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dc.creatorOchoa-de-Olza, M. (María)-
dc.creatorOliva, M. (M.)-
dc.creatorHierro, C. (C.)-
dc.creatorMatos, I. (Ignacio)-
dc.creatorGarralda, E. (E.)-
dc.date.accessioned2024-02-09T07:58:58Z-
dc.date.available2024-02-09T07:58:58Z-
dc.date.issued2018-
dc.identifier.citationOchoa-de-Olza, M. (María); Oliva, M. (M.); Hierro, C. (C.); et al. "Early-drug development in the era of immuno-oncology: are we ready to face the challenges?". Annals of Oncology. 29 (8), 2018, 1727 - 1740es
dc.identifier.issn0923-7534-
dc.identifier.urihttps://hdl.handle.net/10171/68942-
dc.description.abstractThe classical development of drugs has progressively faded away, and we are currently in an era of seamless drug-development, where first-in-human trials include unusually big expansion cohorts in the search for early signs of activity and rapid regulatory approval. The fierce competition between different pharmaceutical companies and the hype for immune combinations obliges us to question the current way in which we are evaluating these drugs. In this review, we discuss critical issues and caveats in immunotherapy development. A particular emphasis is put on the limitations of pre-clinical toxicology studies, where both murine models and cynomolgus monkeys have underpredicted toxicity in humans. Moreover, relevant issues surrounding dose determination during phase I trials, such as dose–escalation methods or flat versus body-weight dosing, are discussed. A proposal of how to face these different challenges is offered, in order to achieve maximum efficacy with minimum toxicity for our patients.es_ES
dc.language.isoenges_ES
dc.publisherElsevieres_ES
dc.rightsinfo:eu-repo/semantics/closedAccesses_ES
dc.subjectImmunotherapyes_ES
dc.subjectEarly-drug developmentes_ES
dc.subjectToxicology studieses_ES
dc.subjectDose determinationes_ES
dc.titleEarly-drug development in the era of immuno-oncology: are we ready to face the challenges?es_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.identifier.doi10.1093/annonc/mdy225-
dadun.citation.endingPage1740es_ES
dadun.citation.number8es_ES
dadun.citation.publicationNameAnnals of Oncologyes_ES
dadun.citation.startingPage1727es_ES
dadun.citation.volume29es_ES

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