If you’re in the business of pharmaceutical product development or manufacturing for the US market, this brief talk by Dr. Richard Sidwell is for you. The need for pharmaceutical products is higher than ever. At the same time, the ability to develop and supply new products is being constrained by demographics, geopolitics, energy, and inflation. This is why it’s more important than ever to strategically invest in CMC development and engineering, onshoring, and thoughtful supply chain design. Dr. Sidwell discusses recent trends in drug product development and manufacturing given the current demographic, geopolitical, and macroeconomic trends.
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
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 simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Susan J. 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 with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.