This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when ...

Additionally, Content Uniformity (CU), which relies heavily on the proper blend uniformity of the final pharmaceutical product, must be verified for product release. During the development process, ...

Within the pharmaceutical industry, inline near infrared (NIR) spectroscopy is one of the most commonly applied process analytical technologies to monitor content uniformity of powder blends (1).

The Process Analytical Technology (PAT) initiative of the FDA helps pharmaceutical companies to improve the production process and consistently deliver products of better quality. For this purpose, it ...

ARLINGTON, Va. – The Product Quality Research Institute (PQRI) forwarded its first recommendation to the Food and Drug Administration (FDA) for review. The recommendation proposes that in-process ...