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Selection and justification of starting materials: new Questions and Answers...
DRUG REGULATORY AFFAIRS INTERNATIONAL The ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then...
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CPP 115
(+)-(1S,4S)-4-Amino-3-(difluoromethylene)-1-cyclopentanecarboxylic acid 640897-20-7 CAS PHASE 1 NORTHWESTERN UNIVERSITY .INNOVATORS Sponsor: Catalyst Pharmaceuticals, Inc. CPP-115 free base;...
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Efficient atom and step economic (EASE) synthesis of the “smart drug” Modafinil
Green Chemistry International Efficient atom and step economic (EASE) synthesis of the “smart drug” Modafinil Green Chem., 2017, Advance ArticleDOI: 10.1039/C6GC02623K, Communication Shivam Maurya,...
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MODANAFIL
MODANAFIL Modafinil; 68693-11-8; Provigil; Modiodal; 2-[(diphenylmethyl)sulfinyl]acetamide; Modafinilum [Latin] Molecular Formula: C15H15NO2S Molecular Weight: 273.35 g/mol Patent EP0966962 and Patent...
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Glenmark Launches First and Only Generic Version of Zetia® (Ezetimibe) in the...
Illustration Image Courtesy…..link “We have launched ezetimibe, the first and only generic version of Zetia (Merck) in the United States for the treatment of high...
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FDA approves Eucrisa (crisaborole) for eczema
News Release FDA approves Eucrisa for eczema The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two...
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DNDI-VL-2098
DNDI-VL-2098 CAS 681492-17-1 (R)-2-Methyl-6-nitro-2-(4-trifluoromethoxyphenoxymethyl)-2,3-dihydroimidazo[2,1-b]oxazole Watch this post, will be updated……….. C14 H12 F3 N3 O5, 359.26...
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Citarinostat
Citarinostat Treatment of Hematological Malignancies, Molecular Formula, C24-H26-Cl-N5-O3, Molecular Weight, 467.9544, RN: 1316215-12-9 UNII: 441P620G3P...
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FDA grants accelerated approval to new treatment for advanced ovarian cancer...
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced...
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NEW PATENT, SUGAMMADEX, WO 2016194001
NEW PATENT, SUGAMMADEX, WO 2016194001 WO2016194001, PROCESSES FOR PREPARATION OF SUGAMMADEX AND INTERMEDIATES THEREOF ALAPARTHI, Lakshmi Prasad; (IN). PAL, Palash; (IN). GINJUPALLI, Sadasiva Rao;...
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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 1038915-60-4 CASfree form 1038915-64-8 CAS HYDROCHLORIDE 1613220-15-7 cas TOSYLATE...
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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...
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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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Balsalazide
Balsalazide 80573-04-2; Colazal; Balsalazide Disodium; AC1NSFNR; P80AL8J7ZP; Molecular Formula: C17H15N3O6 Molecular Weight: 357.322 g/mol...
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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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