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Select Preservation Resources - Shocking Statistics: Reasons for Preservation Week: Facts that illustrate the need for national preservation awareness. - PW Fact Sheet: More facts that discusses how items become damaged and simple steps to keep them safe. - Preserving Your Memories: Organized by material type, these web sites, books, and other sources give useful information on caring for any |
kind of collection. - Disaster Recovery: Information for before and after a disaster has damaged precious collections. - Bibliographies & Indexes: A list of links to resources collected by professional preservation organizations - Videos: Video resources depict ways and reasons to preserve collections - Preservation for Children: Tools to help children understand the importance of preservation. - Comprehensive Resources - |
Resources in Other Languages: Spanish, French, Chinese, Italian, and Arabic resources for spreading the preservation message. - Books of Fiction about Conservation - Books of Fiction about Books for Book Groups |
In preparation for Christmas, I read Stephen Nissenbaum's 1998 "The Battle for Christmas," a thorough exploration of this season. The book's title will be deceiving, because it has nothing to do with the recent sacred-vs.-secular Christmas quarrels. Nissenbaum explores the myriad ways that Christmas has evolved in our nation. It turns out we've been jockeying for more than 300 years |
over what this holiday means. In Colonial America our faith-filled ancestors banned Christmas altogether, outlawing it in some colonies. Until the 1760s, one could not even find an almanac that would print the word "Christmas" on the date Dec. 25. This opposition was because Christmas had become a drunken spectacle where gangs of poor young men roamed the streets, making |
merry and engaging in acts of petty rowdyism, vaguely like today's New Year's Eve. It was customary and permissible for these gangs to knock on doors of strangers to demand gifts. ("So give us some figgy pudding....") Our nation's first "battle" for Christmas was the movement to domesticate the holiday, a battle that Nissenbaum suggests involved merchants, the middle and |
upper classes and the church. Merchants began linking Christmas and the purchase of manufactured gifts as early as the 1830s as society began to stress family celebrations in front of a tree and with Santa visiting every home. In case you think that your complaining will reverse the commercialism of this holiday, according to Nissenbaum that complaint first emerged in |
the 1830s. Complain if you must, but don't expect results. Nissenbaum so thoroughly explores Clement Moore's "'Twas the Night before Christmas" that one learns why Saint Nick touches the side of his nose and why his pipe is a short one. Nissenbaum contends that the ascendance of Santa Claus, the emergence of the Christmas tree and even the giving of |
gifts contribute to this gradual process of making Christmas a less revolutionary, more predictable holiday. He explores Dickens and Scrooge, Christmas parties for poor children and even the complicated master-slave relationship at Christmas leading up to and immediately following the Civil War. If you prefer to maintain that Christmas was a pure season of private devotion and public worship until |
Sears, Roebuck, Wal-Mart and the Supreme Court got involved, don't read this book. Ditto if you enjoy lamenting that "They've taken Christmas away from us," Nissenbaum might say that a pure, simple Christmas never existed. Rather it has evolved since the first day the Colonists set foot on our shore, an evolution showing no sign of abating. Nissenbaum's scholarly, heavily |
footnoted book is enlightening and readable. But his analysis of Christmas reminds me of a scientist who thoroughly explains the rainbow but never grasps its beauty. And so as this season continues to evolve, I'll enjoy my Christmas tree, sing both "White Christmas" and "Joy to the World," and be grateful again for the mystery of Bethlehem, which properly understood, |
Heal Our Planet Earth Secondary and Universities Educational Outreach: Secondary (High) Schools and Universities Anthony Marr from the HOPE Foundation’s main point was the wild tigers. He believes that something must be done to keep these animals alive. "If we let this go, life will be less beautiful and worth |
less living," Anthony Marr quoted. The money that he receives as a conservationist is donated to help out the endangered species. He makes many trips to India to help them find other solutions to their problems. If the people living in India keep living the way they’ve done, India will |
soon become a desert. Changes need to be made and people need to adapt to these changes. I agree with Anthony’s beliefs. Even if tigers are bred, it does not make a difference, because they cannot survive on their own. No matter what humans do, it still will not change |
the fact that one of God’s creations is becoming destroyed. No animals should be killed for the purpose of human needs. It is not necessary to kill tigers to sell products and make money because of silly beliefs that of they eat this then something will happen. There are so |
