Daclatasvir Dihydrochloride

Ibisobanuro bigufi:

Izina rya API Kwerekana Ibisobanuro DMF yo muri Amerika EU DMF CEP
Daclatasvir Dihydrochloride HCV Mu nzu    


Ibisobanuro birambuye

Ibiranga ibicuruzwa

KUBONA UMUSARURO

Ibisobanuro

Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) ni imbaraga kandi ikora mumanwaPoroteyine ya HCV NS5Ainhibitor hamweEC50s Urutonde rwa 9-146 pM kurigenotypes nyinshi za HCV.Daclatasvir dihydrochloride nayo ni aanion organic itwara polypeptide 1B (OATP1B)naOATP1B3inhibitor hamweIC50s ya 1.5 µM na 3.27 µM.

IC50& Intego

EC50: 50 pM (genotype ya HCV 1a), 9 pM (genotype ya HCV ya 1b), 71 pM HCV ikoporora genotype 5a)[1]
Kd: 8 nM (NS5A33-202) na 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) na 3.27 µM (OATP1B3)[3]

Muri Vitro

Daclatasvir (BMS-790052) yerekana ibikorwa bikomeye byo kubuza genotypes zose zapimwe, hamwe na EC50indangagaciro kuva kuri 9 pM kugeza 146 pM.Daclatasvir ibuza genotype ya HCV 1a, 1b, 2a, 3a, 4a na 5a hamwe na EC50indangagaciro za 50 pM, 9 pM, 71 pM, 146 pM, 12 pM na 33 pM.Daclatasvir ninzitizi ikomeye ya JFH-1 genotype 2a virusi yandura yigana mumico ya selile (EC50= 28 pM)[1].Daclatasvir (BMS-790052) ihuza cyane na NS5A33-202 na NS5A26-202 hamwe na Kds ya 8 nM na 210 nM[2].

Ububiko

Ifu

-20 ° C.

Imyaka 3
 

4 ° C.

Imyaka 2
Mubishobora

-80 ° C.

Amezi 6
 

-20 ° C.

Ukwezi


Ikigeragezo cya Clinical

Umubare wa NCT Umuterankunga Imiterere Itariki yo gutangiriraho

Icyiciro

NCT03369327 Ishuri Rikuru ryubuvuzi rya Tehran | Uruganda rukora imiti ya RojanPharma Indwara ya Hepatitis C Yanduye, Igisubizo cyo Kuvura | Virusi ya Immunodeficiency ya muntu Ku ya 1 Mutarama 2017

Icyiciro cya 3

NCT03485846 R-Pharm | Almedis Indwara ya Hepatite idakira C Genotype 1b Ku ya 27 Ugushyingo 2017

Icyiciro cya 2

NCT01016912 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2009

Icyiciro cya 2

NCT01629732 Bristol-Myers Squibb Virusi ya Hepatite C. Werurwe 2013

Icyiciro cya 2

NCT01497834 Bristol-Myers Squibb Indwara ya Hepatite C. Mutarama 2012

Icyiciro cya 3

NCT01973049 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2013

Icyiciro cya 3

NCT00663208 Bristol-Myers Squibb Indwara ya Hepatite idakira C. Gicurasi 2008

Icyiciro cya 2

NCT02576314 Ikigo cyubushakashatsi bwubuzima nubuzima | Beijing 302 Ibitaro Indwara ya Hepatite C idakira Gicurasi 2015

Icyiciro cya 3

NCT02756936 Ikigo Cyukuri Cyubushakashatsi, Misiri | Zeta Pharma Pharmaceutical Industries Amagara mazima Gashyantare 2016

Icyiciro cya 1

NCT02771405 National Hepatology & Tropical Medicine Research Institute | Kaminuza ya Cairo Indwara ya Hepatite C, karande | Kanseri ya Hepatocellular Werurwe 2016

