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Handling of OOS Results in Europe
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: FDA’s Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the...
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Best practice paper on visual inspection to be published in September 2014
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The ECA working group on visual inspection, which was founded this year, is going to publish its first document during the ECA event...
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Aripiprazole lauroxil ……….Alkermes submits new drug application
Aripiprazole 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]- 3,4-dihydro-2(1H)-quinolinone. END AUG 2014 The US Food and Drug Administration (FDA) has received a new drug application (NDA) from...
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New cocrystals of ezetimibe with L-proline and imidazole
New cocrystals of ezetimibe with L-proline and imidazole CrystEngComm, 2014, Advance ArticleDOI: 10.1039/C4CE01127A, Paper Manishkumar R. Shimpi, Scott L. Childs, Dan Bostrom, Sitaram P. Velaga...
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Structural characterization of form I of anhydrous rifampicin
Structural characterization of form I of anhydrous rifampicin CrystEngComm, 2014, 16,8555-8562DOI: 10.1039/C4CE01157K, Paper Amanda Laura Ibiapino, Rafael Cardoso Seiceira, Altivo Pitaluga, Antonio...
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Cocrystals of telmisartan: characterization, structure elucidation, in vivo...
Cocrystals of telmisartan: characterization, structure elucidation, in vivo and toxicity studies CrystEngComm, 2014, 16,8375-8389DOI: 10.1039/C4CE00797B, Paper Renu Chadha, Swati Bhandari, Jamshed...
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Clopidogrel
Clopidogrel READ AT http://drugsynthesisint.blogspot.in/2014/08/clopidogrel.htmlFiled under: GENERIC DRUG Tagged: Clopidogrel
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Fighting prostate cancer with a tomato-rich diet
Originally posted on Clinicalnews.org: PUBLIC RELEASE DATE: 27-Aug-2014 Men who eat over 10 portions a week of tomatoes have an 18 per cent lower risk of developing prostate cancer, new research...
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Idarubicin hydrochloride
Idarubicin hydrochloride NSC-256439, IMI-30, DMDR, Idamycin, Zavedos Idarubicin /ˌaɪdəˈruːbɨsɪn/ or 4-demethoxydaunorubicin is an anthracycline antileukemic drug. It inserts itself into DNA and...
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Idoxuridine
Idoxuridine, NSC-39661, IdUrd, IDUR, IDU, IUDR, Herpid Idoxuridine is an anti-herpesvirus antiviral drug. It is a nucleoside analogue, a modified form of deoxyuridine, similar enough to be...
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Aldoxorubicin…CytRx is pouring money into R&D of cancer-fighting drugs
Aldoxorubicin, DOXO-EMCH...
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Telmapitant……Tachykinin NK1 Antagonists
Telmapitant TELMAPITANT; Telmapitant (USAN); Telmapitant [USAN]; 552292-58-7; HJ5FE4153B; D10391...
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USFDA grants Qualified Infectious Disease Product status to two Wockhardt...
31 Aug, 2014, NEW DELHI: Drug maker WockhardtBSE -1.83 % today said that two of its anti-infective drugs have received Qualified Infectious Disease Product (QIDP) status from the US health...
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Levonadifloxacin arginine salt, WCK 771
STEREOCENTERS SHOWN Levonadifloxacin arginine salt, WCK 771 S-(−)-9-Fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic Acid l-Arginine Salt...
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AMBROXOL
Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. It is the active ingredient of Mucosolvan, Mucobrox, Mucol, Lasolvan,...
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Idasanutlin (RG-7388)…….for the oral treatment of cancer, including solid...
Idasanutlin(RG-7388) cas 1229705-06-9 4-{ [(2R,3S,4R,5S)-4-(4-Chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2- dimethyl-prop yl)-pyrrolidine-2-carbonyl] -amino...
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Bacteria responsible for gum disease facilitates development and progression...
Originally posted on Clinicalnews.org: 10 AUG 2012 Gum disease 4 times as common in rheumatoid arthritis patients Might be potential trigger and/or help sustain inflammation suggest researchers Gum...
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Cipla introduces Serroflo for respiratory treatment in Germany and Sweden
India-based Cipla has introduced Serroflo (salmeterol/fluticasone MDI) in Germany and Sweden to treat patients suffering from asthma. Serroflo is expected to improve the affordability of fixed...
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The Procedure for Manufacturing Drugs in Mie Prefecture, Japan.
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The Procedure for Manufacturing Drugs in Mie Prefecture, Japan. The following details the necessary procedure for the commencement of...
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CLINICAL TRIALS………… JAPAN
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Clinical trials Clinical trials, also known as clinical studies, are scientific studies of drugs, medical devices or other treatments in...
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