Latest Articles

  • The Human Advantage in ADME Testing

    Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more

  • Horizon Lines: A Quarterly Review of NDAs – April to June 2026

    This quarterly review on New Drug Applications contains data for applications approved for the first time during the second quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. read more

  • An Interview with Rod Ketner, PhD

    Sponsors sometimes optimize too narrowly for the next milestone instead of the full development path. A formulation may be sufficient for an early study but still be poorly positioned for robust scale-up, transfer, or validation. That’s where delays and added costs show up. read more

  • AI Technologies in Pharmacovigilance

    Leading pharmaceutical companies are predominantly applying AI to case intake and early case processing in PV, where rising Individual Case Safety Reports (ICSRs) volumes and diverse report formats have made manual handling increasingly unsustainable. AI is used to support data intake, extraction, and transformation up to the point where information can be integrated into the safety database, while downstream steps like case assessment and medical review largely remain human-led. read more