Daclatasvir Dihydrochloride

Sharax Gaaban:

Magaca API Tilmaam Faahfaahinta US DMF  EU DMF  CEP
Daclatasvir Dihydrochloride HCV Guriga Gudihiisa    

Faahfaahinta alaabta

Calaamadaha alaabta

FAAHFAAHINTA SOO SAARKA

Sharaxaad

Daclatasvir dihydrochloride (BMS-790052 dihydrochloride) waa karti iyo hadal firfircoon HCV NS5A protein ka hortage leh EC50s kala duwan oo ah 9-146 pM for noocyo badan oo nuqul HCV ah. Daclatasvir dihydrochloride sidoo kale waa a anion qaadista polypeptide 1B (OATP1B) iyo OATP1B3 ka hortage leh IC50s ee 1.5 µM iyo 3.27 µM, siday u kala horreeyaan.

IC50 & Bartilmaameed

EC50: 50 pM (HCV replicon genotype 1a), 9 pM (HCV replicon genotype 1b), 71 pM (HCV replicon genotype 2a), 146 pM (HCV replicon genotype 3a), 12 pM (HCV replicon genotype 4a) and 33 pM (33M MB) HCV nooca genotype 5a)[1]
Kd: 8 nM (NS5A33-202) iyo 210 nM (NS5A26-202)[2]
IC50: 1.5 µM (OATP1B) iyo 3.27 µM (OATP1B3)[3]

In Vitro

Daclatasvir (BMS-790052) wuxuu muujiyaa waxqabad xoog leh oo kahortag ah dhammaan noocyada genotypes ee la baaray, EC50 qiimaha u dhexeeya 9 pM ilaa 146 pM. Daclatasvir wuxuu xakameynayaa nooca HCV ee genotype 1a, 1b, 2a, 3a, 4a iyo 5a oo leh EC50 qiyamka 50 pM, 9 pM, 71 pM, 146 pM, 12 pM iyo 33 pM, siday u kala horreeyaan. Daclatasvir waa kahortag awood leh JFH-1 genotype 2a virus faafa oo ku celceliya dhaqanka unugyada (EC50= 28 pM)[1]. Daclatasvir (BMS-790052) wuxuu si adag ugu xiraa NS5A33-202 iyo NS5A26-202 oo leh Kds ee 8 nM iyo 210 nM, siday u kala horreeyaan[2].

Kaydinta

Budada

-20 ° C

3 sano
 

4 ° C

2 sano
Kala dareeraha

-80 ° C

6 bilood
 

-20 ° C

1 bil


Tijaabada Caafimaadka

Lambarka NCT Kafaalasho Xaaladda Taariikhda billowga

Wejiga

NCT03369327 Jaamacadda Tehran ee Sayniska Caafimaadka | Shirkadda Dawooyinka ee RojanPharma Cudurka Cagaarshowga C Cagaarshowga C, Jawaabta Daaweynta | Fayraska Tallaalka Bani-aadamka Janaayo 1, 2017

Wejiga 3

NCT03485846 R-Pharm | Almedis Cagaarshowga Cagaarshowga C Genotype 1b Nofeembar 27, 2017

Wajiga 2

NCT01016912 Bristol-Myers Squibb Cudurka Cagaarshowga C Diisambar 2009

Wajiga 2

NCT01629732 Bristol-Myers Squibb Fayraska Cagaarshowga C Maarso 2013

Wajiga 2

NCT01497834 Bristol-Myers Squibb Cagaarshowga C Janaayo 2012

Wejiga 3

NCT01973049 Bristol-Myers Squibb Cagaarshowga C Diisambar 2013

Wejiga 3

NCT00663208 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C Bishii Meey 2008

Wajiga 2

NCT02576314 Bini'aadamka iyo Xarunta Cilmi-baarista Caafimaadka | Isbitaalka Beijing 302 Infekshinka Cagaarshowga C Laga yaabaa 2015

