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 ...
Axion BioSystems today announced that the FDA's Center for Drug Evaluation and Research (CDER) has accepted the company’s ...
Phasing out animal testing in preclinical drug trials in favor of unvalidated alternate methodologies could ultimately backfire and raise safety and effectiveness concerns, says Sara Gerke, the ...
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, ...
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 ...
Explore the debate surrounding animal testing as new methods may jeopardise patient safety if not properly validated.
DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs) ZURICH/SCHLIEREN, Switzerland, December 24, 2025 – DiNABIOS AG, ...
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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