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 ...

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, ...

Such testing is essential to ensure that the drug product maintains the desired efficacy and purity after transportation and storage. Various constituents of the pharmaceutical product, including the ...

While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the ...

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

The US Food and Drug Administration (FDA) has warned Baesweiler, Germany-based contract manufacturer BBT Biotech GMBH over deviations from good manufacturing practices (GMPs), including the failure to ...