Wejiga 3

NCT02756936 Xarunta Cilmi Baarista Dhabta ah, Masar | Warshadaha Daawooyinka ee Zeta Pharma Caafimaad qab ah Febraayo 2016

Wajiga 1

NCT02771405 Machadka Cilmi-baarista Cilmiga Cudurka & Cimilada Tropical | Jaamacadda Qaahira Cagaarshowga C, Joogtada ah | Cagaarshowga Cagaarshowga Maarso 2016

Wejiga 3

NCT03706898 Viriom HIV-1-infekshan | Naafada Cagaarshowga Oktoobar 1, 2018

Wajiga 1

NCT02319031 Bristol-Myers Squibb Cagaarshowga C Febraayo 2015

Wejiga 3

NCT02124044 Machadyada Qaranka ee Xarunta Caafimaadka (CC) | Machadka Qaranka ee Xasaasiyadda iyo Cudurada faafa (NIAID) | Bristol-Myers Squibb HIV-HCV Febraayo 2014

Wajiga 2

NCT02551861 Bristol-Myers Squibb Cagaarshowga C Diisambar 2015

Wajiga 2

NCT00859053 Bristol-Myers Squibb Cudurka Cagaarshowga Maarso 2009

Wajiga 1

NCT01257204 Bristol-Myers Squibb Fayraska Cagaarshowga C Diisambar 2010

Wajiga 2

NCT03063879 Jaamacadda Tehran ee Sayniska Caafimaadka | Ahvaz Jundishapur Jaamacadda Cilmiga Caafimaadka | Jaamacadda Shiraz ee Sayniska Caafimaadka | Jaamacadda Hamadan ee Sayniska Caafimaadka Cagaarshowga C, Cudurka Joogtada ah Abriil 1, 2017

Wejiga 4

NCT01017575 Bristol-Myers Squibb Cudurka Cagaarshowga C Diisambar 2009

Wajiga 2

NCT02865369 Sang Gyune Kim | Jaamacadda Qaranka Seoul ee Boorama | Isbitaalka Severance | Isbitaalka Jaamacadda Inha | Jaamacadda Kuuriya | Jaamacadda Gachon University Gil Medical | Hanyang University Seoul Hospital | Ewha Womans University Mokdong Hospital | Bristol-Myers Squibb | Soonchunhyang University Hospital Cagaarshowga Cagaarshowga C Sebtember 2016

NCT04070235 Nanjing Sanhome Pharmaceutical, Co., Ltd. Cagaarshowga C, Chronic 29-Mar-2019

Wajiga 2 | Wajiga 3

NCT03487848 Bristol-Myers Squibb Cagaarshowga C | Cagaarshowga joogtada ah 18-May-2018

Wajiga 2

NCT00904059 Bristol-Myers Squibb Cagaarshowga C Bishii Meey 2009

Wajiga 1

NCT02107365 Machadka Qaranka ee Caafimaadka iyo Cilmi-baarista Caafimaadka-Hay'adda Qaranka ee Faransiiska ee Cilmi-baarista AIDS-ka iyo Cagaarshowga Feyraska (Inserm-ANRS) | Bristol-Myers Squibb Hepatitis C Virus Genotype 4 Infection Nofeembar 2013

Wajiga 2

NCT02397395 Janssen R&D Ireland Naafada Kelyaha | Cudurka Kelyaha ee marxaladda ugu dambeysa Laga yaabaa 2015

Wajiga 2

NCT03169348 Jaamacadda Assiut Cagaarshowga C Nofeembar 1, 2017

Ma khuseyso

NCT02323594 Bristol-Myers Squibb Cudurka Cagaarshowga C Diisambar 2014

Wajiga 1

NCT03537196 Machadka Qaranka ee Caafimaadka iyo Cilmi-baarista Caafimaadka-Wakaaladda Qaranka ee Faransiiska ee Cilmi-baarista AIDS-ka iyo Cagaarshowga Feyraska (Inserm-ANRS) Cagaarshowga C | Isticmaalka Daroogada | Cagaarshowga Cagaarshowga C Nofeembar 13, 2018

