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The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing(More)
The evaluation of quality, safety and efficacy of medicinal products by regulatory agencies is a necessary step for obtaining marketing authorisation in the European Union (EU). The objective of this paper is to outline some key aspects of the EU regulatory system relevant to the field of oncology. Regulatory standards in oncology and the experience with(More)
Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to(More)
Pharmacogenetics, one of the cornerstones of personalized medicine, has the potential to change the way in which health care is offered by stratifying patients into various pretreatment categories, such as likely responders, likely non-responders or likely to experience adverse drug reactions. In order to advance drug development and regulatory science,(More)
Unmet medical needs are a priority for organizations such as the WHO and major public-private initiatives, such as Innovative Medicines Initiative, were established to speed up the development of better and safer medicines for patients. To assist such projects, the EMA in its 'Road Map to 2015' considered the mapping of unmet medical needs as a priority.(More)
STAT6 links IL-4/IL-13 stimulation with pendrin expression in asthma and chronic obstructive pulmonary disease. The molecular and functional interaction between ICLN and HSPC038 modulates the regulation of cell volume. channel blockers reverse iron overload by a new mechanism via divalent metal transporter-1.
This article provides an overview of the European Union (EU) framework for the marketing authorisation of medicinal products, at both European and National level, and aims to demonstrate the current position and experience with nanomedicines. It will be described how the EU promotes the development of new nanomedicines by publishing guidance, providing(More)