In their article, How Courts Adjudicate Patent Definiteness and Disclosure, John R. Allison and Lisa Larrimore Ouellette present a comprehensive study—thirty years’ worth of cases—of federal courts’ application of patent law’s written-description, definiteness, and enablement requirements. Using their own hand-coded dataset, Allison and Ouellette measure a number of interesting disparities in c...

Process Analytical Technology (PAT) has been introduced as an advent of new tool which has given an opportunity for all the pharmaceutical manufacturers to improve upon their quality and compliance. The application of this technology in pharmaceutical manufacturing ensures the quality of raw material attributes that too at-line, in-line or online, which was difficult earlier, thereby decreasing...

This presented paper deals with application of three multivariate calibration methods methods for simultaneous spectrophotometric determination of two active substances in combined pharmaceutical formulation, composed of rutin (RU) and ascorbic acid (AA). The multivariate methods are classical least squares (CLS), principal component regression (PCR) and partial least squares (PLS). The results...

Pharmaceutical drugs play an important role in human life since they caused a revolution in human health. Notably, their administration to a living organism helps body to stay healthy. Commonly, they are employed to diagnose, prevent, or treat and cure a disease via a biological effect on a human body. Administration of impurity-free and adequate amounts of pharmaceut...

A real-time THz color scanner has the potential to further expand the application scope of THz spectral imaging based on its rapid image acquisition rate. We demonstrated three possible applications of a THz color scanner in the biomedical field: imaging of pharmaceutical tablets, human teeth, and human hair. The first application showed the scanner's potential in total inspection for rapid qua...

pray-dried (SD) lactose was introduced to the pharmaceutical market in the 1960s as an excipient that enables direct compression of formulations in a simple manufacturing process (1). To this day, lactose remains one of the most popular excipients for active pharmaceutical ingredients (APIs) whose dose makes them suitable for direct compression. Several manufacturers make and sell SD lactose, a...

We describe the emerging issues related to warnings with respect to pharmaceutical company use of the internet as a vehicle for direct-to-consumer marketing (DTC) and market research. We describe the various techniques pharmaceutical companies have used to exploit this new communications medium which permits two way exchange of information. The Food and Drug Administration (FDA) has not issued ...

Pharmaceutical companies spend billions of dollars annually on drug discovery research. In the process, they generate vast amounts of scientific data. Data warehousing could significantly shorten the research cycle that leads to a new drug. We propose a framework for the application of data warehousing to integrate a pharmaceutical company’s drug discovery data. We provide an analysis of the pr...

QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining a target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability and controlling...

In the pharmaceutical industry, computational methods have gained a major role in the discovery and development of new drugs. Yet, synthesis of the pharmaceutical compounds is among the most crucial steps of drug design along with the life science discoveries complementing it. The review focuses on all the recent developments in the application of computational methods as well as organic synthe...