Icyiciro cya 3

NCT03706898 Viriom VIH-1-kwandura | Ubumuga bwo mu nda Ku ya 1 Ukwakira 2018

Icyiciro cya 1

NCT02319031 Bristol-Myers Squibb Indwara ya Hepatite C. Gashyantare 2015

Icyiciro cya 3

NCT02124044 Ikigo cyigihugu cyubuzima Clinical Centre (CC) | Ikigo cyigihugu gishinzwe allergie nindwara zanduza (NIAID) | Bristol-Myers Squibb VIH-HCV Gashyantare 2014

Icyiciro cya 2

NCT02551861 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2015

Icyiciro cya 2

NCT00859053 Bristol-Myers Squibb Indwara idahagije Werurwe 2009

Icyiciro cya 1

NCT01257204 Bristol-Myers Squibb Virusi ya Hepatite C. Ukuboza 2010

Icyiciro cya 2

NCT03063879 Ishuri Rikuru ry'Ubuvuzi rya Tehran | Ahvaz Jundishapur University of Science Science | Shiraz University of Science Science | Hamadan University of Medical Science Indwara ya Hepatite C, idakira | Kunanirwa kw'impyiko zidakira Ku ya 1 Mata 2017

Icyiciro cya 4

NCT01017575 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2009

Icyiciro cya 2

NCT02865369 Sang Gyune Kim | Ibitaro bya kaminuza ya Seoul ya Boramae | Ibitaro bya Severance | Ibitaro bya kaminuza ya Inha | Kaminuza ya Koreya | Ibitaro by’ubuvuzi bya kaminuza ya Gachon | Ibitaro bya kaminuza ya Hanyang | Ibitaro bya Ewha Womans | Indwara ya Hepatite idakira C. Nzeri 2016

NCT04070235 Nanjing Sanhome Pharmaceutical, Co, Ltd. Indwara ya Hepatite C, idakira Ku ya 29 Werurwe 2019

Icyiciro cya 2 | Icyiciro cya 3

NCT03487848 Bristol-Myers Squibb Indwara ya Hepatite C | Indwara ya Hepatite idakira Ku ya 18 Gicurasi 2018

Icyiciro cya 2

NCT00904059 Bristol-Myers Squibb Indwara ya Hepatite C. Gicurasi 2009

Icyiciro cya 1

NCT02107365 Ikigo cy’igihugu cy’ubuzima n’ubushakashatsi mu Bufaransa-Ikigo cy’igihugu cy’Ubufaransa gishinzwe ubushakashatsi kuri sida na virusi ya Hepatite (Inserm-ANRS) | Bristol-Myers Squibb Indwara ya Hepatite C Virusi Yanduye 4 Ugushyingo 2013

Icyiciro cya 2

NCT02397395 Janssen R&D Irlande Kutagira Impyiko | Indwara yanyuma-Indwara Gicurasi 2015

Icyiciro cya 2

NCT03169348 Kaminuza ya Assiut Indwara ya Hepatite C. Ku ya 1 Ugushyingo 2017

Ntabwo ari ngombwa

NCT02323594 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2014

Icyiciro cya 1

NCT03537196 Ikigo cy’igihugu cy’ubuzima n’ubushakashatsi mu Bufaransa-Ikigo cy’igihugu cy’Ubufaransa gishinzwe ubushakashatsi kuri SIDA na Hepatite ya virusi (Inserm-ANRS) Indwara ya Hepatite C | Gukoresha ibiyobyabwenge | Indwara ya Hepatite C. Ku ya 13 Ugushyingo 2018

Icyiciro cya 4

NCT02103569 Bristol-Myers Squibb Indwara ya Hepatite C. Mata 2014

Icyiciro cya 1

NCT02772744 Kaminuza ya Zagazig | Kaminuza ya Cairo Indwara ya Hepatite C. Ku ya 1 Ugushyingo 2017

