Clik here to view.
Buthionine Sulphoximine
Buthionine Sulphoximine NDA Filed in china A gamma-glutamylcysteine synthetase inhibitor potentially for the treatment of solid tumors. NSC-326231; BSO CAS No. 5072-26-4 BUTHIONINE SULFOXIMINE;...
View ArticleClik here to view.
EMA’s new Draft Guideline on the Sterilisation of Medicinal Products, APIs,...
DRUG REGULATORY AFFAIRS INTERNATIONAL For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA...
View ArticleClik here to view.
USP publishes draft of a new general chapter for plastic components used in...
DRUG REGULATORY AFFAIRS INTERNATIONAL In the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters – Packaging and Distribution Expert Committee proposes a new general chapter...
View ArticleClik here to view.
APIs from Legitimate and Reliable Sources
DRUG REGULATORY AFFAIRS INTERNATIONAL APIs from Legitimate and Reliable Sources 1. Introduction Counterfeit and sub-standard APIs are increasingly present. Not only are they a fact of non-compliance...
View ArticleClik here to view.
BMS-520, a Potent and Selective Isoxazole-Containing S1P1 Receptor Agonist
BMS-520 CAS: 1236188-38-7 MF: C23H17F3N4O4 MW: 470.1202 Synonym: BMS-520; BMS 520; BMS520. INNOVATOR Bristol-Myers Squibb Company INVENTORS Scott Hunter Watterson, Alaric J. Dyckman,William J. Pitts,...
View ArticleClik here to view.
7th Annual Clinical Trials Summit 2016, 24th May 2016, The Lalit Hotel,...
“7th Annual Clinical Trials Summit 2016” “A critical guide for successfully conducting clinical...
View ArticleClik here to view.
CDRI 830
CDRI 830 CDRI S006-830 N-[2-[4-[(4-methoxyphenyl)-thiophen-2-ylmethyl]phenoxy]ethyl]-N-propan-2-ylpropan-2-amine Molecular Formula: C26H33NO2S Molecular Weight: 423.61072 g/mol CDRI-830 of thiophene...
View ArticleClik here to view.
Letermovir, AIC 246
Letermovir, MK 8828, AIC 246 2-[(4S)-8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4H-quinazolin-4-yl]acetic acid CAS 917389-32-3 Letermovir; UNII-1H09Y5WO1F;...
View ArticleClik here to view.
ICH M8 “Specification for Submission Formats for eCTD”
DRUG REGULATORY AFFAIRS INTERNATIONAL This additional specification describes the way files should be constructed for inclusion in the eCTD. Key Points: It is not necessary to use a product from Adobe...
View ArticleClik here to view.
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...
View ArticleClik here to view.
PDE4 Inhibitors, Boehringer Ingelheim Pharmaceuticals
R CONF SHOWN BI ? (R)-2-(4-(4-Chlorophenoxy)piperidin-1-yl)-4-((tetrahydro-2H-pyran-4-yl)amino)-6,7-dihydrothieno[3,2-d]pyrimidine 5-Oxide C22 H27 Cl N4 O3 S, 462.99 CAS 1910076-27-5...
View ArticleClik here to view.
MK 8718
MK 8718 Cas 1582729-24-5 (free base); 1582732-29-3 (HCl). MF: C30H30ClF6N5O4 MW: 673.1891 INNOVATOR Merck Sharp & Dohme Corp., Merck Canada Inc....
View ArticleClik here to view.
MK-7145
MK-7145, cas 1255204-84-2 1(3H)-Isobenzofuranone, 5,5′-(1,4-piperazinediylbis((1R)-1-hydroxy-2,1-ethanediyl))bis(4-methyl- MF C26 H30 N2 O6, Molecular Weight 466.53 1(3H)-Isobenzofuranone,...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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...
View ArticleClik here to view.
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,...
View ArticleClik here to view.
Quisapride Hydrochloride
Quisapride Hydrochloride (R) – quinuclidine-3-5 – ((S) -2 – (( 4 – amino-5-chloro-2-ethoxy benzoylamino) methyl) morpholino) hexanoate IND Filed china A 5-HT4 agonist potentially for the treatment of...
View ArticleClik here to view.
DSM 265 a promising Antimalarial
DSM265 DSM-265; PfSPZ 2-(1,1-difluoroethyl)-5-methyl-N-(4-(pentafluoro-l6-sulfanyl)phenyl)-[1,2,4]triazolo[1,5-a]pyrimidin-7-amine 2-(l,l-difluoroethyl)-5-methyl-N-[4-(pentafluoro- 6– sulfanyl)phenyl]...
View ArticleClik here to view.
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]-,...
View Article