Dabigatran Etexilate Mesylate

Description:

API Nomen Indicium Specification US DMF EU DMF CEP
Dabigatran Etexilate Mesylate Anticoagulant In-Domus      


Product Detail

Product Tags

Product SINGULA

Descriptio

Dabigatran etexilatum mesylatum (BIBR 1048MS) est viva voce prodrug Dabigatran.Dabigatran etexilatum mesylatum habet effectus anticoagulantes et adhibetur pro prophylaxi venousthromboembolismi et plaga propter fibrillationem atrialem.

Background

Description: IC50 Value: 4.5nM (Ki);10nM(Thrombin-inducta aggregatio platelet) [1] Dabigatran est convertibilis et selectivus, directus thrombin inhibitor (DTI) progressionem clinicam sustinens sicut viva voce prodrug, dabigatran etexilata.in vitro: Dabigatran selective et reversibly inhibuit thrombin humanum (Ki: 4.5 nM) necnon aggregatio thrombin-inducta in platelet (IC(50): 10 nM), cum nullum effectum inhibitorium praebens in aliis agentibus platelet-stimulantibus. Thrombin generatio in platelet. - pauper plasma (PPP), mensuratum ut potentiale thrombin endogenous (ETP) inhibitum concentrationis-dependens (IC(50): 0.56 microM).Dabigatran demonstratum effectibus anticoagulantibus concentratione-dependens in variis speciebus in vitro, duplicando tempus partiale thromboplastin (aPTT), tempus prothrombin (PT) et ecarin concretionis temporis (ECT) in humanis PPP ad collectiones 0.23, 0.83 et 0.18 microM, respective [. 1].in vivo: Dabigatran aPTT dosis dependenter post administrationem intravenosam in muribus (0.3, 1 et 3 mg/kg) protraxit et simias rhesus (0.15, 0.3 et 0.6 mg/kg).Dose- et temporis dependens anticoagulantes effectus observati sunt cum dabigatran etexilate viva voce ad mures conscios (X, 20 et 50 mg/kg) vel ad simias rhesus (1, 2.5 vel 5 mg/kg), effectibus maximis inter 30 et 120 observatis. min post administrationem respective [1].Aegroti cum dabigatran etexilate tractaverunt pauciores ictus ischemici (3.74 dabigatran etexilate vs 3.97 warfarin) et pauciores mixti haemorrhagiae intracraniales et haemorrhagiae ictus (0.43 dabigatran etexilate vs 0.99 warfarin) per 100 annos passi [2].Cusci iudicii: Aestimatio Pharmacokineticorum et Pharmacodynamicorum Oral Dabigatran Etexilate in Hemodialysis aegros.Phase1

Repono

Pulvis

-20°C

III annos
 

4°C

Annis II
In solvendo

-80°C

VI menses
 

-20°C

I mensis

Orci iudicio

NCT Number Sponsor Conditio Satus Date

Phase

NCT02170792 Boehringer Ingelheim Sanus Februarii 2001

Phase 1

NCT02170974 Boehringer Ingelheim Sanus Iulii 2004

Phase 1

NCT02170831 Boehringer Ingelheim Sanus Maii MCMXCIX

Phase 1

NCT02170805 Boehringer Ingelheim Sanus Aprilis 2001

Phase 1

NCT02170610 Boehringer Ingelheim Sanus Martii 2002

Phase 1

NCT02170909 Boehringer Ingelheim Sanus Decembris 2004

Phase 1

NCT02171000 Boehringer Ingelheim Sanus Aprilis 2005

Phase 1

NCT02170844 Boehringer Ingelheim Sanus Iunii 2004

Phase 1

NCT02170584 Boehringer Ingelheim Sanus Ianuarii 2001

Phase 1

NCT02170935 Boehringer Ingelheim Venarum thromboembolismus Aprilis MMII

Phase 2

NCT02170636 Boehringer Ingelheim Sanus Ianuarii 2002

Phase 1

NCT02170766 Boehringer Ingelheim Sanus Octobris 2000

Phase 1

NCT02171442 Boehringer Ingelheim Sanus Aprilis MMII

Phase 1

NCT02170896 Boehringer Ingelheim Sanus Octobris 2001

Phase 1

NCT02173730 Boehringer Ingelheim Sanus November 2002

Phase 1

NCT02170623 Boehringer Ingelheim Sanus Februarii anno MMII

Phase 1

NCT0217016 Boehringer Ingelheim Sanus Novembris 1998

Phase 1

NCT02170597 Boehringer Ingelheim Sanus Augusti 2003

Phase 1

NCT01225822 Boehringer Ingelheim Venarum thromboembolismus November 2002

Phase 2

NCT02170701 Boehringer Ingelheim Venarum thromboembolismus Octobris 2000

Phase 2

NCT02170740 Boehringer Ingelheim Sanus Novembris 1999

Phase 1

NCT02170922 Boehringer Ingelheim Sanus Iulii 1999

Phase 1

Chemical structure

Dabigatran Etexilate Mesylate

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

QUALITY MANAGEMENT

Quality management1

Rogatio18Qualitas Constantia Aestimatio inceptis quae probaverunt4, et6incepta approbantes.

Quality management2

Provectus qualitas internationalis administrandi ratio solidum fundamentum venditio posuit.

Quality management3

Qualitas vigilantia percurrit totum vitae cyclum producti, ut qualitatem et therapeuticum effectum curet.

Quality management4

Negotiis professionalibus regularibus turmas sustinet qualitatem postulatorum in applicatione et adnotatione.

PROLATIO MAGISTERIUM

cpf5
cpf6

Korea Countec Bottled Packaging linea

cpf7
cpf8

Taiwan CVC Bottled Packaging Line

cpf9
cpf10

Italia CAM Board Packaging Line

cpf11

German Fette Compacting Machine

cpf12

Iaponia Viswill Traba Detector

cpf14-1

DCS Control Room

SOCIUS

Cooperatio internationalis
International cooperation
Cooperatio domestica
Domestic cooperation

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