Reference-scaled Average Bioequivalence Blog Post

The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an approved (ie, reference) drug in their...

Can QSP Save Lives? Lessons from the Bial Trial Debacle Blog Post

One of the biggest challenges for the pharmaceutical industry is the high rate of drug attrition in Phase 2 clinical trials, which wastes significant amounts of money and time. The major reasons for this attrition are that either candidate drugs do not show efficacy or have unexpected toxicity, in turn implying that we did not fully understand the complexity of the biology the candidate drugs were designed to modulate.

Cardiac Safety Simulator Blog Post

薬物誘発性心血管リスクを早期に予測し、情報に基づいた適切な判断により、高額な後期段階での失敗を減少させます。