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dc.creatorGutierrez, Lucas
dc.creatorCauchon, Nina S.
dc.creatorChristian, Twinkle R.
dc.creatorGiffin, Mike
dc.creatorAbernathy, Michael J.
dc.date.accessioned2020-09-25T15:36:02Z
dc.date.available2020-09-25T15:36:02Z
dc.date.created2020
dc.identifier.issn0022-3549spa
dc.identifier.otherhttps://doi.org/10.1016/j.xphs.2020.09.025spa
dc.identifier.urihttp://hdl.handle.net/20.500.12010/13793
dc.description.abstractThe field of human therapeutics has expanded tremendously from small molecules to complex biological modalities, and this trend has accelerated in the last two decades with a greater diversity in the types and applications of novel modalities, accompanied by increasing sophistication in drug delivery technology. These innovations have led to a corresponding increase in the number of therapies seeking regulatory approval, and as the industry continues to evolve regulations will need to adapt to the everchanging landscape. The growth in this field thus represents a challenge for regulatory authorities as well as for sponsors. This review provides a brief description of novel biologics, including innovative antibody therapeutics, genetic modification technologies, new developments in vaccines, and multifunctional modalities. It also describes a few pertinent drug delivery mechanisms such as nanoparticles, liposomes, coformulation, recombinant human hyaluronidase for subcutaneous delivery, pulmonary delivery, and 3D printing. In addition, it provides an overview of the current CMC regulatory challenges and discusses potential methods of accelerating regulatory mechanisms for more efficient approvals. Finally, we look at the future of biotherapeutics and emphasize the need to bring these modalities to the forefront of patient care from a global perspective as effectively as possible.spa
dc.format.extent33 páginasspa
dc.format.mimetypeapplication/pdfspa
dc.language.isoengspa
dc.publisherJournal of Pharmaceutical Sciencesspa
dc.sourcereponame:Expeditio Repositorio Institucional UJTLspa
dc.sourceinstname:Universidad de Bogotá Jorge Tadeo Lozanospa
dc.subjectAntibody Drug(s)spa
dc.subjectAutomationspa
dc.subjectDrug Designspa
dc.subjectGene Therapyspa
dc.subjectImmunotherapyspa
dc.subjectLiposomespa
dc.subjectNanoparticle(s)spa
dc.subjectRegulatory Sciencespa
dc.subjectTargeted Drug Deliveryspa
dc.subjectVaccinesspa
dc.titleThe confluence of innovation in therapeutics and regulation: recent cmc considerationsspa
dc.type.localArtículospa
dc.subject.lembSíndrome respiratorio agudo gravespa
dc.subject.lembCOVID-19spa
dc.subject.lembSARS-CoV-2spa
dc.subject.lembCoronavirusspa
dc.rights.accessrightsinfo:eu-repo/semantics/openAccessspa
dc.type.hasversioninfo:eu-repo/semantics/acceptedVersionspa
dc.rights.localAbierto (Texto Completo)spa
dc.identifier.doihttps://doi.org/10.1016/j.xphs.2020.09.025spa
dc.type.coarhttp://purl.org/coar/resource_type/c_2df8fbb1spa


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