May 15th 2025
Six winners and two honorable mentions were revealed at ISPE’s Europe Annual Conference in London.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3
May 2nd 2018The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
An Integrated Approach to Shipping Liquid in Single-Use Systems
May 2nd 2018Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
Proteus is Extending the Reach of the Digital Pill
April 26th 2018Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.