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Guide To Testing
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
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Toxicology
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Novel two-chamber setup could predict HPAPI dustiness
A two-chamber setup (TCS) for containment investigations could predict the dustiness of HPAPIs in a sealed system at different flow conditions.
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Trends in biopharma contract manufacturing 2022
As biopharmaceuticals become an increasingly important part of the drug development pipeline and market, EPR discusses key trends in the outsourcing of their manufacturing.
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Improved outcome for prostate cancer patients in Phase III PROpel trial
Lynparza (Olaparib) in combination with abiraterone plus prednisone reduced the risk of disease progression or death by 34 percent in the Phase III PROpel trial for prostate cancer patients.
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Update on setting occupational exposure limits
Here, EPR summarises a recent review, outlining the critical considerations when setting occupational exposure limits (OELs), with a focus on HPAPIs.
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Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
whitepaper
Application note: Taxonomic traceability for bacterial and fungal entries in Accugenix® reference databases
When you are reviewing bacterial and fungal isolates, do you appreciate that the names given to these organisms are regulated?
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Quality driven solutions from discovery to commercialisation
We offer high quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation. Find out more in this guide…
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February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
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Improved in vitro renal tubular drug transport modelling to meet regulatory and development cost challenges
Due to the high costs associated with drug discovery and the clinical demand for effective drugs, in vitro human cell-based kidney models using renal proximal tubule epithelia are becoming popular tools for early-stage testing. It is increasingly more important that in vitro models of renal drug transport are physiologically representative…
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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
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COVID-19 vaccines to be monitored post-marketing by consortium in UK
The 'One Million Post-Authorisation Study' has been established to monitor the safety and effectiveness of COVID-19 vaccines in real-life conditions.
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Study suggests some excipients in common drugs are biologically active
Preliminary research has revealed that some excipients used in common medications may interact with important human enzymes and receptors.
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EMA issues guidance on medicine impurities, in light of nitrosamine detection
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
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Amneal recalls three nizatidine lots due to potential NDMA contamination
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
