Phasing out animal testing in preclinical drug trials in favor of unvalidated alternate methodologies could ultimately ...
In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
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 ...
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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 ...
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging ...
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
Despite new methodologies and flexible regulatory pathways, CNS biopharmaceuticals still face significant safety assessment ...
With distribution agreements with JCBio and Tekon Biotech in place, NAMKind™ liver and small intestine toxicology services are now available via local distributor engagement across Korea and China, ...
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Solvent-free method improves drug solubility using mesoporous silica
A large share of medicines developed today may never reach patients for a surprisingly simple reason: they cannot dissolve well enough in water. For most treatments, the oral route remains the gold ...
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