After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
Explore the debate surrounding animal testing as new methods may jeopardise patient safety if not properly validated.
Although new approach methodologies (NAMs) are not that new, they remain a crucial and evolving aspect of the development and production of biopharmaceuticals. “NAMs have been around for 20 years plus ...
As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, ...
Axion BioSystems’ Letter of Intent for its Human iPSC-Cardiomyocyte MEA Assay for Prediction of Clinical Cardiovascular ...
New approach methodologies (NAMs) – such as organoids, spheroids and microfluidic chip systems – aim to streamline early-stage drug discovery and revolutionize preclinical testing by augmenting ...
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