NCT01718158 Bristol-Myers Squibb Indwara ya Hepatite C. Mutarama 2013

Icyiciro cya 3

NCT02496078 Bristol-Myers Squibb Indwara ya Hepatite C. Kanama 2015

Icyiciro cya 3

NCT01425970 Bristol-Myers Squibb Indwara ya Hepatite C. Gicurasi 2012

Icyiciro cya 2

NCT01471574 Bristol-Myers Squibb Indwara ya Hepatite C, Ubwoko bwa 1 Ukuboza 2011

Icyiciro cya 3

NCT01573351 Bristol-Myers Squibb Virusi ya Hepatite C. Gicurasi 2012

Icyiciro cya 3

NCT01938625 Janssen R&D Irlande Indwara ya Hepatite C, idakira Ku ya 12 Ukuboza 2013

Icyiciro cya 2

NCT01492426 Bristol-Myers Squibb Indwara ya Hepatite C. Mutarama 2012

Icyiciro cya 3

NCT03480932 Johns Hopkins Bloomberg Ishuri ryubuzima rusange | Ikigo cyigihugu gishinzwe kurwanya ibiyobyabwenge (NIDA) | Ikigo cya YR Gaitonde gishinzwe ubushakashatsi nuburezi kuri sida Indwara ya Hepatite C, idakira Ku ya 2 Gashyantare 2018

Icyiciro cya 2 | Icyiciro cya 3

NCT03163849 Kaminuza ya Assiut Indwara ya Hepatite idakira c Ku ya 1 Nzeri 2019

Icyiciro cya 3

NCT01581203 Bristol-Myers Squibb Virusi ya Hepatite C. Gicurasi 2012

Icyiciro cya 3

NCT01492504 Bristol-Myers Squibb Indwara ya Hepatite C. Ku ya 7 Gashyantare 2012

NCT03686722 Mohamed Raslan | Ain Shams University | Ikigo cy’ubushakashatsi ku biyobyabwenge, Cairo, Misiri Indwara ya Diyabete, Ubwoko bwa 2 | Indwara ya Hepatite C | Imiti Ku ya 9 Nzeri 2017

Icyiciro cya 1

NCT02262728 Janssen Ubushakashatsi & Iterambere, LLC Indwara ya Hepatite C, idakira Ku ya 30 Nzeri 2014

Icyiciro cya 2

NCT02349048 Janssen Ubushakashatsi & Iterambere, LLC Virusi ya Hepatite C. Mutarama 2015

Icyiciro cya 2

NCT03882307 Kaminuza ya Assiut Indwara ya Hepatite C, idakira Gicurasi 2020

Icyiciro cya mbere

NCT02758509 Parc de Salut Mar Indwara ya Hepatite idakira C | Cirrhose Ku ya 1 Mutarama 2010

NCT01795911 Bristol-Myers Squibb Indwara ya Hepatite C. Werurwe 2013

Icyiciro cya 2

NCT03549832 Kaminuza ya Assiut | Kaminuza ya Sohag | Kaminuza yo mu majyepfo Guhuza HCV Ku ya 1 Mutarama 2018

Ntabwo ari ngombwa

NCT02161939 Bristol-Myers Squibb Indwara ya Hepatite idakira C.  

NCT01309932 Bristol-Myers Squibb Indwara ya Hepatite C. Werurwe 2011

Icyiciro cya 2

NCT01995266 Bristol-Myers Squibb Indwara ya Hepatite C. Ku ya 28 Gashyantare 2014

Icyiciro cya 3

NCT02640157 AbbVie Indwara ya Hepatite idakira C | Virusi ya Hepatite C | Genotype ya 3 Hepatite C. Ukuboza 2015

Icyiciro cya 3

NCT02032875 Bristol-Myers Squibb Indwara ya Hepatite C. Werurwe 2014

Icyiciro cya 3

NCT02624063 Kaminuza nkuru ya São Paulo Indwara ya Hepatite C, idakira Ukuboza 2015