Wejiga 4

NCT02103569 Bristol-Myers Squibb Cagaarshowga C Abriil 2014

Wajiga 1

NCT02772744 Jaamacadda Zagazig | Jaamacadda Qaahira Cagaarshowga C Nofeembar 1, 2017

NCT01718158 Bristol-Myers Squibb Cagaarshowga C Janaayo 2013

Wejiga 3

NCT02496078 Bristol-Myers Squibb Cagaarshowga C Ogast 2015

Wejiga 3

NCT01425970 Bristol-Myers Squibb Cagaarshowga C Maajo 2012

Wajiga 2

NCT01471574 Bristol-Myers Squibb Cagaarshowga C, Genotype 1 Diisambar 2011

Wejiga 3

NCT01573351 Bristol-Myers Squibb Fayraska Cagaarshowga C Maajo 2012

Wejiga 3

NCT01938625 Janssen R&D Ireland Cagaarshowga C, Chronic Diisambar 12, 2013

Wajiga 2

NCT01492426 Bristol-Myers Squibb Cagaarshowga C Janaayo 2012

Wejiga 3

NCT03480932 Johns Hopkins Bloomberg Iskuulka Caafimaadka Dadweynaha | Machadka Qaranka ee Xad-gudubka Daroogada (NIDA) | YR Gaitonde Xarunta Cilmi-baarista iyo Waxbarashada AIDS Cagaarshowga C, Chronic Febraayo 2, 2018

Wajiga 2 | Wajiga 3

NCT03163849 Jaamacadda Assiut Cagaarshowga joogtada ah c Sebtember 1, 2019

Wejiga 3

NCT01581203 Bristol-Myers Squibb Fayraska Cagaarshowga C Maajo 2012

Wejiga 3

NCT01492504 Bristol-Myers Squibb Cagaarshowga C Febraayo 7, 2012

NCT03686722 Maxamed Raslan | Jaamacadda Ain Shams | Xarunta Cilmi baarista Daroogada, Qaahira, Masar Sonkorowga Mellitus, Nooca 2 | Cagaarshowga C | Isdhexgalka Daroogada Sebtember 9, 2017

Wajiga 1

NCT02262728 Janssen Cilmi baarista & Horumarinta, LLC Cagaarshowga C, Chronic Sebtember 30, 2014

Wajiga 2

NCT02349048 Janssen Cilmi baarista & Horumarinta, LLC Fayraska Cagaarshowga C Janaayo 2015

Wajiga 2

NCT03882307 Jaamacadda Assiut Cagaarshowga C, Chronic Laga yaabaa 2020

Wajiga Hore 1

NCT02758509 Parc de Salut Mar Cagaarshowga Cagaarshowga C | Cirrhosis Janawari 1, 2010

NCT01795911 Bristol-Myers Squibb Cagaarshowga C Maarso 2013

Wajiga 2

NCT03549832 Jaamacadda Assiut | Jaamacadda Sohag | Jaamacadda South Valley Daawada HCV Janaayo 1, 2018

Ma khuseyso

NCT02161939 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C  

NCT01309932 Bristol-Myers Squibb Cagaarshowga C Maarso 2011

Wajiga 2

NCT01995266 Bristol-Myers Squibb Cagaarshowga C Febraayo 28, 2014

Wejiga 3

NCT02640157 AbbVie Cagaarshowga Cagaarshowga C | Hepatitis C Virus | Genotype 3 Hepatitis C Virus Diisambar 2015

Wejiga 3

NCT02032875 Bristol-Myers Squibb Cagaarshowga C Maarso 2014

Wejiga 3

NCT02624063 Jaamacadda Federaalka ee São Paulo Cagaarshowga C, Chronic Diisambar 2015

Wejiga 4

NCT00546715 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C Nofeembar 2007

