Concerns about pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) studies in the new therapeutic area of COVID-19 infection

dc.creatorVenisse, Nicolas
dc.creatorPeytavin, Gilles
dc.creatorBouchet, Stephane
dc.creatorGagnieu, Marie Claude
dc.creatorGarraffo, Rodolphe
dc.creatorGuilhaumou, Romain
dc.creatorSolas, Caroline
dc.date.accessioned2020-08-31T17:27:31Z
dc.date.available2020-08-31T17:27:31Z
dc.date.created2020-09
dc.description.abstractenglishIn the context of the COVID-19 pandemic, several drugs have been repurposed as potential candidates for the treatment of COVID-19 infection. While preliminary choices were essentially based on in vitro potency, clinical translation into effective therapies may be challenging due to unfavorable in vivo pharmacokinetic properties at the doses chosen for this new indication of COVID-19 infection. However, available pharmacokinetic and pharmacokinetic-pharmacodynamic studies suffer from severe limitations leading to unreliable conclusions, especially in term of dosing optimization. In this paper we propose to highlight these limitations and to identify some of the major requirements that need to be addressed in designing PK and PK-PD studies in this era of COVID. A special attention should be paid to pre-analytical and analytical requirements and to the proper collection of covariates affecting dose-exposure relationships (co-medications, use of specific organ support techniques and other clinical and para-clinical data). We also promote the development of population PK and PK-PD models specifically dedicated to COVID-19 patients since those previously developed for other diseases (SEL, malaria, HIV) and clinical situations (steady-state, non-ICU patients) are not representative of severe patients. Therefore, implementation of well-designed PK and PD studies targeted to COVID-19 patients is urgently needed. For that purpose we call for multi-institutional collaborative work and involvement of clinical pharmacologists in multidisciplinary research consortia.spa
dc.format.extent9 páginasspa
dc.format.mimetypeapplication/pdfspa
dc.identifier.doihttps://doi.org/10.1016/j.antiviral.2020.104866spa
dc.identifier.issn0166-3542spa
dc.identifier.otherhttps://www.sciencedirect.com/science/article/pii/S0166354220302801?via%3Dihubspa
dc.identifier.urihttps://hdl.handle.net/20.500.12010/12477
dc.language.isoengspa
dc.publisherAntiviral Researchspa
dc.rights.accessrightsinfo:eu-repo/semantics/embargoedAccessspa
dc.rights.localAcceso restringidospa
dc.sourcereponame:Expeditio Repositorio Institucional UJTLspa
dc.sourceinstname:Universidad de Bogotá Jorge Tadeo Lozanospa
dc.subjectCOVID-19spa
dc.subject.keywordPharmacokineticsspa
dc.subject.keywordPharmacodynamicsspa
dc.subject.keywordPK-PDspa
dc.subject.lembSíndrome respiratorio agudo gravespa
dc.subject.lembCOVID-19spa
dc.subject.lembSARS-CoV-2spa
dc.subject.lembCoronavirusspa
dc.titleConcerns about pharmacokinetic (PK) and pharmacokinetic-pharmacodynamic (PK-PD) studies in the new therapeutic area of COVID-19 infectionspa
dc.type.coarhttp://purl.org/coar/resource_type/c_6501spa
dc.type.hasversioninfo:eu-repo/semantics/acceptedVersionspa
dc.type.localArtículospa

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