The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline ...

Pharmaceutical companies in the US are requesting additional information on how to conduct stability testing for both new and existing drugs in response to the International Council for ...

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.

Experts have hailed the proposed draft Schedule M guidelines placing significant emphasis on stability testing compared to the existing Schedule M. This marks a commendable stride in aligning with ...