Icyiciro cya 4

NCT00546715 Bristol-Myers Squibb Indwara ya Hepatite idakira C. Ugushyingo 2007

Icyiciro cya 1 | Icyiciro cya 2

NCT01718145 Bristol-Myers Squibb Indwara ya Hepatite C Yanduye Ugushyingo 2012

Icyiciro cya 3

NCT01616524 Bristol-Myers Squibb Virusi ya Hepatite C (HCV) Nyakanga 2012

Icyiciro cya 3

NCT02032901 Bristol-Myers Squibb Indwara ya Hepatite C. Mutarama 2014

Icyiciro cya 3

NCT03540212 Kaminuza ya Ain Shams Indwara idakira ya HCV Ku ya 10 Ukuboza 2017

Icyiciro cya 2 | Icyiciro cya 3

NCT02097966 Bristol-Myers Squibb Indwara ya Hepatite idakira C.  

NCT02596880 Ishuri Rikuru ry'Ubuvuzi rya Tehran Indwara ya Hepatite C | Cirrhose Nzeri 2015

Icyiciro cya 3

NCT04019717 Atea Pharmaceuticals, Inc. Indwara ya Hepatite C | Indwara ya Hepatite C, idakira | Indwara ya Hepatite idakira C | Indwara ya Hepatite C | Indwara ya HCV Ku ya 20 Kamena 2019

Icyiciro cya 2

NCT02992457 Kaminuza ya Tanta Indwara ya Hepatite C. Mutarama 2015

Icyiciro cya 4

NCT03547895 Kaminuza ya Zagazig Indwara ya Cirrhose Ku ya 1 Kamena 2015

Ntabwo ari ngombwa

NCT03004625 Ibitaro by’Urwibutso rwa Kaohsiung Chung-Ho | Ibitaro by’Urwibutso rwa Chang Gung | Ibitaro bya Kaminuza bya Tayiwani | Ibitaro Bikuru by’abasirikare ba Taipei, Tayiwani | Ibitaro bya Kaminuza by’ubuvuzi mu Bushinwa | Ibitaro bya Kaminuza bya Cheng-Kung Indwara ya Hepatite C. Ugushyingo 2016

Icyiciro cya 3

NCT01051414 Bristol-Myers Squibb Indwara ya Hepatite C. Mata 2010

Icyiciro cya 2

NCT02309450 Ikigo cy’igihugu cy’ubuzima n’ubushakashatsi mu Bufaransa-Ikigo cy’igihugu cy’Ubufaransa gishinzwe ubushakashatsi kuri sida na virusi ya Hepatite (Inserm-ANRS) | Bristol-Myers Squibb Indwara ya Hepatite C Virusi Yanduye 4 Ukuboza 2014

Icyiciro cya 2

NCT01628692 Bristol-Myers Squibb | Janssen Ubushakashatsi & Iterambere, LLC Virusi ya Hepatite C. Nyakanga 2012

Icyiciro cya 2

NCT03186313 Ibitaro byumwijima byo muri Egiputa | Ibitaro bya Wadi El Nil Indwara ya Hepatite C. Nzeri 2016

Icyiciro cya 3

NCT03063723 Ibitaro bya gatatu bishamikiyeho, Sun Yat-Sen University Indwara ya Hepatite idakira C (Disorder) Ku ya 1 Mutarama 2016

NCT00983957 Bristol-Myers Squibb Indwara ya Hepatite idakira C. Ukwakira 2009

Icyiciro cya 1

NCT01725542 Ikigo cy’igihugu cy’ubuzima n’ubushakashatsi mu Bufaransa-Ikigo cy’igihugu cy’Ubufaransa gishinzwe ubushakashatsi kuri sida na virusi ya Hepatite (Inserm-ANRS) | Bristol-Myers Squibb Kwandura HCV-VIH Ukuboza 2012

Icyiciro cya 2

NCT02282709 Urufatiro rwubushakashatsi bwumwijima Indwara ya Hepatite idakira C. Gashyantare 2014

