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ICH Q3D Implementation Working Group (IWG)—Training Modules
DRUG REGULATORY AFFAIRS INTERNATIONAL ICH Q3D Implementation Working Group (IWG)—Training Modules ICH Q3D is a complex guideline. The overall requirement in terms of control is clear—there are defined...
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FDA´s new policy regarding grouping of supplements for CMC changes
DRUG REGULATORY AFFAIRS INTERNATIONAL The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and...
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EMA publishes Q A on data required for sterilized primary packaging materials...
DRUG REGULATORY AFFAIRS INTERNATIONAL The European Medicines Agency, EMA, recently published questions and answers on what data is required for sterilisation processes of primary packaging materials...
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ICH M7
DRUG REGULATORY AFFAIRS INTERNATIONAL ICH M7 Although relatively quiet in terms of any specific regulatory activities, the last 6 months have seen a plethora of publications that are associated with...
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PDE4 inhibitor , Sumitomo Dainippon Pharma Company
2-[2-Methyl-1-(tetrahydro-2H-pyran-4-yl)-1H-benzimidazol-5-yl]-1,3-benzoxazole Hemifumarate Sumitomo Dainippon Pharma Company, CAS FREE FORM 1256966-65-0 Benzoxazole,...
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Higenamine Hydrochloride
Higenamine Hydrochloride 6,7-Isoquinolinediol, 1,2,3,4-tetrahydro-1-[(4-hydroxyphenyl)methyl]-, hydrochloride (9CI) 6,7-Isoquinolinediol, 1,2,3,4-tetrahydro-1-[(4-hydroxyphenyl)methyl]-,...
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EU GMP Annex 1 Revision 2016 – what does the pharmaceutical industry expect?
DRUG REGULATORY AFFAIRS INTERNATIONAL Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at...
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WHO issues revised Guideline on HVAC Systems
DRUG REGULATORY AFFAIRS INTERNATIONAL The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of...
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[18F]AMG 580
[18F]AMG 580 CAS 1879904-74-1 MF C26 H24 F N5 O3 NOTE………CAS OF AMG 580 IS 1227067-71-1, WITHOUT 18F AMG 580...
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[F-18](2S,4S)-4-(3-Fluoropropyl)glutamine
[F-18](2S,4S)-4-(3-Fluoropropyl)glutamine CAS 1196963-79-7 MF C8 H15 F N2 O3 Heptanoic acid, 2-amino-4-(aminocarbonyl)-7-(fluoro-18F)-, (2S,4S)- [18F](2S,4S)-4-FPGln...
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Дапипразол Dapiprazole
Dapiprazole CAS 72822-12-9 HCL SALT 72822-13-0 5,6,7,8-Tetrahydro-3-(2-(4-(O-tolyl)-1-piperazinyl)ethyl)-S-triazolo(4,3-a)pyridine Dapiprazole (Rev-Eyes) is an alpha blocker. It is used to reverse...
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Results of a Survey on ICH Q3D “Elemental Impurities”
DRUG REGULATORY AFFAIRS INTERNATIONAL For most companies manufacturing APIs and pharmaceutical products, the implementation of ICH Q3D has a serious impact – as shown in a survey recently carried out...
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EDQM’s new Guideline on Electronic Submissions for CEP Applications
DRUG REGULATORY AFFAIRS INTERNATIONAL EDQM’s new Guideline on Electronic Submissions for CEP Applications As of today (June, 1st 2016), the EDQM doesn’t accept any CEP application in paper format....
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Ladostigil
Ladostigil, TV-3,326 (N-propargyl-(3R) aminoindan-5yl)-ethyl methyl carbamate (3R)-3-(Prop-2-ynylamino)indan-5-yl ethyl(methyl)carbamate; R-CPAI Carbamic acid, ethylmethyl-,...
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Obeticholic acid
Obeticholic acid Obeticholic acid; 6-ECDCA; INT-747; 459789-99-2; 6-Ethylchenodeoxycholic acid; 6alpha-Ethyl-chenodeoxycholic acid;...
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AM 2394
AM 2394 1-(6′-(2-hydroxy-2-methylpropoxy)-4-((5-methylpyridin-3-yl)oxy)-[3,3′-bipyridin]-6-yl)-3-methylurea Urea,...
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3,5-Dibromo-N-(4,6-difluorobenzo[d]thiazol-2-yl)thiophene-2-carboxamide...
3,5-Dibromo-N-(4,6-difluorobenzo[d]thiazol-2-yl)thiophene-2-carboxamide New and novel anti-norovirus agents There is an urgent need for structurally novel anti-norovirus agents. In this study, we...
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WHO defines Requirements on Zones E and F
DRUG REGULATORY AFFAIRS INTERNATIONAL In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It...
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ND 630, NDI 010976
ND 630, NDI 010976, ND-630, NDI-010976 1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4-yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic...
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Perspectives on Anti-Glycan Antibodies Gleaned from Development of a...
Antibodies are used extensively for a wide range of basic research and clinical applications. While an abundant and diverse collection of antibodies to protein antigens have been developed, good...
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