Targeting Complement to Reduce Disease Activity: Challenges and Opportunities in the Publicly Available Data (Part Two)

Targeting Complement to Reduce Disease Activity: Challenges and Opportunities in the Publicly Available Data (Part Two)

Authors: Shoda L, Kenz Z, Clemens L

In part one of this complement blog series, the complement cascade and its role in various diseases was introduced, as well as the potential for mechanistic modeling to support development of complement‑targeted therapeutics. COMPLEMENTsym, a quantitative systems pharmacology (QSP) model of complement focused on the alternative and terminal pathways (AP, TP, respectively) was introduced.

Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies

Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies

Authors: Garcia-Arieta A

One of the significant challenges faced by pharmaceutical companies is the sometimes unclear guidance on what data regulators want to see included in their submissions and the format in which it should be provided.