Bictegravir 1611493-60-7

Kufotokozera Kwachidule:

Dzina la API Chizindikiro Woyambitsa Tsiku Lomaliza Ntchito (The US)
Bictegravir 1611493-60-7 HIV-1 matenda Sayansi ya Gileadi Dec. 19, 2033


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

PRODUCT DETAIL

Kufotokozera

Bictegravir ndi novel, inhibitor yamphamvu ya HIV-1 integrase yokhala ndi IC50 ya 7.5 nM.

Mu Vitro

Bictegravir (BIC) imalepheretsa kusintha kwa chingwe ndi IC50 ya 7.5± 0.3 nm.Mogwirizana ndi kuletsa kwake kusuntha kwa strand, Bictegravir ndi inhibitor yofooka kwambiri ya 3.''-kukonza ntchito ya HIV-1 IN, yokhala ndi IC50 ya 241±51 nm.Bictegravir imapangitsa kudzikundikira kwa 2-LTR mabwalo ~ 5-fold pokhudzana ndi kuwongolera konyozedwa ndikuchepetsa kuchuluka kwa zophatikizika zenizeni m'maselo omwe ali ndi kachilombo ndi 100-fold.Bictegravir imalepheretsa kubwereza kwa HIV-1 m'maselo onse a MT-2 ndi MT-4 okhala ndi ma EC50 a 1.5 ndi 2.4 nM, motsatana.Bictegravir imasonyeza mphamvu zowononga tizilombo toyambitsa matenda m'ma CD4+ T lymphocytes ndi macrophages opangidwa ndi monocyte, ndi EC50s ya 1.5±0.3 nM ndi 6.6±4.1 nM, motsatira, zomwe zimafanana ndi zomwe zimapezeka mu T-cell mizere[1].

MCE sinatsimikizire paokha kulondola kwa njirazi.Iwo ndi ongowafotokozera okha.

Nambala ya NCT Wothandizira Mkhalidwe Tsiku loyambira

Gawo

NCT03998176 Yunivesite ya Nebraska | Gileadi Sayansi HIV-1 - matenda October 9, 2019

Gawo 4

NCT03789968 Thomas Jefferson University|University of Maryland, College Park|Indiana University Health|The Brooklyn Hospital Center|University of Illinois ku Chicago|Nova Southeastern University|University of California, San Francisco HIV + Edzi Seputembara 1, 2019
NCT04249037 Yunivesite ya Colorado, Denver | Gileadi Sayansi HIV + Edzi Marichi 1, 2020

Zosafunika

NCT04132674 Vancouver Infectious Diseases Center Human Immunodeficiency Virus I Infection| Kugwiritsa Ntchito Mankhwala Osokoneza Bongo Novembala 26, 2018

Gawo 4

NCT04054089 Cristina Mussini|University of Modena ndi Reggio Emilia Matenda a HIV Seputembara 2019

Gawo 4

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

Gawo 3

NCT02275065 Sayansi ya Gileadi Kachilombo ka HIV-1 October 2014

Gawo 1

NCT03711253 Yunivesite ya Southern California Kachilombo ka HIV October 14, 2019

Gawo 4

NCT02400307 Sayansi ya Gileadi HIV Epulo 17, 2015

Gawo 1

NCT03499483 Fenway Community Health Kupewa HIV Januware 24, 2019

Gawo 4

NCT03502005 Midland Research Group, Inc.|Gileadi Sciences Human Immunodeficiency Virus Marichi 1, 2018

Gawo 4

Kapangidwe ka mankhwala

Bictegravir-1611493-60-7

CERTIFICATE

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

KUSINTHA KWA KHALIDWE

Quality management1

Malingaliro18Ma projekiti a Quality Consistency Evaluation omwe avomereza4,ndi6mapulojekiti akuvomerezedwa.

Quality management2

Njira zotsogola zapadziko lonse lapansi zoyendetsera bwino zakhazikitsa maziko olimba pakugulitsa.

Quality management3

Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zabwino ndi zochiritsira.

Quality management4

Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.

MANAGEMENT ZOPHUNZITSA

cpf5
cpf6

Korea Countec Bottled Packaging Line

cpf7
cpf8

Taiwan CVC Bottled Packaging Line

cpf9
cpf10

Italy CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Japan Viswill Tablet Detector

cpf14-1

Chipinda chowongolera cha DCS

WOTHANDIZA

Mgwirizano wapadziko lonse lapansi
International cooperation
Mgwirizano wapakhomo
Domestic cooperation

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