• sterile
  • Barrier and Isolator designs are used throughout the industries, from sterile injectable drug filling to cytotoxic sterile drug compounding to electronics manufacturing to orange juice filling. (wikipedia.org)
  • This type of strict design and control is important when producing sterile medicines because consumers receiving injections, surgical irrigants, or other "parenterally"-administered drugs are often highly vulnerable to infection. (wikipedia.org)
  • If a negative isolator is used, its intricate design must fulfill two objectives: protect workers outside of the isolator, and assure sterility of sterile drugs inside the isolator. (wikipedia.org)
  • In addition to Isolators, there are also extensive barriers that provide sub-isolation protection, but have a very good track record of reducing hazards to sterile drugs during processing when they are designed and operated properly. (wikipedia.org)
  • 2017
  • Vaisala instruments will measure the air quality in the Helsinki region in a new measurement network to be built by the Smart & Clean project parties -Vaisala, Finnish Meteorological Institute, Helsinki Region Environmental Services Authority HSY, University of Helsinki, Pegasor, and Helsinki Metropolitan Smart & Clean Foundation - during 2017 and 2018. (news-medical.net)
  • The re-negotiations of the prescription drug, generic drug and biosimilar user fee programs will also be at the forefront of CDER's work next year as these agreements with industry need to be ironed out before the programs expire in 2017. (drugwonks.com)
  • In February 2017, the FDA accepted a supplement New Drug Application for ceritinib and granted Priority Review for expanded use of ceritinib. (wikipedia.org)
  • While this is substantially less than several of their other pharmaceuticals, the new indication introduced in 2017 should result in increased sales of the drug. (wikipedia.org)
  • chemists
  • The technique enables chemists to add new functional molecules to previously hard-to-reach positions on existing compounds making it easier for them to generate new drugs and other organic chemicals. (medindia.net)
  • Compared to the traditional method, in which chemists modify only the existing functional groups on a compound, CH activation more directly boosts the complexity of a compound, giving it potentially valuable new properties. (medindia.net)
  • These are from compound classes that chemists use routinely to synthesize new candidate drugs and other useful chemicals," Yu said. (medindia.net)
  • A structurally similar compound, ephedrine, (actually more similar to norepinephrine,) was identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma. (wikipedia.org)
  • Medicinal chemists are largely concerned with synthesizing a large number of compounds as quickly as possible from easily tunable chemical building blocks (usually for SAR studies). (wikipedia.org)
  • medication
  • They are responsible to ensure the healthcare profession is informed of the benefits of the drug along with the safety and the side effects to assist a healthcare profession as the correct information and choices to prescribe medication to the patients. (wikipedia.org)
  • This assumes, of course, that the physician intends that the medication be compounded. (wikipedia.org)
  • The U.S. Pharmacopeia Convention (USP) formally defines compounding as "the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice. (pharmacist.com)
  • Flavor a medication (to make it more palatable for a child or a pet). (pharmacist.com)
  • Traditional compounding is the preparation of a medication to meet the prescriber's exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient. (pharmacist.com)
  • These new regulations forced the drug companies to prove that any new medication they brought to market was safe. (wikipedia.org)
  • Compound Q was flown in from China by a treatment activist and distributed to volunteers who had not responded well to approved medication. (wikipedia.org)
  • regulations
  • Traditionally, US regulations set by the Occupational Health and Safety Administration (OSHA) or the Environmental Protection Agency (EPA) serve as guidance to the manufacturer in providing a safe workplace for employees, a safe environment for the surrounding community, and guidance on disposal of waste materials in the manufacturing process. (internano.org)
  • They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. (wikipedia.org)
  • PhRMA officials said state regulations could create a patchwork of conflicting rules across the states that might do more to confuse sales representatives and doctors than prevent improper perks. (wikipedia.org)