many alternatives. Humans need food, but they do not have to consume so much meat. Every time they eat meat, a precious animal is being killed. Animals do not kill us and eat us, then why should we do the same? More solutions need to be found and more people |
Science Fair Project Encyclopedia The chloride ion is formed when the element chlorine picks up one electron to form the anion (negatively charged ion) Cl−. The salts of hydrochloric acid |
HCl contain chloride ions and are also called chlorides. An example is table salt, which is sodium chloride with the chemical formula NaCl. In water, it dissolves into Na+ and |
Cl− ions. The word chloride can also refer to a chemical compound in which one or more chlorine atoms are covalently bonded in the molecule. This means that chlorides can |
be either inorganic or organic compounds. The simplest example of an inorganic covalently bonded chloride is hydrogen chloride, HCl. A simple example of an organic covalently bonded chloride is chloromethane |
(CH3Cl), often called methyl chloride. Other examples of inorganic covalently bonded chlorides which are used as reactants are: - phosphorus trichloride, phosphorus pentachloride, and thionyl chloride - all three are |
reactive chlorinating reagents which have been used in a laboratory. - Disulfur dichloride (SCl2) - used for vulcanization of rubber. Chloride ions have important physiological roles. For instance, in the |
central nervous system the inhibitory action of glycine and some of the action of GABA relies on the entry of Cl− into specific neurons. The contents of this article is |
Science Fair Project Encyclopedia Industrial Design is an applied art whereby the aesthetics and usability of products may be improved. Design aspects specified by the industrial designer may include the overall shape of the object, the location of details with respect to one another, colors, texture, sounds, and aspects concerning |
the use of the product ergonomics. Additionally the industrial designer may specify aspects concerning the production process, choice of materials and the way the product is presented to the consumer at the point of sale. The use of industrial designers in a product development process may lead to added values |
by improved usability, lowered production costs and more appealing products. Product Design is focused on products only, while industrial design has a broader focus on concepts, products and processes. In addition to considering aesthetics, usability, and ergonomics, it can also encompass the engineering of objects, usefulness as well as usability, |
market placement, and other concerns. Product Design and Industrial Design can overlap into the fields of user interface design , information design and interaction design. Various schools of Industrial Design and/or Product Design may specialize in one of these aspects, ranging from pure art colleges (product styling) to mixed programs |
of engineering and design, to related disciplines like exhibit design and interior design. In the US, the field of industrial design hit a high-water mark of popularity in the late 30's and early 40's, with several industrial designers becoming minor celebrities. Raymond Loewy, Norman bel Geddes, and Henry Dreyfuss remain |
the best known. In the UK, the term "Industrial Design" increasingly implies design with considerable engineering and technology awareness alongside human factors - a "Total Design" approach, promoted by the late Stuart Pugh (University of Strathclyde) and others. Famous industrial designers - Egmont Arens (1888-1966) - Norman bel Geddes (1893-1958) |
- Henry Dreyfuss (1904-1972) - Charles and Ray Eames (1907-1978) and (1912-1988) - Harley J. Earl (1893-1969) - Virgil Exner (1909-1973) - Buckminster Fuller (1895-1983) - Kenneth Grange (1929- ) - Michael Graves (1934- ) - Walter Adolph Gropius (1883-1969) - Jonathan Ive (1967- ) - Arne Jacobsen (1902-1971) - |
Raymond Loewy (1893-1986) - Ludwig Mies van der Rohe (1886-1969) - László Moholy-Nagy (1895-1946) - Victor Papanek (1927-1999) - Philippe Starck (1949- ) - Brooks Stevens (1911-1995) - Walter Dorwin Teague (1883-1960) - Eva Zeisel (1906- ) - Industrial design rights - Design classics - Interaction Design - Automobile design |
- Six Sigma - Famous Industrial Designers - Design Council on Product Design Design Council one stop shop information resource on Product Design by Dick Powell. - Industrial Designers Society of America - The Centre for Sustainable Design - International Council of Societies of Industrial Designers - U.S. Occupational Outlook |
Help kids practice their counting skills with this printable counting to eight (8) worksheet that has a fun birds theme. This worksheet will be a great addition to any numbers or counting lesson plan as well as any birds themed lesson plan. On this worksheet, kids are asked to count |
the number of cardinals and circle the correct number (eight) at the bottom of the page. View and Print Your Birds Themed Counting Worksheet All worksheets on this site were done personally by our family. Please do not reproduce any of our content on your own site without direct permission. |
