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FDA publishes new Guidance on Validation of Analytical Methods
The FDA has published a new Guidance on the validation of analytical methods which shall replace the 14 years old existing Guideline on the topic. More details about the contents of this highly...
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FDA Issues Draft Guidance on NCE Exclusivity Determinations
Feb 25, 2014 FDA has released draft guidance on the agency’s interpretation of the five-year new chemical entity (NCE) exclusivity provisions as they apply to certain fixed-combination drug products...
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Drug discovery
In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the...
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The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective
How Drugs are Developed and Approved The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test...
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LUPIN.. giant leap forward » All About Drugs
LUPIN.. giant leap forward » All About DrugsFiled under: COMPANIES, Uncategorized Tagged: drugs, lupin
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Actelion’s novel antibiotic Cadazolid receives US FDA Qualified Infectious...
CADAZOLID, ACT-179811 1025097-10-2...
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2013 FDA drug approvals
Originally posted on Sussex Drug Discovery Group: This analysis by Asher Mullard published in Nature Reviews Drug Discovery ( 2014,13, 85-89) reports the new drugs approved by FDA in 2013. From a...
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Ancient Chinese medicine put through its paces for pancreatic cancer
Originally posted on lyranara.me: The bark of the Amur cork tree ( Phellodendron amurense ) has traveled a centuries-long road with the healing arts. Now it is being put through its paces by science...
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BARDOXOLONE.. Upcoming blockbuster
BARDOXOLONE METHYL Methyl 2-cyano-3,12-dioxooleana-1,9(11)dien-28-oate methyl 2-cyano-3, 12-dioxooleana-1,9(11)-dien-28-oate 2-Cyano-3,12-dioxoolean-1,9(11)-dien-28-oic acid methyl ester...
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BORTEZOMIB, PS 341
BORTEZOMIB A proteasome inhibitor. EMA:Link, US FDA:link [(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid...
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Uncialamycin
Uncialamycin (1aS,11S,11aR,18R)-3,18-Dihydroxy-11a-[1(R*)-hydroxyethyl]-9,10,11,11a-tetrahydro-4H-11,1a-[3]heptene[1,5]diynonaphtho[2,3-h]oxireno[c]quinoline-4,9-dione 439.4163 C26 H17 N O6...
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Trial to test laser acupuncture treatment for osteoarthritis
Originally posted on lyranara.me: The potential for laser acupuncture to provide painless and effective treatment for osteoarthritis knee pain is being put to the test in a clinical trial beginning in...
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Cidofovirסידופוביר سيدوفوفير
CIDOFOVIR (S)-1-(3-Hydroxy-2-phosphonylmethoxypropyl)cytosine [(S)-2-(4-Amino-2-oxo-1,2-dihydropyrimidin-2-yl)-1-(hydroxymethyl)ethoxymethyl]phosphonic acid 113852-37-2 CAS 120362-37-0 (Na salt)...
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Lysosomal Storage Disorders: Orphan Drugs For Niemann-Pick Disease
Originally posted on Orphan Druganaut Blog: This is the sixth Blog Post in a series that will examine Lysosomal Storage Disorders (LSDs) in the rare disease and orphan drug space. This Blog Post...
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Indian Regulators promote two levels of GMP
GMP deviations and even data falsification have been identified in a number of companies in India. How is it possible that interpretation of FDA and EU authorities on one side and the Indian authority...
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Japanese Pharmacopoeia and Japanese GMP Regulations available online
Japanese Pharmacopoeia and Japanese GMP Regulations available online On Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) website, you can download documents on GMP as well as on marketing...
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FDA Secure Supply Chain Pilot Program: 13 companies prequalified
FDA Secure Supply Chain Pilot Program: 13 companies prequalified In August 2013, the FDA initiated the so called Secure Supply Chain Pilot Program (SSCPP) to enhance the security of imported drugs....
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PIRODAVIR
Pirodavir, R-77975 4 – [2 - [1 - (6-Methyl-3-pyridazinyl)-4-piperidinyl] ethoxy] benzoic acid ethyl ester ethyl 4-{2-[1-(6-methyl-3-pyridazinyl)-4-piperidinyl]ethoxy}benzoate ethyl...
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Cancer-fighting compound in figs and celery targets aggressive breast tumors
Originally posted on lyranara.me: It is rare for a natural molecule to garner the attention of medical researchers for two completely different cancer-fighting properties, but the compound psoralen...
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Pimecrolimus Пимекролимус…For treatment of mild to moderate atopic dermatitis.
Pimecrolimus 137071-32-0 cas (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)- 3-{(E)-2-[(1R,3R,4S)-4-Chloro-3-methoxycyclohexyl]- 1-methylvinyl}-8-ethyl-5,6,8,11,12,13,14,15,16,17,...
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