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EMA issues new Guideline on “Chemistry of Active Substances”
DRUG REGULATORY AFFAIRS INTERNATIONAL The new EMA “Guideline on the chemistry of active substances” represents the current state of the art in regulatory practice and fits into the context of the ICH...
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Niraparib; MK 4827
MK-4827,(S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxaMide Niraparib; MK 4827; MK4827 UNII:HMC2H89N35 Antineoplastic, Poly(ADP-ribose) Polymerase Inhibitors 1038915-60-4 CAS, free form...
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CENTANAFADINE
Centanafadine; UNII-D2A6T4UH9C; EB-1020 free base; D2A6T4UH9C; 924012-43-1 CTN SR; EB-1020; EB-1020 SR WO 2007016155 Molecular Formula: C15H15N Molecular Weight: 209.292 g/mol Phase II...
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GMP’s for Early Stage Development of new Drug substances and products
DRUG REGULATORY AFFAIRS INTERNATIONAL GMP’s for Early Stage Development of New Drug substances and products The question of how Good Manufacturing Practice (GMP) guidelines should be applied during...
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Calcifediol, カルシフェジオール
Calcifediol カルシフェジオール Ro 8-8892 U 32070E (3b,5Z,7E)-9,10-Secocholesta-5,7,10(19)-triene-3,25-diol (3S,5Z,7E,20R)-9,10-Secocholesta-5,7,10-trien-3,25-diol [German] [ACD/IUPAC Name]...
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SL65.0102-10
CAS 186348-69-6 1,4-Benzodioxin-5-carboxamide, 8-amino-7-chloro-N-(1,4-diazabicyclo[2.2.2]oct-2-ylmethyl)-2,3-dihydro-, (-)- MW, 352.82, C16 H21 Cl N4 O3 US5663173 (A) – N-[(1,4-diazabicyclo[2.2.2]...
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Towards automation of chemical process route selection based on data mining
ORGANIC CHEMISTRY SELECT A methodology for chemical routes development and evaluation on the basis of data-mining is presented. A section of the Reaxys database was converted into a network, which was...
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Amtolmetin guacil, амтолметин гуацил , أمتولمتين غواسيل , 呱氨托美丁
Amtolmetin guacil, ST-679, MED-15, Eufans CAS 87344-06-7 UNII: 323A00CRO9, Molecular Formula, C24-H24-N2-O5, Molecular Weight, 420.463, 2-Methoxyphenyl...
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FDA publishes Final Guideline on GMP for Combination Products
DRUG REGULATORY AFFAIRS INTERNATIONAL In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the...
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Thailand Drug regulatory Update, Take a peep
DRUG REGULATORY AFFAIRS INTERNATIONAL http://www.fda.moph.go.th/eng/index.stm [PDF]Regulatory Requirement for the Approval of generic Drug in Thailand …...
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EMA publishes Q&A on Health Based Exposure Limits – Does the 1/1000 dose...
DRUG REGULATORY AFFAIRS INTERNATIONAL In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of...
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Brigatinib, Бригатиниб, بريغاتينيب , 布格替尼 ,
Brigatinib, AP26113 Molecular Formula: C29H39ClN7O2P Molecular Weight: 584.102 g/mol CAS 1197953-54-0 2,4-Pyrimidinediamine,...
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FOTAGLIPTIN
FOTAGLIPTIN CAS 1312954-58-7 342.37, C17 H19 F N6 O Benzonitrile, 2-[[3-[(3R)-3-amino-1-piperidinyl]-6-methyl-5-oxo-1,2,4-triazin-4(5H)-yl]methyl]-4-fluoro-...
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Nonsteroidal antiandrogens,...
C12 H17 Br N2 O3, 317.18 Butanamide, N-(2-bromo-6-methoxy-4-pyridinyl)-2-hydroxy-2,3-dimethyl-, (2S)- (S)-N-(2-bromo-6-methoxypyridin-4-yl)-2-hydroxy-2,4-dimethylpentanamide...
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Telcagepant Revisited
Telcagepant, MK-0974 Molecular FormulaC26H27F5N6O3 Average mass566.523 Da 1-piperidinecarboxamide,...
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BMS-960
BMS-960 PRECLINICAL (S)-1-((S)-2-Hydroxy-2-(4-(5-(3-phenyl-4-(trifluoromethyl)isoxazol-5-yl)-1,2,4-oxadiazol-3-yl)phenyl)ethyl)piperidine-3-carboxylic Acid 3-Piperidinecarboxylic acid,...
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Plinabulin
Plinabulin Molecular FormulaC19H20N4O2 Average mass336.388 Da (3Z,6Z)-3-Benzylidène-6-{[4-(2-méthyl-2-propanyl)-1H-imidazol-5-yl]méthylène}-2,5-pipérazinedione 2,5-Piperazinedione,...
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Hoshinolactam, A new antitrypanosomal lactam
Tropical diseases caused by parasitic protozoa are a threat to human health, mainly in developing countries. Trypanosomiasis (Chagas disease and sleeping sickness) and leishmaniasis, inter alia, are...
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AMG-3969
AMG-3969 M.Wt: 522.46 Cas : 1361224-53-4 , MF: C21H20F6N4O3S WO 2012027261 PRODUCT PATENT Inventors Kate Ashton, Michael David Bartberger, Yunxin Bo, Marian C. Bryan, Michael Croghan, Christopher...
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MK 0633, SETILEUTON
MK 0633, SETILEUTON (-)-enantiomer 910656-27-8 CAS free form MW 463.3817, C22 H17 F4 N3 O4 FREE FORM Tosylate cas 1137737-87-1 2H-1-Benzopyran-2-one,...
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