In order to achieve the desired properties in a solid medicinal product, a granulate must be optimally prepared. Did you know that you can have a significant influence on the material properties of your granulate using different granulation techniques? The wet granulation of pharmaceutical granulate mixtures with subsequent fluidized bed drying represents the most important step in the manufacture of solids. But there are other techniques, too. You can find out here which other processes you should know about.
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.