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Drug Metabolism and Personalized Therapy

Official journal of the European Society of Pharmacogenomics and Personalised Therapy

Editor-in-Chief: Llerena, Adrián

Editorial Board: Benjeddou, Mongi / Chen, Bing / Dahl, Marja-Liisa / Devinsky, Ferdinand / Hirata, Rosario / Hubacek, Jaroslav A. / Ingelman-Sundberg, Magnus / Maitland-van der Zee, Anke-Hilse / Manolopoulos, Vangelis G. / Marc, Janja / Melichar, Bohuslav / Meyer, Urs A. / Nair, Sujit / Nofziger, Charity / Peiro, Ana / Sadee, Wolfgang / Salazar, Luis A. / Simmaco, Maurizio / Turpeinen, Miia / Schaik, Ron / Shin, Jae-Gook / Visvikis-Siest, Sophie / Zanger, Ulrich M.

CiteScore 2018: 1.01

SCImago Journal Rank (SJR) 2018: 0.277
Source Normalized Impact per Paper (SNIP) 2018: 0.446

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Volume 34, Issue 2


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

Luana Mifsud Buhagiar
  • Corresponding author
  • Medicines Authority, Malta Life Sciences Park, San Ġwann, Malta
  • Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Benjamin Micallef / John Joseph Borg / Helen Vella / Anthony Serracino Inglott
  • Medicines Authority, Malta Life Sciences Park, San Ġwann, Malta
  • Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Godfrey LaFerla
Published Online: 2019-05-30 | DOI: https://doi.org/10.1515/dmpt-2019-0005


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.

Keywords: established drugs; labeling; pharmacogenetics; regulatory; vigilance


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About the article

Received: 2019-02-03

Accepted: 2019-02-11

Published Online: 2019-05-30

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: Research funded by the ENDEAVOUR Scholarships scheme.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Citation Information: Drug Metabolism and Personalized Therapy, Volume 34, Issue 2, 20190005, ISSN (Online) 2363-8915, DOI: https://doi.org/10.1515/dmpt-2019-0005.

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