Pharmaceutical product discontinuations unrelated to safety

Pharmaceutical Product Liability

Product liability is one of the fastest growing and most economically significant applications of tort law. Product liability actions against pharmaceutical companies are among the most widely publicized classes of suits in the United States and Europe, prompting pharmaceutical companies to lobby vigorously for tort reform. (Nace et al., 1997). The liability burden on pharmaceutical companies h...

Automating Pharmaceutical Safety Surveillance process

Pharmaceutical companies invest huge amount of effort and cost in launching a drug into the market, keeping the two aspects in mind i.e. safety and efficacy. Post launching the drugs into the market, the organisations then need to monitor the adverse events from these drugs, and need to take the action accordingly. In this white paper few approaches are discussed for automating the post market ...

The safety of pharmaceutical excipients.

The most important part of a medicine as far as its weight is concerned, is constituted by its excipients, which have the important functions of guaranteeing the dosage, stability and bioavailability of the active principle. The components employed as excipients must present the characteristics required by their technological function but, as with any substance administered to man, they must al...

Advances in Aseptic Blow-Fill-Seal Processing of Pharmaceutical Liquids Improve Product Integrity and Patient Safety

A Bayesian Approach to Pharmaceutical Product Quality Risk Quantification

The FDA’s Quality by Design initiative and associated design space construct (ICH, 2009), have stimulated the use of quantitative methods, mathematical and statistical models, and designed experiments in the process of drug development and manufacture. For a given drug product, the design space may be interpreted as the constrained region of the manufacturing operating variable space within whi...