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Topic: Drug development


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In the News (Tue 29 Dec 09)

  
  Mass High Tech
Imaging is playing a role in the development of drugs for a variety of disease processes including cancer, cardiovascular disease, central nervous system disease (such as stroke, dementia, multiple sclerosis), osteoporosis, arthritis, obesity, diabetes and others.
In the case of rheumatoid arthritis, if a drug developer seeks to claim that a drug modifies the disease process, or does more than just relieve symptoms, the FDA has determined that the beneficial effect on the joints of the hands and feet must be demonstrated using radiographs.
Radiology is inherently a technology-intensive field, and the use of medical imaging in drug development requires the application of a range of technologies and systems.
www.masshightech.com /displayarticledetail.asp?art_id=62395&cat_id=95   (1138 words)

  
 NPS - Drug Development
Drug candidates range from being in the earliest stages of discovery research to late-stage clinical trials.
The most advanced drug candidates include PREOS® (recombinant human parathyroid hormone) for treating osteoporosis which has completed Phase 3 clinical trials, and teduglutide for treating gastrointestinal disorders (GI), which is in a pivotal Phase 3 trial.
Calcilytics are small molecule drugs for treating osteoporosis, and several calcylitic molecules are currently in proof-of-principle Phase 1 clinical trials.
www.npsp.com /drug_development/index.php   (239 words)

  
 Column - Drug Development in Psychiatry and Genomics: From E. Coli to Man
The common mechanism is to produce a drug capable of inhibiting a mechanism (i.e., an enzyme or ribosome) vital to a biochemical pathway essential to either maintenance of cellular integrity ("cidal" drugs) or reproductive function ("static" drugs).
The development of psychiatric medications has until now followed a pattern involving, first, the chance discovery of clinically useful agents, followed by the development of newer refined drugs based on a knowledge of the pharmacology of the earlier chance discovery drugs.
This process will advance new drug discovery and reduce the inherent risk for drug developers by enabling them to avoid problems such as were encountered with drugs like fluoxetine and paroxetine, which inadvertently inhibited enzymes responsible for oxidative drug metabolism in humans while also blocking serotonin uptake, their desired mechanism of action.
www.preskorn.com /columns/0111.html   (3338 words)

  
 Chapter 5: Development of Cannabinoid Drugs | Marijuana and Medicine: Assessing the Science Base | Institute of Medicine   (Site not responding. Last check: 2007-11-06)
Drug development is performed largely by pharmaceutical companies, but some targeted drug development programs are sponsored by the National Institutes of Health (NIH) to stimulate further development and marketing by the private sector.
Drug development begins with discovery, that is, the synthesis and purification of a new compound with expected biological activity and therapeutic value.
Unimed and Roxane are developing, or considering development of, five new indications for Marinol: disturbed behavior in Alzheimer's disease, nausea and vomiting in HIV patients who are receiving combination therapy, spasticity in multiple sclerosis, intractable pain, and anorexia in cancer and renal disease.
www.nap.edu /html/marimed/ch5.html   (10486 words)

  
 Drug Development Research, Division of Microbiology and Infectious Diseases, NIAID   (Site not responding. Last check: 2007-11-06)
Other recent findings have identified several drugs with activity against members of the poxvirus family, which might be helpful in the event of a bioterrorist attack using smallpox.
For example, research projects on malaria include identification and characterization of unique parasite biochemical pathways that may serve as targets for drugs; determination of mode of action of existing and potential drugs; and analysis of the mechanisms by which the parasite has become resistant to existing drugs.
The Division also supports research focused on the development of topical microbicides, which are bactericidal or virucidal intravaginal preparations that would be used by women to prevent sexually transmitted infections.
www.niaid.nih.gov /dmid/drug   (1066 words)

  
 Organized crime - Wikipedia, the free encyclopedia
In order for a criminal organization to prosper, some degree of support is required from the society in which it lives.
People in the judiciary, police forces, and legislature are especially targeted for control by organized crime via bribes, threats, or a combination.
Financing is made easier by the development of a customer base inside or outside the local population, as occurs for instance in the case of drug trafficking.
en.wikipedia.org /wiki/Racketeering   (682 words)

