Clik here to view.
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...
View ArticleClik here to view.
Niraparib; MK 4827
MK-4827,(S)-2-(4-(piperidin-3-yl)phenyl)-2H-indazole-7-carboxaMide Niraparib; MK 4827; MK4827 UNII:HMC2H89N35 1038915-60-4 CASfree form 1038915-64-8 CAS HYDROCHLORIDE 1613220-15-7 cas TOSYLATE...
View ArticleClik here to view.
FDA approves first drug Spinraza (nusinersen), for spinal muscular atrophy
FDA approves first drug for spinal muscular atrophy New therapy addresses unmet medical need for rare disease The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug...
View ArticleClik here to view.
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...
View ArticleClik here to view.
Balsalazide
Balsalazide 80573-04-2; Colazal; Balsalazide Disodium; AC1NSFNR; P80AL8J7ZP; Molecular Formula: C17H15N3O6 Molecular Weight: 357.322 g/mol...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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]...
View ArticleClik here to view.
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]...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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 …...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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,...
View ArticleClik here to view.
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-...
View ArticleClik here to view.
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...
View ArticleClik here to view.
Telcagepant Revisited
Telcagepant, MK-0974 Molecular FormulaC26H27F5N6O3 Average mass566.523 Da 1-piperidinecarboxamide,...
View ArticleClik here to view.
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,...
View ArticleClik here to view.
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,...
View ArticleClik here to view.
Article 0
Pridopidine Molecular Formula C15H23NO2S Average mass 281.414 Da 346688-38-8 CAS FREE FORM 882737-42-0 (hydrochloride) 1440284-30-9 HBr 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidin 4- (3...
View Article