Icyiciro cya 3

NCT02032888 Bristol-Myers Squibb Indwara ya Hepatite C. Gashyantare 2014

Icyiciro cya 3

NCT03247296 Kaminuza ya MTI Indwara ya Hepatite C. Ku ya 28 Gashyantare 2017

NCT01389323 Bristol-Myers Squibb Indwara ya Hepatite C. Nzeri 2011

Icyiciro cya 3

NCT02556086 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2015

Icyiciro cya 2

NCT01741545 Bristol-Myers Squibb Virusi ya Hepatite C. Ku ya 31 Werurwe 2013

Icyiciro cya 3

NCT01866930 Bristol-Myers Squibb Indwara ya Hepatite C idakira Ku ya 11 Nyakanga 2013

Icyiciro cya 3

NCT02268864 Janssen-Cilag Mpuzamahanga NV Indwara ya Hepatite C, idakira Mutarama 2015

Icyiciro cya 2

NCT01797848 Bristol-Myers Squibb Indwara ya Hepatite C. Kamena 2014

Icyiciro cya 3

NCT03166280 Eman Sayed Hassan Abd Allah | Kaminuza ya Assiut Indwara ya Hepatite C. Kamena 2017

NCT02159352 Bristol-Myers Squibb Indwara ya Hepatite C. Kamena 2014

Icyiciro cya 1

NCT01125189 Bristol-Myers Squibb Virusi ya Hepatite C. Nyakanga 2010

Icyiciro cya 2

NCT03748745 Nanjing Sanhome Pharmaceutical, Co, Ltd. Imikoreshereze yibiyobyabwenge Ku ya 19 Ugushyingo 2018

Icyiciro cya 1

NCT01012895 Bristol-Myers Squibb Indwara ya Hepatite idakira C. Ukuboza 2009

Icyiciro cya 2

NCT02565888 Kaminuza ya Radboud Indwara ya Hepatite C | VIH Ugushyingo 2015

Icyiciro cya 1

NCT02555943 Ikigo cyubushakashatsi bwubuzima nubuzima | Beijing 302 Ibitaro | Ibitaro bya Nanfang bya kaminuza yubuvuzi bwamajyepfo Indwara ya Hepatite C idakira | Guhuza HBV | Hepatite B Reactivation Gashyantare 2015

Icyiciro cya 2 | Icyiciro cya 3

NCT02304159 Tarek I. Hassanein, MD, FACP, FAG, AGAF | Ikigo cy’ubushakashatsi cya Californiya Indwara ya Hepatite C | Cirrhose Mutarama 2015

Icyiciro cya 4

NCT02580474 Indirimbo ya Myeong Jun | Bristol-Myers Squibb | Ibitaro bya Kaminuza ya Soonchunhyang | Dankook | Ibitaro bya Kaminuza bya Chungnam | Ibitaro bya Koniang | Ibitaro bya Kaminuza bya Eulji | , Koreya | Ibitaro bya Severance | Ibitaro bya Kaminuza bya Koreya | Ibitaro Bikuru bya Eulji | Kaminuza Gatolika ya Koreya Indwara ya Hepatite C. Gashyantare 2016

Icyiciro cya 4

NCT02104843 Bristol-Myers Squibb Indwara ya Hepatite C. Mata 2014

Icyiciro cya 1

NCT01428063 Bristol-Myers Squibb Indwara ya Hepatite C Yanduye Nzeri 2011

Icyiciro cya 2

NCT02123654 Bristol-Myers Squibb Indwara ya Hepatite C Yanduye Mata 2014

Icyiciro cya 3

NCT02565862 Kaminuza ya Radboud Indwara ya Hepatite C | Indwara ya Diyabete | Kurwanya insuline Mutarama 2016

Icyiciro cya 1

NCT04211844 Kaminuza ya Ain Shams Indwara ya Hepatite idakira C. Ku ya 1 Ukwakira 2019

NCT00874770 Bristol-Myers Squibb Indwara ya Hepatite C. Kamena 2009

Icyiciro cya 2

NCT03883698 Ishuri Rikuru ry'Ubuvuzi rya Sanjay Gandhi Kunanirwa kw'impyiko, karande | Hepatite C. Ku ya 15 Werurwe 2019

