Ruxolitinib
Ruxolitinib idiki molecule Janus kinase inhibitor iyo inoshandiswa mukurapa kwepakati kana yakanyanya njodzi myelofibrosis uye inodzivirira mafomu e polycythemia vera uye graft-vs-host chirwere.Ruxolitinib inosanganiswa nekukwira kwenguva pfupi uye kazhinji kunyoro mu serum aminotransferase panguva yekurapa uye kune zvisingawanzo zviitiko zvekuzvimiririra, zvinoratidzika sekiriniki idiosyncratic acute chiropa kukuvara pamwe chete nezviitiko zvekugadzirisazve hepatitis B muvanhu vanobatwa.
Ruxolitinib is an orally bioavailable Janus-associated kinase (JAK) inhibitor ine zvinogona antineoplastic uye immunomodulating zviitiko.Ruxolitinib inonyanya kusunga uye inhibits proteintyrosinekinases JAK 1 uye 2, iyo inogona kutungamirira kukudzikisira kwekuputika uye kudziviswa kwekuwedzera kwemasero.Iyo JAK-STAT (signal transducer uye activator of transcription) nzira inoita basa rinokosha pakuratidza ma cytokines akawanda uye kukura kwezvinhu uye inobatanidzwa mukupararira kwemasero, kukura, hematopoiesis, uye maitiro ekudzivirira zvirwere;JAK kinases inogona kukwidziridzwa muzvirwere zvinoputika, myeloproliferative disorders, uye zvirwere zvakasiyana-siyana.
Ruxolitinib is apyrazoleinotsiviwa panzvimbo 1 neboka re2-cyano-1-cyclopentylethyl uye panzvimbo 3 neboka repyrrolo [2,3-d] pyrimidin-4-yl.Inoshandiswa semunyu wephosphate pakurapa varwere vane myelofibrosis yepakati kana yepamusoro, kusanganisira primary myelofibrosis, post-polycythemia vera myelofibrosis uye post-essential thrombocythemia myelofibrosis.Iine basa seantineoplastic agent uye EC 2.7.10.2 (isina-specific protein-tyrosinekinase) inhibitor.Ndiyo nitrile, apyrrolopyrimidineuye nhengo yepyrazoles.
Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.
Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.
Kutariswa kwemhando yepamusoro kunofamba kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando nekurapa.
Professional Regulatory Affairs timu inotsigira zvinodiwa zvemhando panguva yekushandisa uye kunyoreswa.