This concept paper supports a proposal for a new harmonized ICH guideline on important aspects for the qualification of PG biomarkers. Full document...

Bluetongue (BT) is a non-contagious, insect-transmitted disease that is caused by BT virus (BTV). It is principally a disease of sheep and other domestic and wild ruminant species. Full document...

Directive 2001/82/EC, as amended by Directive 2004/28/EC [1], includes new provisions regarding the consideration of effects on the environment in the benefit/risk assessment of veterinary medicinal products and on the data requirements regarding such effects. Full document...

Adjuvants are excipients used in immunological products due to their capacity to increase and/or prolong the immune response to the active ingredient. This activity is a matter separate from their potential pharmacological activity. Full document...

This paper addressed reflections on some aspects surrounding pre-analytical, analytical and postanalytical steps surrounding PGx samples, testing and data handling, key for the scientific reliability of PGx data submitted for regulatory evaluation. Full document...

This reflection paper focuses on coumarin-derivatives present in Angelica archangelica L., as these substances are the most relevant constituents for phototoxicity. In addition to these constituents, there are a large number of other compounds, which have been found e.g. in the essential oil. The safety of these constituents is not addressed in this paper. Full document...