  • Good Manufacturing Practice (GMP) Violations Off Label Marketing Best Price Fraud CME Fraud Medicaid Price Reporting Manufactured Compound Drugs Involve fraud with the Good Manufacturing Practice (GMP) Regulations which require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process, appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on. (wikipedia.org)
  • Certain violations of the Good Manufacturing Practice Regulations may be the basis for a False Claims Act lawsuit. (wikipedia.org)
  • On October 9, 2012, members of the United States Congress asked federal health officials for briefings on the outbreak as a first step toward possible legislative action to strengthen federal drug safety regulations. (wikipedia.org)
  • Scientists
  • Powerful new technique for manipulating the building-block molecules of organic chemistry has been developed by scientists at The Scripps Research Institute. (medindia.net)
  • A custom-built programmable 3D printer can create materials with several of the properties of living tissues, Oxford University scientists have demonstrated. (nanowerk.com)
  • To develop antidotes for chemical agents, such as cyanide and mustard gas, scientists need analytical methods that track not only the level of exposure but also how the drug counteracts the effects of the chemical. (news-medical.net)
  • Chinese scientists are now making these weapons more powerful by remodeling the defect state of the nanorod crystal lattice by adding gold nanodots. (news-medical.net)
  • Delaney saw a divide between the needs of scientists, drug companies, and government agencies on the one hand and patients on the other, with the former insisting on time-consuming drug trials for scientific, litigious and public safety reasons, and the latter demanding a chance to stay alive. (wikipedia.org)
  • chemical
  • This is a basic tool for making novel chemical compounds, and it should have a wide range of applications," said Jin-Quan Yu, PhD, a professor at Scripps Research and senior author of the new report, published in the June 28, 2012 issue of the journal Nature . (medindia.net)
  • Controlled selectivity and reaction efficiency are important goals in synthetic chemistry methods for discovering and manufacturing therapeutic and diagnostic agents," said Robert Lees, PhD, who oversees chemical synthesis grants at the National Institutes of Health's National Institute of General Medical Sciences, which partially supported the work. (medindia.net)
  • Humans are veritable chemical factories-we manufacture thousands of substances and transport them, via our blood, throughout our bodies. (phys.org)
  • More than 130 workers at a Chinese factory making touch screens for Apple iPhones were poisoned by a toxic chemical in 2009, the Taiwanese company said Thursday. (phys.org)
  • By the 1890s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs. (wikipedia.org)
  • Crude drugs, like opium, are from natural sources and usually contain several chemical compounds. (wikipedia.org)
  • A lead compound (i.e. a "leading" compound, not lead metal) in drug discovery is a chemical compound that has pharmacological or biological activity likely to be therapeutically useful, but may still have suboptimal structure that requires modification to fit better to the target. (wikipedia.org)
  • Furthermore, newly invented pharmacologically active moieties may have poor druglikeness and may require chemical modification to become drug-like enough to be tested biologically or clinically. (wikipedia.org)
  • Other factors, such as the ease of scaling up the manufacturing of the chemical, must be taken into consideration. (wikipedia.org)
  • Proposed psychoactive drugs developed in chemical laboratories were first tested in animals and then tested in man. (wikipedia.org)
  • Additionally, the many complex factors associated with chemical plant engineering (for example, heat transfer and reactor design) and drug formulation will be treated cursorily. (wikipedia.org)
  • The patents relate to different structures of the chemical compound as well as methodologies for manufacturing the drug. (wikipedia.org)
  • A cocaine analogue is a (usually) artificial construct of a novel chemical compound from (often the starting point of natural) cocaine's molecular structure, with the result product sufficiently similar to cocaine to display similarity in, but alteration to, its chemical function. (wikipedia.org)
  • Al-Biruni, Avicenna and others described the preparation of hundreds of drugs made from medicinal plants and chemical compounds. (wikipedia.org)
  • inhibit
