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What are the GMP Responsibilities of the Marketing Authorisation Holders?
DRUG REGULATORY AFFAIRS INTERNATIONAL The European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH)....
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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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ANDA Submissions – Prior Approval Supplements Under GDUFA, FDA Guidance document
DRUG REGULATORY AFFAIRS INTERNATIONAL ANDA Submissions – Prior Approval Supplements Under GDUFA, FDA Guidance document, oct 2016, Generics The presentation will load below //////ANDA Submissions,...
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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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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...
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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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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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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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Algae-mediated biosynthesis of inorganic nanomaterials as a promising route...
Green Chemistry International Green Chem., 2016, Advance ArticleDOI: 10.1039/C6GC02346K, Critical Review Si Amar Dahoumane, Mourad Mechouet, Kushlani Wijesekera, Carlos D. M. Filipe, Clemence Sicard,...
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BRD 2879
BRD2879 BRD-K56962879-001-01-5 CAS 1304750-47-7 Chemical Formula: C30H38FN3O5S Molecular Weight: 571.7084...
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