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

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The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture ...

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

Maximizing and validating the stability of a drug is critical throughout its life cycle, beginning in the development phase of an active pharmaceutical ingredient (API), continuing through the final ...

European Union has issued guidelines on stability testing for application in order to support a variation to a Marketing Authorization. The guideline provides general guidance on stability testing.

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 ...