Wajiga 1 | Wajiga 2

NCT01718145 Bristol-Myers Squibb Cudurka Cagaarshowga C Nofeembar 2012

Wejiga 3

NCT01616524 Bristol-Myers Squibb Fayraska Cagaarshowga C (HCV) Julaay 2012

Wejiga 3

NCT02032901 Bristol-Myers Squibb Cagaarshowga C Janaayo 2014

Wejiga 3

NCT03540212 Jaamacadda Ain Shams Infekshinka HCV ee joogtada ah Diisambar 10, 2017

Wajiga 2 | Wajiga 3

NCT02097966 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C  

NCT02596880 Jaamacadda Tehran ee Sayniska Caafimaadka Cagaarshowga C | Cirrhosis Sebtember 2015

Wejiga 3

NCT04019717 Daawooyinka Atea, Inc. Cagaarshowga C | Cagaarshowga C, Xanuun | Cagaarshowga Cagaarshowga C | Cudurka Cagaarshowga C Cudurka Cudurka HCV 20 Juunyo 2019

Wajiga 2

NCT02992457 Jaamacadda Tanta Cagaarshowga C Janaayo 2015

Wejiga 4

NCT03547895 Jaamacadda Zagazig Cirrhosis Wareegsan Juun 1, 2015

Ma khuseyso

NCT03004625 Kaohsiung University Medical University Chung-Ho Memorial Hospital Cagaarshowga C Nofeembar 2016

Wejiga 3

NCT01051414 Bristol-Myers Squibb Cudurka Cagaarshowga C Abriil 2010

Wajiga 2

NCT02309450 Machadka Qaranka ee Caafimaadka iyo Cilmi-baarista Caafimaadka-Hay'adda Qaranka ee Faransiiska ee Cilmi-baarista AIDS-ka iyo Cagaarshowga Feyraska (Inserm-ANRS) | Bristol-Myers Squibb Hepatitis C Virus Genotype 4 Infection Diisambar 2014

Wajiga 2

NCT01628692 Bristol-Myers Squibb | Janssen Cilmi baarista & Horumarinta, LLC Fayraska Cagaarshowga C Julaay 2012

Wajiga 2

NCT03186313 Isbitaalka Beerka ee Masar | Wadi El Nil Hospital Cagaarshowga C Sebtember 2016

Wejiga 3

NCT03063723 Isbitaalka seddexaad ee kuxiran, Sun Yat-Sen University Cagaarshowga Cagaarshowga C 1-Janaayo, 2016

NCT00983957 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C Oktoobar 2009

Wajiga 1

NCT01725542 Machadka Qaranka ee Caafimaadka iyo Cilmi-baarista Caafimaadka-Hay'adda Qaranka ee Faransiiska ee Cilmi-baarista AIDS-ka iyo Cagaarshowga Feyraska (Inserm-ANRS) | Bristol-Myers Squibb HCV-HIV Co-Infection Diisambar 2012

Wajiga 2

NCT02282709 Aasaaska cilmi baarista beerka Cagaarshowga Cagaarshowga C Febraayo 2014

Wejiga 3

NCT02032888 Bristol-Myers Squibb Cagaarshowga C Febraayo 2014

Wejiga 3

NCT03247296 Jaamacadda MTI Cagaarshowga C Febraayo 28, 2017

NCT01389323 Bristol-Myers Squibb Cagaarshowga C Sebtember 2011

Wejiga 3

NCT02556086 Bristol-Myers Squibb Cagaarshowga C Diisambar 2015

Wajiga 2

NCT01741545 Bristol-Myers Squibb Fayraska Cagaarshowga C 31-Maarso, 2013

Wejiga 3

NCT01866930 Bristol-Myers Squibb Infekshinka Cagaarshowga C Julaay 11, 2013

Wejiga 3

NCT02268864 Janssen-Cilag International NV Cagaarshowga C, Chronic Janaayo 2015

Wajiga 2

NCT01797848 Bristol-Myers Squibb Cagaarshowga C Juunyo 2014

Wejiga 3

NCT03166280 Eman Sayed Hassan Abd Allah | Jaamacadda Assiut Cagaarshowga C Juunyo 2017