Dr. Carl Auer von Welsbach (1858-1929) had a rare double talent of understanding how to pursue fundamental science and, at the same time, of commercializing himself successfully as a inventor and discoverer. He discovered 4 elements (Neodymium, Praseodymium, Ytterbium, and Lutetium). He invented the incandescent mantle, that helped gaslighting at the end of the 19th century to a renaissance. He developed the Ferrocerium - |
it`s still used as a flint in every disposable lighter. He was an eminent authority, and great expert in the field of rare earths (lanthanoides). He invented the electric metal filament light bulb which is used billions of times today. Additionally, all his life he took active part in different fields, from photography to ornithology. His personal qualities are remembered highly by the people |
of Althofen, he not only had an excellent mind but also a big heart. These qualities ensured him a prominent and lasting place not only in Austria`s science and industrial history. 9th of Sept. 1858: Born in Vienna, son of Therese and Alois Ritter Auer von Welsbach ( his father was director of the Imperial printing office the "Staatsdruckerei"). 1869-73: went to the secondary |
school in Mariahilf, (then changed to the secondary school in Josefstadt.) 1873-77: went to secondary school in Josefstadt, graduation. 1877-78: military service, became a second lieutenant. 1878-80: Inscribed into the technical University of Vienna; studies in math, general organic and inorganic chemistry, technical physics and thermodynamics with the Professors Winkler, Bauer, Reitlinger; and Pierre. 1880-82: Changed to the University of Heidelberg; lectures on inorganic |
experimental chemistry and Lab. experiments with Prof. Bunsen, introduction to spectral analysis and the history of chemistry, mineralogy and physics. 5th of Feb. 1882: Promotion to Doctor of Philosophy at the Ruperta-Carola-University in Heidelberg. 1882: Return to Vienna as unpaid Assistant in Prof. Lieben`s laboratory; work with chemical separation methods for investigations on rare earth elements. 1882-1884: Publications: " Ueber die Erden des Gadolinits |
von Ytterby", "Ueber die Seltenen Erden". 1885: The first separation of the element "Didymium" with help from a newly developed separation method from himself, based on the fractioned crystalisation of a Didym-ammonium nitrat solution. After the characteristical colouring, Auer gave the green components the name Praseodymium, the pink components the name Neodidymium. In time the latter element was more commonly known as Neodymium. 1885-1892: |
Work on gas mantle for the incandescent lighting. Development of a method to produce gas mantle ("Auerlicht) based on the impregnation from cottontissue by means, measures, methods of liquids, that rare earth has been absolved in and the ash from the material in a following glow process. Production of the first incandescent mantle out of lanthanum oxide, in which the gas flame is surrounded |
from a stocking; definite improvement in light emmission, but lack of stability in humidity. Continuous improvements in the chemical composition of the incandescent mantel "Auerlicht", experimentations of Lanthanum oxide-magnesium oxide- variations. 18th of Sept. 1885: The patenting of a gas burner with a "Actinophor" incandescent mantle made up of 60% magnesium oxide, 20% lanthanum oxide and 20% yttrium oxide; in the same year, the |
magnesium oxide part was replaced with zirconium oxide and the constitution of a second patent with reference to the additional use of the light body in a spirits flame. 9th of April 1886: Introduction the name "Gasgluehlicht" through the Journalist Motiz Szeps after the successful presentation from the Actinophors in the lower Austrian trade union ; regular production of the impregnation liquid, called "Fluid", |
at the Chemical Institute. 1887: The acquisition of the factory Würth & Co. for chemical-pharmaceutical products in Atzgersdorf and the industrial production of the light bodies. 1889: The beginning of sales problems because of the defaults with the earlier incandescent mantle, ie. it`s fragility, the short length of use, as well as having an unpleasant, cold, green coloured light , and the relatively high |
price. The factory in Atzgersdorf closes. The development of fractioned cristallisation methods for the preparation of pure Thorium oxide from and therefore cheap Monazitsand. The analysis of the connection between the purity of Thorium oxide and its light emission. The ascertainment of the optimal composition of the incandescent mantle in a long series of tests. 1891: Patenting of the incandescent mantle out of 99% |
Thorium oxide and 1% Cerium oxide, at that period of time, because of the light emission it was a direct competition for the electric carbon-filament lamp. The resuming of production in Atzgersdorf near Vienna and the quick spreading of the incandescent mantle because of their high duration. The beginning of a competition with the electric lighting. Work with high melting heavy metals to improve |
