Drug safety

Mitochondrial dysfunction is known to play a central role in drug-induced hepatotoxicity, and thus early detection of mitochondrial toxicity is a critical component of initial drug development efforts. While immortalised cell lines are widely used for in vitro assessment of hepatotoxicity, cryopreserved primary human hepatocytes are a preferred model for drug safety screening. Download this new […]

Mitochondrial dysfunction is known to play a central role in drug-induced hepatotoxicity, and thus early detection of mitochondrial toxicity is a critical component of initial drug development efforts. While immortalised cell lines are widely used for in vitro assessment of hepatotoxicity, cryopreserved primary human hepatocytes are a preferred model for drug safety screening. In this App […]

A tiny human heart model could potentially transform cardiovascular research and enable animal-free drug testing. A team of researchers, led by the Hebrew University of Jerusalem (HU), has developed a self-paced, multi-chambered human heart model, approximately half the size of a rice grain. “Integrating our complex human heart model with sensors allowed us to monitor […]

In a DDW Sitting Down With podcast with Lu Rahman, Ruth Roberts and Claire Sadler, ApconiX, discuss the benefits of performing a target safety assessment (TSA) during drug discovery and development when a biological target is going to be acted on by a drug. The background In this podcast, Professor Ruth Roberts, co-Founder of ApconiX, […]

The European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing data on the risk of suicidal thoughts and thoughts of self-harm related to GLP-1 receptor agonists. The drugs under review include Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), used for weight loss and for treating type 2 diabetes. The review […]

The latest sponsored DDW Sitting Down With podcast is now live. Professor Ruth Roberts, Co-Founder ApconiX, and Claire Sadler, Project Toxicologist, discuss the benefits of carrying out a target safety assessment (TSA) during drug discovery and development whenever a biological target is going to be modulated. The speakers outline how TSAs can be used throughout the […]

In the latest sponsored DDW Sitting Down With podcast Professor Ruth Roberts, Co-Founder ApconiX, and Claire Sadler, Project Toxicologist, discuss the benefits of carrying out a target safety assessment (TSA) during drug discovery and development whenever a biological target is going to be modulated. The speakers outline how TSAs can be used throughout the drug discovery […]

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden1 – the Modernization Act 2.0. This news has been shared widely as a landmark moment, especially in the eyes of animal welfare organisations but […]

New research, involving 200 professionals in senior roles spanning pharmacovigilance (PV), Drug Safety and Product Safety departments, has found that quality has overtaken cost as a priority in plans for automating adverse event (AE) reporting. John Price, life sciences industry consultant and partner of Arriello, which commissioned this latest research, reports on the findings.  Although the Covid-19 pandemic has stalled progress with digital process […]

Effective preclinical assessment of drug safety and efficacy is essential to help reduce the risk of drug-induced toxicity and late-stage drug attrition. Current preclinical tests for safety depend on in vivo testing in higher-order species to achieve translational accuracy; however, animal models are expensive and do not adequately recapitulate human physiology due to species differences. […]

Effective preclinical assessment of drug safety and efficacy is essential to help reduce the risk of drug-induced toxicity and late-stage drug attrition. Current preclinical tests for safety depend on in vivo testing in higher-order species to achieve translational accuracy; however, animal models are expensive and do not adequately recapitulate human physiology due to species differences. […]