I-Bictegravir 1611493-60-7

Incazelo emfushane:

Igama le-API Inkomba Umsunguli Idethi yokuphelelwa yisikhathi kwelungelo lobunikazi(e-US)
I-Bictegravir 1611493-60-7 Ukutheleleka nge-HIV-1 Isayensi YaseGileyadi Disemba 19, 2033


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

IMINININGWANE YOMKHIQIZO

Incazelo

I-Bictegravir iyinoveli, inhibitor enamandla ye-HIV-1 integrase ene-IC50 engu-7.5 nM.

Ku-Vitro

I-Bictegravir (BIC) ivimbela umsebenzi wokudlulisa i-strand nge-IC50 ye-7.5± 0.3 nM.Ngokuphathelene nokuvinjwa kwayo komsebenzi wokudlulisa i-strand, i-Bictegravir iyi-inhibitor ebuthakathaka kakhudlwana yama-3.'-ukucubungula umsebenzi we-HIV-1 IN, nge-IC50 yama-241±51 nM.I-Bictegravir ithuthukisa ukunqwabelana kwendilinga engu-2-LTR ~ 5 ngokuphindwe ka-5 ngokuhlobene nokulawula okwenziwe mbumbulu futhi yehlisa inani lemikhiqizo eyiqiniso yokuhlanganisa kumaseli anegciwane ngokuphindwe kayikhulu.I-Bictegravir ivimbela ngokunamandla ukuphindaphinda kwe-HIV-1 kuwo womabili amaseli e-MT-2 kanye ne-MT-4 anama-EC50s we-1.5 kanye no-2.4 nM, ngokulandelana.I-Bictegravir ibonisa imiphumela enamandla yokulwa namagciwane kuwo womabili ama-lymphocyte e-CD4+ T ayinhloko kanye nama-macrophages atholakala ku-monocyte, nama-EC50s angu-1.5±0.3 nM kanye no-6.6±4.1 nM, ngokulandelanayo, aqathaniswa namanani atholwe emigqeni ye-T-cell[1].

I-MCE ayizange iqinisekise ngokuzimela ukunemba kwalezi zindlela.Ezethenjwa kuphela.

Inombolo ye-NCT Umxhasi Isimo Usuku okuqalwa ngalo

Isigaba

I-NCT03998176 Inyuvesi yaseNebraska|Gilead Sciences I-HIV-1-ukutheleleka Okthoba 9, 2019

Isigaba 4

I-NCT03789968 Thomas Jefferson University|University of Maryland, College Park|Indiana University Health|The Brooklyn Hospital Center|University of Illinois eChicago|Nova Southeastern University|University of California, San Francisco I-HIV+AIDS Septhemba 1, 2019
I-NCT04249037 Inyuvesi yaseColorado, eDenver|Gilead Sciences I-HIV+AIDS Mashi 1, 2020

Akufaneleki

I-NCT04132674 Isikhungo Sezifo Ezithathelwanayo saseVancouver I-Human Immunodeficiency Virus I Infection|Ukusetshenziswa Kwezidakamizwa Novemba 26, 2018

Isigaba 4

I-NCT04054089 Cristina Mussini|University of Modena kanye noReggio Emilia Ukutheleleka nge-HIV Septhemba 2019

Isigaba 4

I-NCT04155554 Azienda Ospedaliera Universitaria Senese|Catholic University of the Sacred Heart|Ospedale Policlinico San Martino|Azienda Ospedaliera San Paolo|Ospedale Amedeo di Savoia I-HIV-1-ukutheleleka Januwari 29, 2020

Isigaba 3

I-NCT02275065 Isayensi YaseGileyadi I-HIV-1 Ukutheleleka Okthoba 2014

Isigaba 1

I-NCT03711253 Inyuvesi yaseSouthern California Ukutheleleka nge-HIV Acute Okthoba 14, 2019

Isigaba 4

I-NCT02400307 Isayensi YaseGileyadi I-HIV Ephreli 17, 2015

Isigaba 1

I-NCT03499483 I-Fenway Community Health Ukuvimbela I-HIV Januwari 24, 2019

Isigaba 4

I-NCT03502005 Midland Research Group, Inc.|Gilead Sciences I-Human Immunodeficiency Virus Mashi 1, 2018

Isigaba 4

Isakhiwo samakhemikhali

Bictegravir-1611493-60-7

ISItifiketi

2018 GMP-2
原料药GMP证书201811(captopril ,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

UKUPHATHWA KWEKHWALITHI

Quality management1

Isiphakamiso18Amaphrojekthi Wokuhlola Ukuvumelana Kwekhwalithi asegunyaziwe4, futhi6amaphrojekthi angaphansi kokugunyazwa.

Quality management2

Uhlelo lokuphatha ikhwalithi yamazwe ngamazwe oluthuthukile lwenze isisekelo esiqinile sokuthengisa.

Quality management3

Ukugadwa kwekhwalithi kusebenza kuwo wonke umjikelezo wempilo womkhiqizo ukuze kuqinisekiswe ikhwalithi nomphumela wokwelapha.

Quality management4

Ithimba Lezindaba Zokulawula Ochwepheshe lisekela izimfuno zekhwalithi ngesikhathi sokufaka isicelo nokubhaliswa.

UKUPHATHWA KOMKHIQIZO

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I-Korea Countec Bottled Packaging Line

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I-Italy CAM Board Packaging Line

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Umshini Wokuhlanganisa we-Fette waseJalimane

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I-Japan Viswill Tablet Detector

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UZAkwethu

Ukubambisana kwamazwe ngamazwe
International cooperation
Ukubambisana kwasekhaya
Domestic cooperation

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