Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.
This webinar offers information on metrological traceability, the hierarchy of reference materials, certificates of analysis, reference material formats and uses, and fit-for-purpose selection considerations.
It is essential to generate robust data that demonstrates the maintenance of seal integrity during deep cold storage and/or transport which, in turn, requires a robust container closure integrity test method.