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*  Cyproterone acetate
Han C, Davis CB, Wang B (6 January 2010). Evaluation of Drug Candidates for Preclinical Development: Pharmacokinetics, ... Adverse Drug Reactions Advisory Committee (February 2004). "Australian Adverse Drug Reactions Bulletin, Volume 23, Number 1". ... Muller (19 June 1998). European Drug Index: European Drug Registrations, Fourth Edition. CRC Press. pp. 79-. ISBN 978-3-7692- ... www.drugs.com/international/cyproterone.html Index Nominum 2000: International Drug Directory. Taylor & Francis. January 2000. ...
*  Vaccine trial
A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and ... The preclinical stages are also necessary to determine approximate dose ranges and proper drug formulations (i.e., tablet, ... are necessary components of the preclinical stage. Other drug trials focus on the pharmacodynamics and pharmacokinetics; ... The drug is introduced into a small cohort of healthy volunteers. Vaccine escalation studies aim to minimize chances of serious ...
*  Sara Radcliffe
... biotechnology and assistant vice president of pre-clinical drug safety evaluation. At PhRMA, she advocated for technologies in ... Her work included evaluation and communication of DNA research and Pharmacogenetics. She was also employed by the ... "Careers and Recruitment - Regulatory Affairs". Nature Reviews Drug Discovery (8): 255. March 2009. doi:10.1038/nrd2843. ...
*  The CERN Foundation
... 's research is based on a model that includes preclinical evaluation of new and FDA-approved drugs in ... The drugs are tested in clinical trials involving both pediatric and adult cancer centers from within the CERN network. The ... This project serves as a testing ground for new diagnostic and drug discoveries made in Projects Two and Three. Tumor Profiling ... The project also provides insights into the design of CERN's future clinical trials, and all CERN trials include evaluation of ...
*  IIT Research Institute
This work involves molecular diagnostics, drug and vaccine efficacy evaluations, drug and vaccine safety evaluations, and ... Mechanistic studies are performed at the cell, biochemical, and molecular levels, and preclinical drug discovery and ... The various research efforts in the foregoing divisions supports Drug Discovery Division with Investigational New Drug (IND) ... safety evaluations, and drug discovery and development. In 2006, IITRI formed Technology Research, Inc. (TRI), as a wholly ...
*  Wang Aiping (physician)
... pre-clinical safety evaluation of new drugs and Practice, drug pharmacology and Pharmacology Research Methodology, and ... From 2001 to date he was appointed Director and researcher of Drug Safety Evaluation and Research, at the Academy of Medical ... He was the former member of the Military Drug Evaluation Specialist Database, and former member of the Specialist Committee of ... Since 2001, he has been Director of Drug Safety Evaluation and Research at the Academy of Medical Sciences, Peking Union ...
*  Armed Forces Radiobiology Research Institute
... drug candidates and biological dose assessment technologies are developed up to and through preclinical testing and evaluation ... The program seeks to develop prophylactic and therapeutic drugs, such as Ex-Rad, that prevent and treat radiation injuries and ...
*  Satraplatin
"Preclinical antitumor evaluation of bis-acetato-ammine-dichloro-cyclohexylamine platinum(IV): an orally active platinum drug" ( ... Once the molecule makes it to the bloodstream the drug loses its acetate groups. At this point the drug is structurally similar ... Since the drug is now structurally similar to cisplatin its mechanism of action is also very similar. The chlorine atoms are ... A large problem with cisplatin and other platinum based anti-cancer drugs is that the body can develop resistance to them. A ...
*  Minimum inhibitory concentration
As such, MICs are usually the starting point for larger preclinical evaluations of novel antimicrobial agents. Tripathi, K.D. ( ... The first step in drug discovery is often the screening of a library drug candidate for MICs against bacteria of interest. ... p 1103 ISBN 1-55581-255-4 O'Neill, AJ; Chopra, I (August 2004). "Preclinical evaluation of novel antibacterial agents by ... culturing the organism infecting a patient with available antibiotic drugs and determining the MICs, is important to identify ...
*  Fusidic acid
"Preclinical evaluation of novel antibacterial agents by microbiological and molecular techniques. Expert Opin. Investig". Drugs ... The drug is licensed for use as its sodium salt sodium fusidate, and it is approved for use under prescription in South Korea, ... Patients taking the drug should tell their doctors if they notice these side effects. In vitro susceptibility studies of U.S. ... Fusidic acid should not be used on its own to treat S. aureus infections when used at low drug dosages. However, it may be ...
*  Pharmaceutical industry
In the UK, the Medicines and Healthcare Products Regulatory Agency approves drugs for use, though the evaluation is done by the ... This process generally involves submission of an Investigational New Drug filing with sufficient pre-clinical data to support ... Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered ... Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year. This approval comes only after ...
*  Discovery and development of dipeptidyl peptidase-4 inhibitors
Based on this data, alogliptin was chosen for preclinical evaluation. In January 2007 alogliptin was undergoing the phase III ... In recent years, new drugs have been developed, based on continuing research into the mechanism of insulin production and ... It is a well-known DPP-4 inhibitor developed by GlaxoSmithKline (GSK). Biological evaluations have shown that the S- ... In 1999, Merck started a drug development program on DPP-4 inhibitors. When they started internal screening and medicinal ...
*  Biologics license application
Pre-clinical studies Clinical studies Labeling Some biological products are regulated by the Center for Drug Evaluation and ... New drug application Investigational new drug "Biologics License Applications (BLA) Process (CBER)". FDA. 2015. Retrieved July ... A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics ... A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will ...
