Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies. Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March ...

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development. The stability of clinical trial materials, regardless of the trial ...

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 ...

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

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, ...