  
 Drug Development - Novartis.com
Once the initial safety profile is established, the drug candidate is used in a PoC trial (i.e., it is given to a small group of patients or healthy volunteers to verify the mechanism of action and to test if the new candidate is efficacious in human disease).
For the registration of the new drug, the results from all preclinical and clinical studies are collected and analyzed together with the quality data and the description of the manufacturing process.
During development and once a drug is on the market, we maintain a constant watch for adverse events and report these to the regulatory authorities.
www.nibr.novartis.com /OurScience/drug_development.shtml   (631 words)

  
 Thailand. The Columbia Encyclopedia, Sixth Edition. 2001-05
Thailand has substantial hydroelectric potential, which is being developed; projects have been constructed on the Ping, Mekong, Phong, and Songkhram rivers.
Industry is growing and is centered chiefly in the processing of agricultural products; rice milling is by far the most important, followed by sugar refining, textile spinning and weaving, and the processing of rubber, tobacco, and forest products.
The Thais captured the Khmer town of Sukhothai, in N central Thailand, and a new Thai nation, with its capital at Sukhothai, soon developed.
www.bartleby.com /65/th/Thailand.html   (3047 words)

  
 OMR's Obesity 101 -- Bringing a new drug to market   (Site not responding. Last check: 2007-11-06)
An injectable drug will be used by many fewer patients than an oral formulation, and if that drug is not likely to be used by classes of patients who take injections anyway, like insulin dependent diabetics, a drug may be abandoned for those reasons alone.
It can take 10 or 12 years from the time a new drug is discovered until it goes to market, and it costs the average company $359 million to bring a new medication from the laboratory to the pharmacist's shelf, according to a 1993 report by the Congressional Office of Technology Assessment.
In the preclinical phase a new drug is synthesized, and the pharmacological activity and therapeutic potential are tested in animal studies and on tissue samples, enzymes, cloned receptor sites and computer models.
www.obesity101.com /drugdev.htm   (851 words)

  
 Pediatric Drug Development
Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee.
Pediatric Subcommittee; Anti-Infective Drugs Advisory Committee, 4/23/1999 (5/14/1999)
The Division of Pediatric Drug Development (DPDD) is part of the Office of Counter-Terrorism and Pediatric Drug Development (OCTAP), in the Office of the Center Director, CDER.
www.fda.gov /cder/pediatric   (1770 words)

  
 Drug Development Technology - Rephartox - Pharmaceutical Research and Full Drug Development   (Site not responding. Last check: 2007-11-06)
The company was founded in 1991 by dr. Ben Rademaker with the aim of bridging university research with the pharmaceutical industry.
Rephartox evolved from pre-clinical research in pharmacology and toxicology and now offers services that cover the full development of new drugs, including preparation of a master plan, drug discovery, pre-clinical research, clinical research and registration.
At the heart of our business are research and development of medical products, classical and biotech, as well as products from natural resources.
drugdevelopment-technology.com /contractors/contract_research/rephartox   (430 words)

  
 Drug Discovery & Development   (Site not responding. Last check: 2007-11-06)
However, as the drug is being developed, the biologists often go back to fill in the missing pieces on how the drug works.
The company's development speed is also attributed to the fact that the teams perform animal testing very early in the drug cycle.
The project ended with the discovery of a promising drug candidate that was later licensed to Novartis [Sandoz at the time] and the creation of Fuji ImmunoPharmaceuticals in the United States in 1993.
www.dddmag.com /PRArchivebyIssue.aspx?RELTYPE=CVS&YEAR=2004&MONTH=05   (2608 words)

  
 FuturePundit: Proposal For Open Source Drug Development
Note that open source drug development is becoming possible because of advances in computer and communications technology.
It may be possible for companies to develop similar compounds that are patentable that work the same way or take artemisinin or one of its active forms and attach it to antibodies to target cancer cells and get a patentable treatment that way.
The future drugs in the US are developed by universities (with government money) and handed to companies to run the trials and profit from them.
www.futurepundit.com /archives/002580.html   (1583 words)

  
 Drug discovery & development glossary
Drug 'developability' assessment has become an increasingly important addition to traditional drug efficacy and toxicity evaluations, as pharmaceutical scientists strive to accelerate drug discovery and development processes in a time- and cost-effective manner.
Drug design is generally computer- assisted molecular modeling and does not include pharmacokinetics, dosage analysis, or drug administration analysis.
The input of biocomputing in drug discovery is twofold: firstly the computer may help to optimise the pharmacological profile of existing drugs by guiding the synthesis of new and "better" compounds.
www.genomicglossaries.com /content/drug_discovery_gloss.asp   (6684 words)

