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 ...

Shadow AI and vendor data retention put GMP records and trade secrets at risk. AI Pulse Check panelists outline what pharma AI policies require. PharmTech AI Pulse Check episode 2 covers AI data ...

The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.

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 ...

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

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

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, explains the demand for spray drying and the hurdles involved with scale up, ...