NCT02159352 Bristol-Myers Squibb Cagaarshowga C Juunyo 2014

Wajiga 1

NCT01125189 Bristol-Myers Squibb Fayraska Cagaarshowga C Julaay 2010

Wajiga 2

NCT03748745 Nanjing Sanhome Pharmaceutical, Co., Ltd. Isdhexgalka Daroogada Nofeembar 19, 2018

Wajiga 1

NCT01012895 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C Diisambar 2009

Wajiga 2

NCT02565888 Jaamacadda Radboud Cagaarshowga C | HIV Nofeembar 2015

Wajiga 1

NCT02555943 Bini'aadamka iyo Xarunta Cilmi-baarista Caafimaadka | Isbitaalka Beijing 302 | Isbitaalka Nanfang ee Jaamacadda Caafimaadka ee Koonfurta Infekshinka Cagaarshowga C ee Xanuunka | HBV Coinfection | Cagaarshowga B. Febraayo 2015

Wajiga 2 | Wajiga 3

NCT02304159 Tarek I. Hassanein, MD, FACP, FAG, AGAF | Xarunta Cilmi baarista ee Koonfurta California Cagaarshowga C | Cirrhosis Janaayo 2015

Wejiga 4

NCT02580474 Myeong Jun Song | Bristol-Myers Squibb | Isbitaalka Jaamacada Soonchunhyang | Dankook University | Chungnam National University Hospital | Isbitaalka Jaamacada Konyang | Isbitaalka Jaamacadda Eulji | Isbitaalka Saint Vincent´s, Kuuriya | Isbitaalka Jaamacadda Konkuk | Cheongju St. Mary´s Hospital, Cheongju , Korea | Isbitaalka Severance | Isbitaalka Jaamacadda Guro ee Kuuriya | Isbitaalka Guud ee Eulji | Jaamacadda Katooliga ee Kuuriya Cagaarshowga C Febraayo 2016

Wejiga 4

NCT02104843 Bristol-Myers Squibb Cagaarshowga C Abriil 2014

Wajiga 1

NCT01428063 Bristol-Myers Squibb Cudurka Cagaarshowga C Sebtember 2011

Wajiga 2

NCT02123654 Bristol-Myers Squibb Cudurka Cagaarshowga C Abriil 2014

Wejiga 3

NCT02565862 Jaamacadda Radboud Cagaarshowga C | Sonkorowga Mellitus | Cadaadiska Insulin Janaayo 2016

Wajiga 1

NCT04211844 Jaamacadda Ain Shams Cagaarshowga Cagaarshowga C Oktoobar 1, 2019

NCT00874770 Bristol-Myers Squibb Cudurka Cagaarshowga C Juunyo 2009

Wajiga 2

NCT03883698 Sanjay Gandhi Machadka Postgraduate ee Sayniska Caafimaadka Ka Fashilida Kelyaha, Joogtada ah | Cagaarshowga C 15-Mar-2019

Wejiga 3

NCT01448044 Bristol-Myers Squibb Cagaarshowga C Diisambar 2011

Wejiga 3

NCT01359644 Bristol-Myers Squibb | Farmasiis Cagaarshowga Cagaarshowga C Juunyo 2011

Wajiga 2

NCT01842451 Daawooyinka Daawooyinka ee 'Vertex Pharmaceuticals Incorporated' Cagaarshowga Cagaarshowga C | CHC | HCV | Cagaarshowga C Juunyo 2013

Wajiga 2

NCT02762448 Isbitaalka Dowlada Hoose ee Tainan Cagaarshow c Julaay 2016

NCT02473211 Bini'aadamka iyo Xarunta Cilmi-baarista Caafimaadka | Isbitaalka Beijing 302 Infekshinka Cagaarshowga C Janaayo 2015

