ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...

The main market opportunity lies in offering advanced stability testing training that aligns with the latest regulatory guidelines. This is crucial as products grow complex and supply chains extend ...

Comprehensive guide on ICH Q1A(R2) storage conditions, testing intervals, stability data for IND/NDA submission, and designing FDA-compliant stability programs ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

PITTSBURGH — The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug substances and drug products is an attempt to revise the current ICH Q1 guideline, ...

Biologics stability testing in pharmaceutical R&D typically requires weeks of waiting between processes. Formulation scientists must develop, assess, and then wait to discover if a formulation remains ...

Many months after Phathom Pharmaceuticals won FDA approval for vonoprazan as part of two combinations to treat Helicobacter pylori infection, the drugmaker is still unable to launch the product. Back ...

insights from industryYoann LefeuvreDirector of Product ManagementMicrotrac In this interview, AZoNano speaks with Yoann Lefeuvre, Director of Product Management at Microtrac. Yoann discusses ...