Discover how advanced detectors are driving improvements in biopharma quality assurance by enhancing precision across ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

Abstract: The Tweedie exponential dispersion (TED) process provides a flexible framework for degradation process modeling. To obtain degradation information quickly and realistically, we focus on the ...

Abstract: One-shot devices, such as automotive airbags, fire extinguishers and ammunitions, pose significant challenges in their reliability analysis due to their inherently unobservable lifespans.

With the first half of this discussion in BPI’s October 2025 issue, I introduced the basics of phased stability testing, a fundamental component of ensuring biopharmaceutical quality, safety, and ...