Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed.

Amiloride-sensitive fluid resorption in NCI-H441 lung epithelia depends on an apical Cl(-) conductance.

Proper apical airway surface hydration is essential to maintain lung function. This hydration depends on well-balanced water resorption and secretion. The mechanisms involved in resorption are still a matter of debate, especially as the measurement of transepithelial water transport remains challenging.

Novartis School Lab: bringing young people closer to the world of research and discovering the excitement of science.

The Novartis School Lab (http://www.novartis.ch/schullabor) is an institution with an old tradition.

Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker.

Purpose: The detection of safety signals with medicines is an essential activity to protect public health. Despite widespread acceptance, it is unclear whether recently applied statistical algorithms provide enhanced performance characteristics when compared with traditional systems. Novartis has adopted a novel system for automated signal detection on the basis of disproportionality methods within a safety data mining application (Empirica™ Signal System [ESS]).