Ribociclib 1374639-75-4

Tsanangudzo Pfupi

Zita reAPI Indication Innovator Patent Expiry Date (The US)
Ribociclib 1374639-75-4 HR-positive, HER2-negative Andvance ormetastaticbreast Cancers Novartis
Pharmaceuticals
Jun.27, 2028


Product Detail

Product Tags

PRODUCT DETAIL

Tsanangudzo

Ribociclib (LEE01) inonyanya kujeka CDK4/6 inhibitor ine IC50 kukosha kwe10 nM uye 39 nM, zvichiteerana, uye inodarika chiuru-yakapetwa isina simba kurwisa cyclin B/CDK1 yakaoma.

 

In Vitro

Kurapa mapaneru e17 neuroblastoma cell mitsara neRibociclib (LEE011) pane mana-log dose renji (10 kusvika 10,000 nM). Kurapa neRibociclib kunovharisa zvakanyanya substrate adherent kukura maererano nekutonga mu12 ye17 neuroblastoma cell mitsara yakaongororwa (zvinoreva IC50=306±68 nM, tichifunga mitsara yakaoma chete, apo kunzwa kunotsanangurwa seIC50 isingasviki 1.μM. Ribociclib kurapwa kweviri neuroblastoma cell lines (BE2C uye IMR5) nekuratidzira kunzwisiswa kuCDK4/6 inhibition inoguma mukuunganidzwa-kunoenderana nedosi kuunganidzwa kwemasero muG0/G1 chikamu chesero cycle. Uku kusungwa kweG0/G1 kunova kwakakosha paRibociclib concentrations ye100 nM (p=0.007) uye 250 nM (p=0.01), zvichiteerana.

 

CB17 immunodeficient mice dzine BE2C, NB-1643 (MYCN amplified, sensitive in vitro), kana EBC1 (isina-amplified, resistant in vitro) xenografts inorapwa kamwe chete zuva nezuva kwemazuva 21 neRibociclib (LEE011; 200 mg/kg) kana ne kutonga kwemotokari. Iri dosing zano rinotenderwa zvakanaka, sezvo pasina uremu kana zvimwe zviratidzo zvechepfu zvinoonekwa mune chero yemhando yexenograft. Kukura kwebundu kunonyanya kunonoka mukati memazuva makumi maviri nerimwe ekurapwa mumakonzo ane BE2C kana 1643 xenografts (zvose, p <0.0001), kunyange zvazvo kukura kwakatangazve mushure mekurapa.

 

Storage

Upfu

-20°C

3 years

4°C

2 years
In solvent

-80°C

6 mwedzi

-20°C

Mwedzi 1

 

Chimiro chemakemikari

Ribociclib 1374639-75-4

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

HUNHU MANAGEMENT

Hunhu manejimendi1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Hunhu manejimendi2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Hunhu hutongi3

Kutariswa kwemhando yepamusoro kunomhanya kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando uye yekurapa maitiro.

Hunhu manejimendi4

Professional Regulatory Affairs timu inotsigira zvinodiwa zvemhando panguva yekushandisa uye kunyoreswa.

KUTUNGAMIRIRA KWEKUGARA

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Korea Countec Bottled Packaging Line

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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German Fette Compacting Machine

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Japan Viswill Tablet Detector

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DCS Control Room

PARTNER

Kudyidzana kwenyika dzakawanda
Kudyidzana kwenyika dzakawanda
Kushandira pamwe kwemumba
Kushandira pamwe kwemumba

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