A0487
Title: K-cover: A novel way to compare distributions in the context of drug development
Authors: Gerhard Goessler - University of Graz (Austria) [presenting]
Vera Hofer - University of Graz (Austria)
Hans Manner - University of Graz (Austria)
Walter Goessler - University of Graz (Austria)
Abstract: One of the hurdles in the development of generic drugs is frequently the statistical demonstration of the similarity of the test product (generic) to a reference medicinal product (originator) concerning several quality attributes (QAs). It raises the question of how to describe similarity in a suitable mathematical way. A mathematical concept is proposed for comparing the QA distributions that take account of the asymmetrical nature of the problem, i.e. the distribution of the QA of the test product has to be suitably covered by that of the reference product. For the QA distribution of the test product, this approach allows the central fraction of the probability mass to vary within certain limits derived from the QA distribution of the reference product while simultaneously demanding strict restrictions on the more extreme parts, i.e., the tails, of the test product distribution. It allows for the account of consumer safety in situations where no information is available on specified values and tolerances.
