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The EMA glossary defines a biological marker, or biomarker, as ‘an objective and quantifiable measure of a physiological process, pathological process or response to a treatment (excluding measurements of how an individual feels or functions)’. Similarly, the FDA defines a biomarker as ‘a defined characteristic that is measured as an indicator of normal biological processes, continue reading…
Drug development is a daunting and difficult task where all the puzzle pieces need to click to result in an efficacious and safe treatment for patients. It is a high-risk endeavor involving many different scientific and non-scientific disciplines over a long period of time. The current estimates to develop a drug are about 2.3 continue reading…
The Göttingen Minipig was developed at the University in Göttingen, Germany to meet the demand for a non-rodent model with many similarities to humans as genetic management is required to minimise inbreeding and drift and to maintain the genetic integrity of the population. The genetics for the entire breeding population is still managed in Göttingen continue reading…
The 4 pivotal questions you have on PDEs answered: A shared concern on how to create science-based PDEs. From a safety perspective, all companies with multifunctional pharmaceutical and chemical production facilities must be able to adequately determine cleaning limits and permitted daily exposures (PDEs) by characterizing the effects of possible cross-contamination in the non-intended patient continue reading…
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