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EMA publishes Document on the Validation of analytical Methods
Is it possible to use the results of collaborative trials for analytical methods to prove the laboratory- and product-specific validation of a method? From the perspective of this EMA reflection...
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GMP Matrix – EU GMP Guide – FDA cGMP Guide and ISO 9001 comparison
How can one find a certain GMP requirement in the EU GMP Guide, in the FDA cGMP Guide and in the ISO 9001 without searching for a long time? The Good Practice Guide developed by the ECA has become...
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FDA approves Orbactiv to treat skin infections ….Third new antibacterial drug...
ORITAVANCIN August 6, 2014 Releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm408475.htm The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new...
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Analysis of African plant reveals possible treatment for aging brain
Originally posted on Clinicalnews.org: Salk scientists find that a plant used for centuries by healers of São Tomé e Príncipe holds lessons for modern medicine August 01, 2014 LA JOLLA—For hundreds of...
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AbbVie’s glioblastoma multiforme therapy receives orphan drug designation
ABT-414 is in phase I/II clinical development at AbbVie for the treatment of squamous cell carcinoma. The product is also in early clinical development for the treatment of glioblastoma multiforme. In...
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Female viagra……….UK-414,495 is a drug developed by Pfizer for the treatment...
UK-414,495 Molecular Formula: C16H25N3O3S Molecular Weight: 339.453 UK 414495 CAS 388630-36-2 OF...
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Europe to boost cooperation with international partners on generics
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: 07/08/2014 Europe to boost cooperation with international partners on generics European system to be used as model to facilitate assessment...
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Concept paper on good genomics biomarker practices
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Document details http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/08/WC500170682.pdf Download document Concept...
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World Hepatitis Day – European Medicines Agency uses regulatory tools to...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: 25/07/2014 World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate patient access to innovative medicines...
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The pharmacovigilance system in the European Union (EU)
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The pharmacovigilance system in the European Union (EU) operates with the management and involvement of regulatory authorities in Member...
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Cefuroxime Axetil
Cefuroxime Axetil [6R- [6alpha, 7beta (Z)]] – 3 – [[(Aminocarbonyl) oxy] methyl] -7 – [[2-furanyl (methoxyimino) acetyl] amino] -8-oxo-5-thia-1- azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid 1-...
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EMA grants orphan drug designations to Alnylam’s ALN-AT3 for haemophilia...
EMA grants orphan drug designations to Alnylam’s ALN-AT3 for haemophilia treatment Biopharmaceutical company Alnylam Pharmaceuticals has received orphan drug designations for ALN-AT3 from the...
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Mirati Therapeutics Receives Orphan Designation from U.S. FDA for...
Mocetinostat CAS 726169-73-9; MGCD0103; MGCD-0103; MGCD 0103; N-(2-AMINOPHENYL)-4-([[4-(PYRIDIN-3-YL)PYRIMIDIN-2-YL]AMINO]METHYL)BENZAMIDE...
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New drug discovery: Where are we heading to?
To start with the simplest one is Quantitative structure-activity relationship (QSAR) which is also referred to as 2D-QSAR sometimes. 3D-QSAR involving Comparative Molecular Field Analysis (CoMFA)...
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Cortendo AB: First Patient Enrolled into NormoCort Phase 3 SONICS Trial...
KETOCONAZOLE 2S 4R ALSO 142128-57-2228850-16-6 (tartrate) (-)-cis-1-Acetyl-4-[4-[2(S)-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4(R)-ylmethoxy]phenyl]piperazine 531.431, C26 H28...
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Aesculus … Hippocastani semen/cortex Aesculus hippocastanum L. Horse-Chestnut...
Aesculus Aesculus hippocastanum The genus Aesculus (/ˈɛskjʊləs/[1] or /ˈaɪskjʊləs/) comprises 13–19 species of trees and shrubs native to the temperate Northern Hemisphere, with 6 species native to...
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European Medicines Agency …Clinical trials in human medicines
The European Medicines Agency relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. Although the authorisation of...
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FDA approves first non-invasive DNA screening test for colorectal cancer
August 11, 2014 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM390229.pdf The U.S. Food...
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TERCONAZOLE
Terconazole Systematic (IUPAC) name 1-[4-[ [(2S,4S)-2-(2,4-Dichlorophenyl)-2- (1,2,4-triazol-1-ylmethyl)- 1,3-dioxolan-4-yl]methoxy]phenyl]- 4-propan-2-yl-piperazine Clinical data Trade names Terazol...
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PANTOPRAZOLE
Protonix; Pantoprazolum; Pantoprazol; Pantozol; 102625-70-7; Pantoprazole Sodium; BY-1023; Pantoloc Molecular Formula: C16H15F2N3O4S Molecular Weight: 383.369806 Pantoprazole Systematic (IUPAC)...
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