Drug Safety
Methodds assembles experts in drug safety with the combined medical and pharmacological experience from drug regulation and research, as well as data science expertise, with development of innovative statistical and machine learning methodologies applied to drug safety.
Methodds can support you with any type of drug safety issue. We are specialized in qualitative and quantitative expert advice, with a special strength on the use of Real World Data such as pharmacovigilance databases, electronic health records, or hospital data in order to generate new evidence.
Given our long-standing experience within the European and Swiss drug regulators we can support organizations with medicinal products and pharmaceuticals and provide relevant insights and advice. Additionally, we also facilitate pre-emptive analyses in order to detect and classify safety signals.
Case example
Acute Generalized Exanthematous Pustulosis (AGEP) is a rare adverse drug reaction typically associated to antibiotics which affects less than five cases per million per year. Given the low number of cases yearly, it has been difficult to establish associations of drug combinations with the onset of AGEP.
Therefore, we used an innovative network analysis approach in VigiBase, the WHO pharmacovigilance database, in order to detect drug combinations associated to AGEP. Thanks to this approach we were able to generate a new hypothesis about this rare adverse drug reaction: cardiovascular drugs, or underlying cardiovascular diseases, might be associated with AGEP onset.
Published in:
Martinez-De la Torre A, van Weenen E, Kraus M, Weiler S, Feuerriegel S, Burden AM. A Network Analysis of Drug Combinations Associated with Acute Generalized Exanthematous Pustulosis (AGEP). Journal of Clinical Medicine. 2021; 10(19):4486. https://doi.org/10.3390/jcm10194486
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