BD’s new Intevia 1mL two-step disposable autoinjector, a device that combines an autoinjector and a pre-fillable syringe into one system, has a two-step, push-on-skin activation feature that allows the effective and safe injection of drugs of different viscosities up to 35cP and different fill volumes up to 1mL.
Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.