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энкломифен Enclomiphene citrate إينكلوميفان
Enclomiphene citrate NDA FILED Hypogonadism, Repros Therapeutics An estrogen receptor (ER) antagonist potentially for treatment of hypogonadotropic hypogonadism. ICI-46476; RMI-16289 CAS...
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FDA releases draft guidance on the use of comparability protocols for post...
DRUG REGULATORY AFFAIRS INTERNATIONAL The US FDA released a draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”. The...
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Five new General Chapters in the European Pharmacopoeia on Genotoxic...
DRUG REGULATORY AFFAIRS INTERNATIONAL During the manufacture of APIs as sulfonate salts, esters of sulfonic acid may develop in undesired chemical side reactions. Recently, five new General Monographs...
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New FDA Draft Guidance ‘Data Integrity and Compliance with cGMP’ published
DRUG REGULATORY AFFAIRS INTERNATIONAL In the last years, the topic “data integrity” has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the...
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VX-? , an Azaindolyl-Pyrimidine Inhibitor of Influenza Virus Replication from...
VX-? An Azaindolyl-Pyrimidine Inhibitor of Influenza Virus Replication from Vertex SYNTHESIS COMING…….. CAS 1259498-06-0 MF C23 H27 F2 N7 O, MW, 455.50 1-Piperidinecarboxamide,...
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Cebranopadol hemicitrate, セブラノパドール
Cebranopadol hemicitrate, GRT-6005 Phase III Grünenthal GmbH innovator SYNTHESIS COMING WATCH OUT………. A mu-opioid agonist for treatment of neuropathic pain and pain due to osteoarthritis. CAS...
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Boldenone Undecylenate
Boldenone Undecylenate cas 13103-34-9, C30 H44 O3, 452.67 Androsta-1,4-dien-3-one, 17-[(1-oxo-10-undecenyl)oxy]-, (17β)- Androsta-1,4-dien-3-one, 17β-hydroxy-, 10-undecenoate (7CI,8CI)...
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Elpamotide
Elpamotide str drawn bt worlddrugtracker Elpamotide L-Arginyl-L-phenylalanyl-L-valyl-L-prolyl-L-alpha-aspartylglycyl-L-asparaginyl-L-arginyl-L-isoleucine human soluble (Vascular Endothelial Growth...
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Oliceridine
Oliceridine N-[(3-methoxythiophen-2-yl)methyl]-2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethan-1-amine [(3-Methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-...
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Galunisertib
Galunisertib Phase III A TGF-beta receptor type-1 inhibitor potentially for the treatment of myelodysplastic syndrome (MDS) and solid tumours. LY-2157299 CAS No.700874-72-2...
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Quality Documentation of API mix in the Marketing Authorisation Procedure
DRUG REGULATORY AFFAIRS INTERNATIONAL For different reasons, the manufacture of APIs may sometimes require adding excipients. In the context of an authorisation procedure, this practice reveals to be...
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EMA publishes finalised Process Validation Guideline for Biotech Products
DRUG REGULATORY AFFAIRS INTERNATIONAL Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been...
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Sun Pharma and Merck & Co. Inc. Enter into Licensing Agreement for...
Tildrakizumab (MK-3222) Company Merck & Co. Inc. Description Anti-IL-23 antibody Molecular Target Interleukin-23 (IL-23) Mechanism of Action Antibody Therapeutic Modality Biologic: Antibody Latest...
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Processes for Constructing Homogeneous Antibody Drug Conjugates
Antibody drug conjugates (ADCs) are synthesized by conjugating a cytotoxic drug or “payload” to a monoclonal antibody. The payloads are conjugated using amino or sulfhydryl specific linkers that react...
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A New Antibiotic...
(E)-3-(3-Carboxyphenyl)-2-(4-ethynylstyryl)quinazolin-4(3H)-one (E)-3-(2-(4-Cyanostyryl)-4-Oxoquinazolin-3(4h)-Yl)benzoic Acid; 1624273-22-8 CAS NA SALT 1624273-21-7 CAS INNOVATORS University Of...
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Nolatrexed Dihydrochloride
Nolatrexed NDA Filed in china A thymidylate synthase inhibitor potentially for the treatment of hepatocellular carcinoma and nasopharyngeal cancer. AG-337 CAS No. 147149-76-6 (free) free form data...
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CADROFLOXACIN
Cadrofloxacin , CS 940 3-Quinolinecarboxylic acid, 1-cyclopropyl-8-(difluoromethoxy)-6-fluoro-1,4-dihydro-7-[(3S)-3-methyl-1-piperazinyl]-4-oxo-, hydrochloride (1:1) UNII-1YOQ7J9ACY; 153808-85-6;...
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Arbaclofen
Arbaclofen placarbil (3R)-3-(4-chlorophenyl)-4-[[(1S)-2-methyl-1-(2-methylpropanoyloxy)propoxy]carbonylamino]butanoic acid NDA filed A GABA (B) receptor agonist potentially for the treatment of muscle...
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FDA issues rule for data collection of antimicrobial sales and distribution...
FDA issues rule for data collection of antimicrobial sales and distribution by animal species 05/10/2016 09:28 AM EDT Additional data help further target efforts to ensure judicious use of medically...
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