Do you face challenges when it comes to the particle quality in your granulation process? In order to produce granules with the desired properties, scale-up is crucial, in addition to looking at the process parameters. After all, the path of a drug from the laboratory to production holds many a surprise. Especially in the case of particles for inhalers, the mixing process plays a decisive role.
Learn what you need to consider to produce the perfect particle. This whitepaper reveals expert know-how on the mixing details, the key figures to consider and the positive effects using the practical example of inhalants.
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.