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How does a company demonstrate the implementation of PQS in accordance with ICH?

DRUG REGULATORY AFFAIRS INTERNATIONAL ICH Q10 was published in its final version already in 2008. However, today many companies still have problems to understand how to implement ICH Q10...

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WAY-315193

WAY-315193 7-Fluoro-1-[(1S,2R)-1-(3-fluorophenyl)-2-hydroxy-3-(methylamino)propyl]-3,3-dimethylindolin-2-one Hydrochloride Drugs that possess norepinephrine reuptake inhibition, either selectively or...

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Cetilistat, セチリスタット

Cetilistat, セチリスタット Molecular FormulaC25H39NO3 Average mass401.582 Da CAS 282526-98-1 2-(Hexadecyloxy)-6-methyl-4H-3,1-benzoxazin-4-one 282526-98-1 [RN] 2-Hexadecyloxy-6-methyl-4H-3,1-benzoxazin-4-one...

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BMS-442608

BMS-442608 8-Azaspiro(4.5)decane-7,9-dione, 6-hydroxy-8-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-, (6R)- (6R)-6-Hydroxy-8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione...

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Onions contain a powerful cancer fighting compound — ClinicalNews.Org

Onions contain a powerful cancer fighting compound Onions contain a powerful cancer fighting compound We review the study” Anti-cancer effects found in natural compound derived from onions ” This...

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BMS-741672

BMS-741672 N-((1R,2S,5R)-5-(Isopropyl(methyl)amino)-2-((S)-2-oxo-3-(6-(trifluoromethyl)quinazolin-4-ylamino)pyrrolidin-1-yl)cyclohexyl)acetamide BMS-741672...

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Counterfeit of medicines causes 37,000 job losses in EU Pharma Industry

DRUG REGULATORY AFFAIRS INTERNATIONAL Counterfeit medicine is an increasing problem for public health and economy. This is no longer a problem of certain regions such as Asia and Africa. It has now...

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The impact of the FDA Combination Products Guidance on Nasal and Oral...

DRUG REGULATORY AFFAIRS INTERNATIONAL The FDA draft guidance for combination products has a substantial impact on the development of Oral Inhalation and Nasal Drug Products (OINDPs) as it requires...

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FDA presentation at the ECA Conference Particles in Parenterals

DRUG REGULATORY AFFAIRS INTERNATIONAL At the Particles in Parenterals Conference Dr Stephen Langille from the US FDA gave a talk on the FDA’s current thinking with regard to the visual inspection of...

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Critical Impurities in Pharmaceutical Water

DRUG REGULATORY AFFAIRS INTERNATIONAL The quality of the source water used to produce pharmaceutical water plays an important role for both the design of the treatment and the validation of the water...

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Design and synthesis of indoline thiohydantoin derivatives based on...

4-(6-chloro-1-oxo-3-thioxo-9,9a-dihydro-1H-imidazo[1,5-a]indol-2(3H)-yl)-2-(trifluoromethyl)-benzonitrile WILL BE UPDATED……… Prostate cancer, one of the most malignant tumors worldwide, is the second...

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A Concise and Highly Efficient Synthesis of Praziquantel as an Anthelmintic Drug

PAPER HETEROCYCLES An International Journal for Reviews and Communications in Heterocyclic Chemistry Web Edition ISSN: 1881-0942 Published online: 11th October, 2016 Paper | Regular issue | Prepress...

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QbD: Controlling CQA of an API

DRUG REGULATORY AFFAIRS INTERNATIONAL The importance of Quality by Design (QbD) is being realized gradually, as it is gaining popularity among the generic companies. However, the major hurdle faced by...

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QbD Sitagliptin

DRUG REGULATORY AFFAIRS INTERNATIONAL Application of On-Line NIR for Process Control during the Manufacture of Sitagliptin George Zhou*, Shane Grosser, Lei Sun, Gabriel Graffius, Ganeshwar Prasad,...

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BOSENTAN PRECURSOR

N,N′-(6,6′-(2,2-Dimethyl-1,3-dioxolane-4,5-diyl)bis- (methylene)bis(oxy)bis(5-(2-methoxy phenoxy)-2,2′-bipyrimidine-6,4-diyl))bis(4-tert-butylbenzenesulfonamide) Mp: 72−74 °C. 1 H NMR (400 MHz,...

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BMS-599793

BMS-599793 (DS003, BMS-599793) Molecular Formula: C27H22N6O3 Molecular Weight: 478.512 g/mol...

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Solifenacin, солифенацин , سوليفيناسين , 索利那新 ,

SOLIFENACIN, YM-905 MF C23H26O2, a molecular weigt  362.4647 CAS 242478-37-1 солифенацин [Russian] سوليفيناسين [Arabic] 索利那新 [Chinese] 242478-37-1 (Solifenacin ) 242478-38-2 (Solifenacin Succinate)...

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Rush , few seats, ACS INDUSTRY SYMPOSIUM RECENT ADVANCES IN DRUG DEVELOPMENT...

ACS INDUSTRY SYMPOSIUM RECENT ADVANCES IN DRUG DEVELOPMENT IN PARTNERSHIP WITH DR. REDDY’S LABORATORIES HYDERABAD, INDIA 11-12 NOVEMBER 2016 click        http://acssymposium.org.in/ for...

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PF 610355 Revisited

  PF-610355 Molecular Formula C34H39N3O6S Average mass 617.755 Da PF 610655, PF-00610355; PF-610,355...

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Asymmetric synthesis of (S)-phenylacetylcarbinol – closing a gap in C–C bond...

Green Chemistry International Green Chem., 2017, Advance ArticleDOI: 10.1039/C6GC01803C, Communication Torsten Sehl, Saskia Bock, Lisa Marx, Zaira Maugeri, Lydia Walter, Robert Westphal, Constantin...

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