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Wockhardt, WO 2007023507,...
Cas 928156-95-0, Acetamide, N-[[(5S)-3-[3,5-difluoro-4-[4-(2H-tetrazol-2-yl)-1-piperidinyl]phenyl]-2-oxo-5-oxazolidinyl]methyl]- C18H21F2N7O3 Molecular Weight: 421.401246...
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TR 700, TR 701FA, Tedizolid phosphate
“TR-700” 5R)-3-{3-Fluoro-4-[6-(2-methyl-2H-1,2,3,4-tetrazol-5-yl)-pyridin-3-yl]-phenyl}-5-hydroxymethyl-1,3-oxazolidin-2-one Trius Therapeutics, Inc. US Patent Publication No. 20070155798, which is...
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Genotoxic impurities: the new ICH M7 addendum to calculation of...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes The draft for a guideline ICH M7(R1)...
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New FDA Requirements for the Development of Herbal Medicinal Products
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The previous FDA guideline for herbal medicinal products from 2004 is supposed to be replaced by a new version. In August 2015, the FDA has...
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Efficacy and Safety of Olive in the Management of Hyperglycemia
Postprandial hyperglycemia indicates the abnormality in glucose turnover leading to the onset of type 2 diabetes. Therefore, correction of postprandial hyperglycemia is crucial in the early stage of...
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Defibrotide
Defibrotide is the sodium salt of a mixture of single-stranded oligodeoxyribonucleotides derived from porcine mucosal DNA. It has been shown to have antithrombotic, anti-inflammatory and anti-ischemic...
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SILDENAFIL
SILDENAFIL The chemical name of sildenafil is 5-[2-ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1- methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one and its formula is C22H30N6O4S. The...
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Merestinib
1206799-15-6[RN] 3-Pyridinecarboxamide, N-[3-fluoro-4-[[1-methyl-6-(1H-pyrazol-4-yl)-1H-indazol-5-yl]oxy]phenyl]-1-(4-fluorophenyl)-1,2-dihydro-6-methyl-2-oxo-[ACD/Index Name] LY2801653 LY-2801653...
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Acceptability of Draft Labeling to Support ANDA Approval Guidance for Industry
Acceptability of Draft Labeling to Support ANDA Approval Guidance for Industry INTRODUCTION This guidance provides recommendations and information related to the submission of proposed labeling with...
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Synthesis of a fluorinated Ezetimibe analogue
Synthesis of a fluorinated Ezetimibe analogue using radical allylation of [small alpha]-bromo-[small alpha]-fluoro-[small beta]-lactam New J. Chem., 2015, Advance Article DOI: 10.1039/C5NJ01969A,...
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Altiratinib
Altiratinib DCC-2701; DP-5164 CAS :1345847-93-9 N-[4-({2-[(cyclopropylcarbonyl)amino]pyridin-4-yl}oxy)-2,5-difluorophenyl]-N-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide...
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Sparsentan, PS433540, RE-021
Sparsentan(PS433540,RE-021) C32H40N4O5S Average mass592.749 4′-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-N-(4,5-dimethylisoxazol-3-yl)-2′-(ethoxymethyl)-[1,1′-biphenyl]-2-sulfonamide...
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BMS-248360, A NEW SARTAN ON HORIZON
2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-[(3,3-dimethyl-2-oxopyrrolidin-1-yl)methyl]phenyl]-N-(3,4-dimethyl-1,2-oxazol-5-yl)benzenesulfonamide...
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Ravidasvir, PPI-668, BI 238630
Ravidasvir dihydrochloride C42H50N8O6.2(HCl), 835.83 CAS 1303533-81-4 Phase II/IIIHepatitis C Ravidasvir PPI-668 free base; BI 238630; CAS:1242087-93-9 C42H50N8O6, 762.38 Chemical Name:methyl...
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Daprodustat, GSK1278863
Daprodustat, GSK1278863 960539-70-2 GSK1278863; GSK 1278863; GSK-1278863; Daprodustat C19H27N3O6 Exact Mass: 393.18999 (1,3-dicyclohexyl-2,4,6-trioxohexahydropyrimidine-5-carbonyl)glycine...
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Pharma Regulations for Generic Drug Products in India and US: Case Studies...
Dr. Suryakanta Swain Introduction The Indian pharmaceutical industry has come a long way from being non-existent before independence to a prominent provider of medicines and health care products in...
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Cutting Edge of Pharmaceutical Nanotechnology
Nanoscience is the engineering of functional systems at the molecular scale. This covers both current work and concepts that are more advanced. In its original sense, nanotechnology refers to the...
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Israeli scientists turn Nano science fiction into fact
Find out how Israeli scientists are manipulating the tiniest parts of matter to make life better for millions. Think of a tiny robot transporting drugs to a cancer cell in your body. An artificial...
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The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles...
The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients The occurrence of foreign particles in the manufacture of active...
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Finally published: new Annex 16 on QP Certification and Batch Release
Finally published: new Annex 16 on QP Certification and Batch Release The European Commission finally has published the new EU-GMP Guideline Annex 16 “Certification by a Qualified Person and Batch...
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