  
 Preclinical Drug Development > Pharmaceutical Preclinical Drug Development Consultants, Outsource Drug Discovery ...
We design and direct the preclinical drug development science necessary to achieve timely completion of appropriate preclinical drug development research expending the necessary resources to address the scientific issues.
Bioanalytical method development, in vitro metabolism and metabolite isolation and synthesis and use of radiolabeled compounds in the preclinical drug development stages.
Pharma Directions is a preclinical drug development consulting firm serving our pharmaceutical research clients, either as independent Bio Pharma Drug Discovery consultants or as part of an integrated team, in order to help get their pharmaceutical drug product through the preclinical drug development phases of production swiftly and at minimal costs.
www.pharmadirections.com /preclinical-drug-development.htm   (314 words)

  
 Quest for hot new drugs spikes costs - 11/23/03   (Site not responding. Last check: 2007-11-06)
Like other drug researchers, they can spend their careers searching for new medicines only to retire without ever working on a drug that makes it to a pharmacy shelf.
Those odds increase research costs, to $802 million per drug in 2002, and contribute to high price tags for consumers -- all driving a national debate on prescription drug costs that is prompting lawmakers to debate an unprecedented $400 billion reform to Medicare.
Industrywide, the introduction of new drugs plunged last year to 17 from a high of 53 in 1996, despite a near doubling in annual research spending to $32 billion.
www.detnews.com /2003/health/0311/23/a01-332562.htm   (1309 words)

  
 Drug Discovery and Development - RTI International
Drug discovery and development is a core research activity at RTI International.
For example, Taxol® which was discovered at RTI by Dr. Mansukh C. Wani and the late Dr. Monroe Wall, has become one of the world’s leading treatment options in the fight against multiple forms of cancer.
From this celebrated achievement to our current work in screening natural products to derive anti-cancer compounds, developing new compounds for the treatment of drug addiction, depression, obesity, and male fertility, RTI has been at the forefront of drug discovery research.
www.rti.org /page.cfm?objectid=F15F1785-4917-49BE-9E06CFF15672C697&nav=428   (487 words)

  
 DTP - Drug Development Group (DDG)
In exceptional cases, the Director may approve the development of agents whose priority rating from the DDG is low, if the Director considers the scientific or societal impact to be substantial.
Note, however, that compounds at all stages of development are considered on an individual basis, and additional criteria may apply.
Uniqueness : a discussion of related or similar molecules already under development by NCI or known to be in development under industrial sponsorship, and why the NCI should undertake development in light of this.
dtp.nci.nih.gov /docs/ddg/ddg_descript.html   (1656 words)

  
 CDDS - Center for Drug Development Science   (Site not responding. Last check: 2007-11-06)
The Center for Drug Development Science, established in late 1994 at the Georgetown University Medical Center, seeks to advance the science, strategic planning, and management processes of drug development and to establish clinical drug development science as a rigorous academic discipline through four programs:
Investigating contemporary drug development practices and evaluating and developing novel scientific methodologies.
Contributing to the education of practitioners of drug and regulatory science.
cdds.georgetown.edu   (190 words)

  
 DRUG DEVELOPMENT AND APPROVAL PROCESS
The U.S. system of new drug approvals is perhaps the most rigorous in the world.
The studies also determine how a drug is absorbed, distributed, metabolized and excreted, and the duration of its action.
Discovering and developing safe and effective new medicines is a long, difficult and expensive process.
www.allp.com /drug_dev.htm   (592 words)

  
 PharmQuest Corporation - Accelerating Drug Development
PharmQuest develops and markets a suite of innovative products and solutions to enable pharma/biotech companies to maximize their RandD investment and facilitate electronic submissions to regulatory agencies.
PharmQuest's products are developed using standards-based, open-architecture software modules that can be fully integrated to enhance project, information and knowledge management company-wide.
PharmQuest’s ToxQuest™ family of products is developed working with the industry and FDA reviewers.
www.pharmquest.com   (234 words)

