2023 Pharma Digital Transformation

At Natoli Scientific, we’re in the lab every day compiling thorough USP Tablet Compression Characterization data to help you identify and solve compaction problems and provide solutions.

An introduction to study designs for investigating the role of genes in disease will be provided, followed by an overview of statistical methods used to test hypotheses for each design. Examples of several designs will be discussed, as well as accompanying methods. Publications assessing the role of genetic variation in disease will be examined, and a critical critique of methods and results for each publication will be reviewed.

N-Nitrosamine impurity findings in marketed formulations of rifampin have disrupted drug development. As a strong cytochrome P450 3A4 (CYP3A4) inducer, rifampin was regularly co-administered with investigational products

Manufacturing has been paid dividends for many years through the use of quality tools such as statistical process control, quality function deployment, vendor audit management, hazard analysis critical control points (HACCP), value stream analysis, and other valuation methods. In the highly regulated industries that manufacture pharmaceuticals, foods, and cosmetics, the quality control ‘scientists’ have been typically known to perform sampling and testing for determining the acceptability of finished products. During the past decade, the pharmaceutical industry has seen a significant regulator-industry aligned paradigm change and an important leap into the formality of quality improvement using quality tools. The paradigm of final product testing (and the myth of ‘testing quality into products’) has been challenged by both the industry and regulators. Recent industry and regulatory support of ‘risk-based’ concepts and principles are intended to produce a ‘desired state’ of industry development and production of pharmaceuticals that have a higher level of consistency in meeting purity, safety, and efficacy than in prior history.