Icyiciro cya 3

NCT01448044 Bristol-Myers Squibb Indwara ya Hepatite C. Ukuboza 2011

Icyiciro cya 3

NCT01359644 Bristol-Myers Squibb | Pharmasset Indwara ya Hepatite idakira C. Kamena 2011

Icyiciro cya 2

NCT01842451 Imiti ya Vertex Yashizwemo Indwara ya Hepatite idakira C | CHC | HCV | Indwara ya Hepatite C. Kamena 2013

Icyiciro cya 2

NCT02762448 Ibitaro bya Komine ya Tainan Indwara ya Hepatite c Nyakanga 2016

NCT02473211 Ikigo cyubushakashatsi bwubuzima nubuzima | Beijing 302 Ibitaro Indwara ya Hepatite C idakira Mutarama 2015

Icyiciro cya 2 | Icyiciro cya 3

NCT01455090 Bristol-Myers Squibb Indwara ya Hepatite idakira C. Ku ya 30 Ugushyingo 2011

Icyiciro cya 2

NCT03490097 Kaminuza ya Ain Shams Indwara ya Hepatite idakira c | Indwara ya Metabolic Ku ya 1 Ukuboza 2017

Icyiciro cya 2 | Icyiciro cya 3

NCT01170962 Bristol-Myers Squibb Virusi ya Hepatite C. Kanama 2010

Icyiciro cya 2

NCT02333292 Ibitaro bya Kaminuza bya Valme | Ibitaro del SAS de Jerez | Ibitaro Bikuru bya Universitario Elche | Ibitaro La Línea de la Concepción | Complexo Hospitalario Universitario de A Coruña | Ibitaro bya Figueres | Ibitaro Universitario Puerto Real | Ibitaro Universitario Virgen de la Victoria | Ibitaro Universitario de Canarias | Ibitaro Bikuru bya Universitario de Alicante | Ibitaro Universitario Araba | Ibitaro Royo Vilanova | Ibitaro Universitario de Burgos | Complejo Hospitalario Universitario de Huelva | Ibitaro Universitario Reina Sofia de Cordoba | Ibitaro Universitario Virgen Macarena | Complexo Hospitalario Universitario de Vigo | Clinica Universidad de Navigo | Navarra | Ibitaro Clinico Universitario San Cecilio | Ibitaro Universitario La Fe | Ibitaro Bikuru Universitario de Valencia | Ibitaro Universitario Infanta Leonor | Ibitaro Universitario de Gran Canaria | Ibitaro Bikuru bya Universitario Santa Lucía | Centro Penitenciario Alicante 1 | Ibitaro bya Universitario Carlos Haya | la L.uz | Ibitaro Bikuru bya Universitario de Castellón | Ibitaro Parc Taulí, Sabadell Indwara ya Hepatite C idakira Ukuboza 2014

NCT03200184 Ishuri Rikuru ry'Ubuvuzi rya Tehran Indwara ya Hepatite C. Ku ya 1 Nzeri 2016

Icyiciro cya 4

NCT03188276 Ibitaro bya gatatu bishamikiyeho, Sun Yat-Sen University Indwara ya Hepatite idakira C. Ku ya 1 Gashyantare 2016

Icyiciro cya mbere

NCT01830205 Bristol-Myers Squibb Indwara ya Hepatite C. Nzeri 2012

Icyiciro cya 1

 

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

Gucunga neza

Quality management1

Icyifuzo18Imishinga yo gusuzuma ireme ryemejwe4, na6imishinga iremezwa.

Quality management2

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Quality management3

Igenzura ryiza rinyura mubuzima bwose bwibicuruzwa kugirango hamenyekane ingaruka nziza nubuvuzi.

Quality management4

Itsinda ryumwuga ushinzwe kugenzura ibikorwa byujuje ubuziranenge mugihe cyo gusaba no kwiyandikisha.

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