The FDA's expanding embrace of new approach methodologies (NAMs) is forcing pharmaceutical manufacturing and quality teams to rethink how preclinical and CMC data will be generated, validated, and ...

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating ...

Medication nonadherence remains one of the widest gaps between how a drug performs in clinical trials and how it performs in ...

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 ...

The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral ...

PharmTech covered one of the industry’s biggest events this week, as CPHI Milan was in full force with experts arguing that ...

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

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 ...

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

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

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

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 ...