Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use ...

Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere. Richard Jaenisch and Chris Cole dig into whether New Approach ...

Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs ...

As publishers and research platforms such as Reaxys and Springer Nature build application programming interface (API) access ...

Access Part 1 of this interview in which Scarboro explains why real-world usability belongs at product definition. Access ...

Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, ...

The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a ...

Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied ...

The FDA has approved remibrutinib for symptomatic dermographism, the first such therapy, extending an oral BTK inhibitor ...

Shadow AI and vendor data retention put GMP records and trade secrets at risk. AI Pulse Check panelists outline what pharma ...

Companies showcasing equipment and services at the event include Shilpa Biologicals (Booth 12J33), which is announcing the ...

In US regulatory news, the FDA opened applications for its Expedited IND Pilot on September 15. 1 The program pairs drug ...