Wajiga 2 | Wajiga 3

NCT01455090 Bristol-Myers Squibb Cagaarshowga Cagaarshowga C Nofeembar 30, 2011

Wajiga 2

NCT03490097 Jaamacadda Ain Shams Cagaarshowga Cagaarshowga C | Cudurka Dheef-shiid kiimikaadka Diisambar 1, 2017

Wajiga 2 | Wajiga 3

NCT01170962 Bristol-Myers Squibb Fayraska Cagaarshowga C Ogast 2010

Wajiga 2

NCT02333292 Isbitaalka Jaamacadda Valme | Isbitaalka del SAS de Jerez | Isbitaalka Guud ee Universitario Elche | Isbitaalka La Línea de la Concepción | Complexo Hospitalario Universitario de A Coruña | Isbitaalka de Figueres | Isbitaalka Universitario Puerto Real | Isbitaalka Universitario Virgen de la Victoria | Isbitaalka Universitario de Canarias | Isbitaalka General Universitario de Alicante | Isbitaalka Universitario Araba | Isbitaalka Royo Vilanova | Isbitaalka Universitario de Burgos | Complejo Hospitalario Universitario de Huelva | Isbitaalka Universitario Reina Sofia de Cordoba | Isbitaalka Universitario Virgen Macarena | Complexo Hospitalario Universitario de Vigo | Clinica Universidad de Navarra, Universidad Navarra | Isbitaalka Clinico Universitario San Cecilio | Isbitaalka Universitario La Fe | Isbitaalka Guud Universitario de Valencia | Isbitaalka Universitario Infanta Leonor | Isbitaalka Universitario de Gran Canaria | Isbitaalka Guud Universitario Santa Lucía | Centro Penitenciario Alicante 1 | Isbitaalka Gobolka Universitario Carlos Haya | Isbitaalka Virgen de la L uz | Isbitaalka Guud Universitario de Castellón | Isbitaalka Parc Taulí, Sabadell Infekshinka Cagaarshowga C Diisambar 2014

NCT03200184 Jaamacadda Tehran ee Sayniska Caafimaadka Cagaarshowga C Sebtember 1, 2016

Wejiga 4

NCT03188276 Isbitaalka seddexaad ee kuxiran, Sun Yat-Sen University Cagaarshowga Cagaarshowga C Febraayo 1, 2016

Wajiga Hore 1

NCT01830205 Bristol-Myers Squibb Cagaarshowga C Sebtember 2012

Wajiga 1

 

SHAHAADO

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

MAAMULKA TAYO

Quality management1

Soo jeedin 18 Mashaariicda Qiimaynta Joogtada Tayo ee la ansixiyay 4, iyo 6 mashaariicdii waa la ansixinayaa.

Quality management2

Nidaamka maaraynta tayada caalamiga ah ee horumarsan ayaa aasaas adag u dhigay iibka.

Quality management3

Kormeerka tayada ayaa maraya wareegga nolosha oo dhan ee badeecada si loo hubiyo tayada iyo saameynta daaweynta. 

Quality management4

Kooxda Xakamaynta Xirfadleyda waxay taageertaa baahiyaha tayada inta lagu jiro arjiga iyo diiwaangelinta.

MAAMULKA SOO-SAARKA

cpf5
cpf6

Khadka Ku Baakadeeya Dhalada Kuuriya Countec

cpf7
cpf8

Khadka Taakulaynta Caaga Tayada ee Taiwan CVC

cpf9
cpf10

Khadka Baakadaha ee Guddiga CAM ee Talyaaniga

cpf11

Mashiinka Isku-dhafka ah ee Jarmalka

cpf12

Japan Viswill Kiniin Baadhaha

cpf14-1

Qolka Xakamaynta DCS

WADAJIR

Iskaashiga caalamiga ah
International cooperation
Wadashaqeynta gudaha
Domestic cooperation

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