  • Drug libraries are often tested by high-throughput screenings (active compounds are designated as "hits") which can screen compounds for their ability to inhibit (antagonist) or stimulate (agonist) a receptor of interest as well as determine their selectivity for them. (wikipedia.org)
  • optimize
  • Additionally, researchers have supported combinatorial approaches for taking the most promising analogues currently elucidated and mixing them to the end of discovering novel & efficacious compounds to optimize their utilization for differing distinct specified purposes. (wikipedia.org)
  • additionally
  • Fujitsu and Fujitsu Laboratories Ltd. additionally made repeated improvements to the IT-based drug discovery technologies during the course of the joint research project, increasing both accuracy and performance. (ehealthnews.eu)
  • Additionally, the FDA also gave Breakthrough Therapy designation to the drug for ALK-positive metastatic NSCLC that has metastasized to the brain. (wikipedia.org)
  • synthetic
  • The grant will fund a collaborative project that will seek to use synthetic biology - the design and construction of biological devices and systems - to more effectively create proteins, such as those used in drug manufacture. (nanowerk.com)
  • Process chemistry is the arm of pharmaceutical chemistry concerned with the development and optimization of a synthetic scheme and pilot plant procedure to manufacture compounds for the drug development phase. (wikipedia.org)
  • Most large pharmaceutical process chemistry and manufacturing divisions have devised weighted quantitative schemes to measure the overall attractiveness of a given synthetic route over another. (wikipedia.org)
  • All manufacturing was consolidated in Buffalo, and much attention was given to improving the processes hastily introduced during World War I. Allied's first venture into new markets was the construction of a synthetic ammonia plant near Hopewell, Virginia in 1928. (wikipedia.org)
  • substances
  • It was based on the belief that substances were made up of the four Aristotelian elements, fire, earth, air, and water in different proportions. (wikipedia.org)
  • shortage
  • Experts say most California counties have a shortage of primary care physicians, a problem that may be compounded when millions more people get insurance coverage under the Affordable Care Act. (calhospital.org)
  • pharmacy
  • A 2011 study published in the Dermatologic Surgery journal found that five out of six samples of compounding pharmacy-made Polidocanol - a drug used for the treatment of varicose veins - did not contain the claimed concentrations of the active ingredient, and all six contained impurities. (cnbc.com)
  • Sodium tetradecyl sulfate for sclerotherapy treatment of veins: is compounding pharmacy solution safe? (cnbc.com)
  • What is a compounding pharmacy? (pharmacist.com)
  • Alchemy eventually contributed to the creation of modern pharmacy and the principles of pharmacy compounding. (wikipedia.org)
  • Pharmaceutical compounding is a branch of pharmacy that continues to play the crucial role of drug development. (wikipedia.org)
  • The NECC was classified as a compounding pharmacy. (wikipedia.org)
  • On November 14, 2012, members of a congressional committee investigating the outbreak accused the Food and Drug Administration (FDA) of failing to prevent the crisis by moving too slowly against the Massachusetts pharmacy. (wikipedia.org)
  • The bill would require the Comptroller General (GAO) to report on pharmacy compounding and the adequacy of state and federal efforts to assure the safety of compounded drugs. (wikipedia.org)
  • 1800s
  • The first of these were local apothecaries that expanded from their traditional role distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid 1800s. (wikipedia.org)
  • Patients
  • Treating patients with cells may one day become as common as it is now to treat the sick with drugs made from engineered proteins, antibodies or smaller chemicals, according to UC San Francisco researchers. (nanowerk.com)
  • This ensures that the environment is maintained as contamination-free to safeguard patients who will later be administered the drug. (wikipedia.org)
  • Delaney encouraged the FDA to use a fast-track review procedure for AIDS drugs, reasoning that dying patients could not afford to wait for the results of meticulous and lengthy research. (wikipedia.org)
  • Social changes in attitudes to the ethics of testing drugs and treatments in patients, prisoners, children, and volunteers inhibited the continued development of the science and its abandonment. (wikipedia.org)
  • proteins