*  Quazepam
August 1987). "Preclinical safety evaluation of the benzodiazepine quazepam". Arzneimittelforschung. 37 (8): 906-13. PMID ... Two types of drug misuse can occur either recreational misuse is where the drug is taken to achieve a high or when the drug is ... This makes quazepam unique in the benzodiazepine family of drugs. Quazepam is a drug with the potential for misuse. ... Mendels J, Stern S (1983). "Evaluation of the short-term treatment of insomnia in out-patients with 15 milligrams of quazepam ...
*  GW-803430
"Preclinical evaluation of melanin-concentrating hormone receptor 1 antagonism for the treatment of obesity and depression". The ... Drugs of the Future. 2007;32(9):809. Gehlert DR, Rasmussen K, Shaw J, Li X, Ardayfio P, Craft L, Coskun T, Zhang HY, Chen Y, ... GW-803430 (GW-3430) is a drug used in scientific research and is a selective non-peptide antagonist at the melanin ...
*  Hit to lead
... preclinical drug development → clinical drug development The hit to lead stage starts with confirmation and evaluation of the ... Cheminformatics Drug design Drug development Drug metabolism Fragment-based lead discovery (FBLD) High-content screening (HCS) ... only one in every 5,000 compounds that enters drug discovery to the stage of pre-clinical development becomes an approved drug ... only one in every 5,000 compounds that drug companies discover and put through preclinical testing becomes an approved drug. Of ...
*  Crown Bioscience International
The company has at least 8,000 viable human tumors that can be used for the evaluation of drugs used in oncology studies. ... Fassbender, Melissa (4 January 2018). "JSR: CrownBio purchase to support 'major opportunity' in preclinical space". Outsourcing ... The company keeps a library of cancer models used for drug-testing that precedes clinical trials. The company applied for ... CrownBio's signature products include a library of xenograft models used for drug testing and contract research services for ...
*  PL-6983
The drug has reportedly been in pre-clinical development for all medical indications since 2008.[1] Palatin has stated that "We ... are focusing development efforts on bremelanotide for [female sexual dysfunction], but are continuing evaluation of PL-6983."[2 ... List of investigational sexual dysfunction drugs PF-00446687 THIQ Melanotan II Natasha Mitchner (2009). Hypoactive Sexual ...
*  HERG
Food and Drug Administration issued recommendations for the establishment of a cardiac safety profile during pre-clinical drug ... The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human ... both of which can result in decreased channel function and drug-induced (acquired) long QT syndrome. Among the drugs that can ... Preclinical hERG studies should be accomplished in GLP environment. The hERG gene was first named and described in a paper by ...
*  Melanin-concentrating hormone receptor 1
"Preclinical evaluation of melanin-concentrating hormone receptor 1 antagonism for the treatment of obesity and depression". The ... CNS Drug Reviews. 11 (4): 341-52. doi:10.1111/j.1527-3458.2005.tb00052.x. PMID 16614734. Gehlert DR, Rasmussen K, Shaw J, Li X ... "Synthesis and biological evaluation in vitro of a selective, high potency peptide agonist of human melanin-concentrating ... CNS Drugs. 20 (10): 801-11. doi:10.2165/00023210-200620100-00002. PMID 16999451. Hervieu GJ (Apr 2006). "Further insights into ...
*  Anthony Clifford Allison
"Risk Evaluation and Mitigation Strategy (REMS) Under Review for CellCept and Myfortic". U.S. Food and Drug Administration. ... Taylor, DO; Ensley, RD; Olsen, SL; Dunn, D; Renlund, DG (1994). "Mycophenolate mofetil (RS-61443): preclinical, clinical, and ... it would become an immunosuppressive drug for autoimmune diseases and organ transplantation. In 1981 he decided to go for drug ... After successful clinical trials, the compound was approved for use in kidney transplant by the US Food and Drug Administration ...
*  Gantacurium chloride
... acid esters were too unstable for isolation in sufficient quantities for extensive in vitro or in vivo preclinical evaluations ... The holy grail of research in the neuromuscular blocking drugs arena for the better part of the 1980s and 1990s has been to ... its propensity for eliciting histamine release in humans with more intensity than that observed during pre-clinical evaluation ... In this sense, gantacurium is a first in its class non-depolarizing neuromuscular blocking drug to arguably challenge the ...
*  Safety pharmacology
7]. FDA U.S. Department of Health and Human Services Food and Drug Administration - Center for Drug Evaluation and Research ( ... 2]. ICH S6(R1): Preclinical safety evaluation of biotechnology-derived pharmaceuticals. [3]. ICH S9: Nonclinical evaluation for ... 8]. FDA U.S. Department of Health and Human Services Food and Drug Administration - Center for Drug Evaluation and Research ( ... If these evaluation efforts succeed, CiPA will become a Safety Pharmacology screening tool for drug research and development ...
*  TopoTarget
... has several drugs in preclinical development. A current target is Heat Shock Protein 90 (HSP90). HSP90 is key in ... LEO Pharma sold TopoTarget the license to its preclinical HDAC inhibitor, which is also undergoing evaluation as a treatment ... Currently TopoTarget has nine drugs in clinical development, as well as an extensive portfolio of small molecule drug ... APO866, a drug that inhibits the growth of human tumors, is a potent and specific inhibitor of a key enzyme that is involved in ...
*  QS21
"Synthesis and preclinical evaluation of QS-21 variants leading to simplified vaccine adjuvants and mechanistic probes". J Am ... CS1 maint: Multiple names: authors list (link) "BLA Approval" (PDF). Food and Drug Administration. October 20, 2017. Quillaja ... QS-21 is currently under clinical evaluation as an additive for various trial vaccines, including those for HIV, malaria and ...