicinal cannabis. Other features include how to use the correct tablet tooling and trends for the CDMO sector this year.
After clinical trials showed an increased risk of cancer in patients taking Belviq, the FDA has recommended the withdrawal of the drug from the US market.
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
This whitepaper from NSF looks at the key causes of drug shortages and what we can do to stop them.