  • Researchers at the University of North Carolina at Chapel Hill School of Medicine have 'rationally rewired' some of the cell's smallest components to create proteins that can be switched on or off by command. (nanowerk.com)
  • AMSilk, a spin-off of the Technische Universitaet Muenchen (TUM), has produced the world's first artificial silk fiber that is entirely made of recombinant spider silk proteins. (nanowerk.com)
  • Medicinal
  • Process chemistry is distinguished from medicinal chemistry, which is the arm of pharmaceutical chemistry tasked with designing and synthesizing molecules on small scale in the early drug discovery phase. (wikipedia.org)
  • prescriptions
  • In October 2012, an investigation of the NECC revealed the company had been in violation of its state license because it had been functioning as a drug manufacturer, producing drugs for broad use rather than filling individual prescriptions. (wikipedia.org)
  • affinity
  • Next, the binding affinity of each compound with the target protein is calculated to narrow down the selection using the M2BAR method(3), which is an improvement on high precision activity prediction technology(4). (ehealthnews.eu)
  • morphine
  • Rational drug discovery from plants started particularly with the isolation of morphine, analgesic and sleep-inducing agent from opium, by the German apothecary assistant Friedrich Sertürner, who named the compound after the Greek god of dreams, Morpheus. (wikipedia.org)
  • biological
  • They detail a biological transistor made from genetic material - DNA and RNA - in place of gears or electrons. (nanowerk.com)
  • Before lead compounds can be discovered, a suitable target for rational drug design must be selected on the basis of biological plausibility or identified through screening potential lead compounds against multiple targets. (wikipedia.org)
  • Biological medical products (more commonly called "biologics") represent a growing proportion of approved therapies, but the manufacturing processes of these products are beyond the scope of this article. (wikipedia.org)
  • Safety
  • Others, such as engineers, may be responsible for implementing adequate exhaust systems, filtration, etc., to prevent environmental exposures to byproducts of the manufacturing process, and safety officers to ensure proper disposal of any hazardous materials or other waste materials. (internano.org)
  • In a first-of-its-kind experiment funded by the National Institutes of Health (NIH), Restifo and her team, including Research Associate Robert Kraft, PhD, have uncovered four dozen compounds, most of which are already approved by the FDA, which means they have a known safety record. (bio5.org)
  • This development raises concerns about patient safety and makes a case for proper regulatory control and monitoring. (wikipedia.org)
  • potentially
  • The compounds are potentially useful for at least two types of mental retardation: tuberous sclerosis and Rubinstein-Taybi Syndrome. (bio5.org)
  • Food and Drug Admin
  • FDA Releases Revised Guidance about Animal Drug User Fees, Fee Waivers and Reductions The U.S. Food and Drug Administration (FDA) has is. (blogspot.com)
  • ASDSA President-Elect Mitchel P. Goldman, M.D., testified before the U.S. Food and Drug Administration (FDA) in 2004 about a study he conducted with similar results. (cnbc.com)
  • Though physicians may prescribe drugs for off-label usage known as off-label marketing, the Food and Drug Administration (FDA) prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. (wikipedia.org)
  • Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). (pharmacist.com)
  • The Food and Drug Administration has already asked doctors, clinics, and consumers to stop using any of the pharmacy's products. (kplr11.com)
  • The Drug Quality and Security Act (H.R. 3204) is a law that amended the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs. (wikipedia.org)
  • dosage
  • Providing uncontaminated drugs at consistent, appropriate dosage levels must be of paramount concern," said Dr. Flynn. (cnbc.com)
  • The courts have agreed with the FDA that the Food, Drug, and Cosmetic Act (FDCA) requires information not only on how a product is to be used (e.g., dosage and administration), but also on all the intended uses of the product. (wikipedia.org)
  • molecules
  • Researchers at The Scripps Research Institute have developed a quick and easy way to simultaneously modify dozens of drugs or molecules to improve their disease-fighting properties. (news-medical.net)
  • targets
  • Fujitsu and RCAST began joint research on IT-based drug discovery in June 2011, with Kowa joining in July, conducting research projects around multiple drug discovery targets. (ehealthnews.eu)
