Regulatory sciences and translational pharmacogenetics: amitriptyline as a case in point

Regulatory developments and clinical implementation, or the lack thereof, are primary clinchers, in the enduring endeavors to realize the translational quality of pharmacogenetics. Here, we present the case of amitriptyline, an established drug with pharmacogenetic implications. The integration of p...

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Bibliographic Details
Published inDrug metabolism and personalized therapy Vol. 34; no. 2
Main Authors Mifsud Buhagiar, Luana, Micallef, Benjamin, Borg, John Joseph, Vella, Helen, Serracino Inglott, Anthony, LaFerla, Godfrey
Format Journal Article
LanguageEnglish
Published Germany 30.05.2019
Subjects
Amitriptyline - metabolism
Government Regulation
Humans
Pharmacogenetics
Translational Medical Research
established drugs
vigilance
labeling
regulatory
pharmacogenetics
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Summary:Regulatory developments and clinical implementation, or the lack thereof, are primary clinchers, in the enduring endeavors to realize the translational quality of pharmacogenetics. Here, we present the case of amitriptyline, an established drug with pharmacogenetic implications. The integration of pharmacogenetic information in the official product literature and throughout the evaluation of safety concerns is considered. In our opinion, apart from emboldening genomic research in drug development and the valid pursuit towards global harmonization in the field, it is rational to look into the applicability of the data we have today.
ISSN:2363-8915