  
 Drug Discovery Program   (Site not responding. Last check: 2007-11-06)
The University of Pittsburgh Medical Center created the Drug Development Program in 1995 to promote the development of promising drug leads within the academic setting.
The impetus for the creation of this program was the desire to more actively link university researchers in multi-disciplinary efforts to discover and add value to new drug leads, and to foster the creation of locally-based drug discovery and development companies.
The Drug Development Program currently has seven ongoing projects from across the spectrum of the University Medical Center, representing faculty from Infectious Diseases, the Graduate School of Public Health, Clinical Pharmacology, Anesthesiology and Critical Care, Pharmacology, Chemistry, and others.
www.upmc.edu /clinpharm/Discovery.htm   (370 words)

  
 Drug Product Development
Currently, because of its strong faculty, the University is very involved in the Drug Discovery phase of drug development, but is significantly lacking in involvement in the Preformulation and Early Formulation phase as well as in the Assessment of Efficacy and Toxicity in Animals.
There is a consensus within this campus community that many potential drugs discovered by University faculty, students, and other research scientists, and patented through WARF, would have a greater chance for successful development and licensing, with greater financial benefit to the University, if more complete pharmaceutical development could be carried out within the University.
However, the University has not yet effectively developed programs to translate the discovery of drugs to a point where more complete pre-clinical evaluation of efficacy or toxicity can be completed.
www.pharmacy.wisc.edu /pes/drug.htm   (246 words)

  
 Tufts CSDD
U.S. Pediatric Studies Have Led to New Labeling for Nearly 100 Drugs
The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group affiliated with Tufts University.
Tufts CSDD's mission is to provide strategic information for drug developers, regulators, and policy makers on improving the quality and efficiency of pharmaceutical development, research, and utilization.
csdd.tufts.edu   (159 words)

  
 Child Development   (Site not responding. Last check: 2007-11-06)
Early Child Development - World Bank - World bank: education: early child development site is a knowledge source designed to assist policy makers, program managers, and practitioners in their.
Child Development Resource Connection Peel - Founded in 1994, child development resource connection peel (formerly known as peel child care committee) collaborates with community partners to promote the quality care of children up to 12 years.
Sum Child Development, Inc. - Snyder, union, mifflin child development, inc. 14 south 11th street mifflinburg, pa 17844 (570) 966-2845 lewisburg children's center the latest news and information for the new center in lewisburg.
www.7steps.org /Child_Development/more2.html   (292 words)

  
 Seattle Genetics Drops Drug Development - Forbes.com   (Site not responding. Last check: 2007-11-06)
Seattle Genetics Inc. said Wednesday that it is dropping development of its experimental SGN-15 lung cancer drug because results from a mid-stage trial, while "encouraging," were not impressive enough to justify investment by the small biotech firm in a large, late-stage study.
This trial was designed mainly to see if a different dosing schedule could improve the effectiveness of the drug, which showed a six-week survival benefit for patients in last year's mid-stage study.
Two drugs that have yet to enter clinical trials use the "second generation" version of the company's antibody-yoking technology.
www.forbes.com /home_asia/feeds/ap/2005/07/06/ap2126333.html   (674 words)

  
 Drug Development - Rx&D   (Site not responding. Last check: 2007-11-06)
Identifying compounds to treat complex diseases and testing these therapies to ensure safety and efficacy is a costly, risky, and time-consuming process.
Estimated average costs of research and development required for each medicine that reaches the market are about $802 million US.
It takes a long time for pharmaceutical companies to develop and test new medicines - on average it can take 10-12 years.
www.canadapharma.org /Patient_Pathways/Drug_Process   (208 words)

  
 Locum Int - Journal of Drug Development - Editorial
Emphasis is placed on US and EC exposure to the Drug Development Industry with special reference to the on-time development of EU Dossiers, NDA and ANDA submissions.
The Chemistry, Manufacture and Controls (CMC) section of NDA development cover hands-on nuts-and-bolts developmental issues that vary across the full drug development spectrum from documentation requirements, excipients specifications, development (pre-to-final) formulation, scale-up, analytical, cleaning and process validation protocols necessary for the entire drug development process.
The International Journal of Drug Development provides a free exchange of scientific knowledge while promoting the innovative, generic and OTC pharmaceutical sciences.
www.locumusa.com /journals/development_journal   (377 words)

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