  • RCAST took on the role of providing information on drug discovery targets based from a medical perspective. (ehealthnews.eu)
  • inclusive
  • On the international front, Woodcock highlighted FDA's work with the International Conference on Harmonisation (ICH), noting that it "was headed off a cliff," though after "strenuous efforts," FDA was able to help sign new agreements and make the group more inclusive, which should be a boon for negotiating more global standards for drugs. (drugwonks.com)
  • The MAT binding pocket analogous to the lipophilic place on cocaine-like compounds, inclusive of the benzene ring, is approximate to 9 Å in length. (wikipedia.org)
  • state
  • In Dr. Flynn's home state of North Carolina, a young woman fell into a coma and died in 2005 when she used a large amount of compounded numbing agent prior to laser hair removal. (cnbc.com)
  • Cancer
  • Researchers in Sweden have succeeded in taking the next step toward using man-made nanoscale compounds in the fight against cancer. (news-medical.net)
  • While past attempts to treat melanoma failed to meet expectations, an international team of researchers are hopeful that a compound they tested on both mice and on human cells in a petri dish takes a positive step toward creating a drug that can kill melanoma cancer cells without harming nearby healthy cells. (news-medical.net)
  • making cancer treatment more precise and effective. (bio-medicine.org)
  • Ceritinib (INN, trade name Zykadia /zaɪˈkeɪdiːə/ zy-KAY-dee-ə) is a prescription-only drug used for the treatment non-small cell lung cancer (NSCLC). (wikipedia.org)
  • active
  • Among the 120 active compounds currently isolated from the higher plants and widely used in modern medicine today, 80% show a positive correlation between their modern therapeutic use and the traditional use of the plants from which they are derived. (wikipedia.org)
  • Rational
  • Lead compounds are found by characterizing natural products, employing combinatorial chemistry, or by molecular modeling as in rational drug design. (wikipedia.org)
  • scope
  • Within the scope of analogous compounds created from the structure of cocaine, so named "cocaine analogues" retain 3β-benzoyloxy or similar functionality (the term specifically used usually distinguishes from phenyltropanes, but in the broad sense generally, as a category, includes them) on a tropane skeleton, as compared to other stimulants of the kind. (wikipedia.org)
  • known
  • Researchers have developed a promising way to cleanse the environment of volatile organic compounds (VOCs) - some of the most insidious toxins known to humans. (phys.org)
  • Whether routine or rare, intravenous or oral, etc., when a given drug product is made or modified to have characteristics that are specifically prescribed for an individual patient, it is known as "traditional" compounding. (wikipedia.org)
  • In 1989, Project Inform ran an unauthorised trial of a drug known as "Compound Q", made from the extract of a cucumber-like plant grown in southeast Asia. (wikipedia.org)
  • The observed changes were compared to those for known drugs and predicted their behavioral effects. (wikipedia.org)
  • efficacy
  • Definitions of the changes in EEG rhythms were developed that identified and classified psychoactive drugs, monitored the depth of anesthesia, and evaluated the efficacy of the seizures induced in convulsive therapy (electroshock). (wikipedia.org)
  • bulk
  • Nominees, fiduciaries, and ADR depositary make up the bulk of registered shareholders of Novartis stock while individual shareholders make up the lowest percentage. (wikipedia.org)
  • researchers
  • One of the major obstacles to growing new organs _ replacement hearts, lungs and kidneys _ is the difficulty researchers face in building blood vessels that keep the tissues alive, but new findings from the University of Michigan could help overcome this roadblock. (nanowerk.com)
  • development
  • Yu has now established a collaboration with the pharma giant Bristol Myers Squibb to exploit the new technique in drug development and manufacturing. (medindia.net)
  • The cost of research and development for each drug is hundreds of millions of dollars. (wikipedia.org)
  • Some health economists peg the current cost of drug development at US$1.3 billion, others at US$1.7 billion The actual drug discovery and the drug development can take years. (wikipedia.org)
  • standards
  • The FDA Commissioner also stated, "In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding. (wikipedia.org)