Search results for " stability"
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
If its level does not increase in the process or on stability testing, the occurrence score is low and its overall risk to the patient may be low. However, it is still rated as high risk due to its hi…
Article
Essentials in Establishing and Using Design Space
Variation due to stability may also be included as a noise factor.
Simulation, determination, and visualization of design margin
Using all sources of variation, simulation is used to…
Article
Elucidating Biosimilars Characterization
Characterization of the glycosylation present on recombinant proteins is particularly important as the glycans attached to the molecule can modulate the stability and ability of the molecule to elicit…
Article
Regulatory Challenges in the QbD Paradigm
The potential applications of quality risk management in quality systems, regulatory operations, development, facility and equipment design, material management, production, laboratory control, stabil…