and higher the filament temperature, and therefore the light emission as well. The development of the production of thin filaments. The making of incandescent mantle with Platinum threads that were covered with high melting Thorium oxide, whereby it was possible to use the lamps over the melting temperature of Platinum. This variation was discarded because with smelting the platinum threads either the cover would |
burst or by solidifying it would rip apart. The taking out of a patent for two manufacturing methods for filaments. In the patent specification Carl Auer von Welsbach described the manufacturing of filaments through secretion of the high smelting element Osmium onto the metallic-filament. The development and experimentation of further designing methods such as the pasting method for the manufacturing of suitable high smelting |
metallic-filaments. With this method Osmium powder and a mixture of rubber or sugar is mixed together and kneaded into a paste. The manufacturing results in that the paste gets stamped through a delicate nozzle discharged cylinder and the filament subsequently dries and sinters. This was the first commercial and industrial process in the powder metallurgy for very high smelting metals. 1898: The acquiring of |
a industrial property in Treibach and the beginning of the experimentation and discovery work at this location. The taking out of a patent for the metallic-filament lamp with Osmium filament. 1899: Married Marie Nimpfer in Helgoland. 1902: Market introduction of the "Auer-Oslight" the first industrial finished Osmium metallic-filament lamp using the paste method. The advantages of this metallic-filament lamp over the, at that period |
of time, widely used carbon-filament lamp were: 57% less electricity consumption; less blackening of the glass; because of the higher filament temperature, a "whiter" light; a longer life span and therefore more economic. The beginning of the investigation of spark giving metals with the aim ignition mechanisms for lighters, gas lighters and gas lamps as well as projectile and mine ignition. Carl Auer von |
Welsbach knew of the possibility to produce sparks by mechanical means from Cerium from his teacher Prof. Bunsen. The ascertainment of the optimal compound from Cerium-Iron alloys for spark production. 1903: The taking out of a patent for his pyrophoric alloys (by scratching with hard and sharp surfaces a splinter which could ignite itself.) In the patent specification 70% Cerium and 30% Iron was |
given as an optimal compound. Further development of a method to produce the latter alloy cheaply. The optimizing of Bunsen, Hillebrand and Norton´s procedure, used at that time mainly for producing Cerium, was based on the fusion electrolysis from smelted Rare Earth chlorides. The problem at that time was in the leading of the electrolysis to secrete a pore-free and long lasting metal. This |
was the first industrial process and commercial utilization of the rare earth metals. 30th of March 1905: A report to the "Akademie der Wissenschaften" in Vienna that the results of the spectroscopic analysis show that Ytterbium is made up of two elements. Auer named the elements after the stars Aldebaranium and Cassiopeium. He ommitted the publication of the attained spectras and the ascertained atomic |
weights. 1907: The founding of the "Treibacher Chemische Werke GesmbH" in Treibach-Althofen for the production of Ferrocerium- lighter flints under the trade name "Original Auermetall". The publication of the spectras and the atomic weights of both new, from Ytterbium separated elements, in the completion of his report to the Academie der Wissenschaften. Priority dispute with the french Chemist Urbain concerning the analysis of Ytterbium. |
1908: The solution of the electrolysis of fused salts (cerium chloride) problem, at which the minerals Cerit and Allanite are used as source substances. 1909: The adaption of the procedure, from his collaborator, Dr.Fattinger, to be able to use the Monazitsand residue out of the incandescent mantle production, for the production of cerium metal for the lighter flints. The production of three different pyrophoric |
alloys: "Cer" or Auermetall I : Alloy out of fairly pure Cerium and Iron. Used for igniting purposes. "Lanthan" or Auermetall II : The Cerium-Iron alloy enriched with the element Lanthan. Used for light signals because of its particularly bright sparking power. Erdmetall or Auermetall III : Alloy out of Iron and "natural" Cermischmetall; a rare earth metal alloy of corresponding natural deposits. Both |
of the first alloys could not win its way through the market. only the easy to produce Erdmetall, after the renaming it Auermetall I, obtained world wide status as the flint in the lighter industry. 1909: The International Atomic weight Commission decided in favour of Urbain´s publication instead of Auer´s because Urbain handed it in earlier. The Commission of the term from Urbain Neoytterbium- |
known today as Ytterbium and Lutetium for the new elements. The carrying-out of large scale chemical separations in the field of radioactive substances. The production of different preparations of Uran, Ionium (known today as Th230 isotop), a disintegration product in the Uranium-Radium-line, Polonium and Aktinium, that Auer made available, for research use, to such renowned Institutions and scientists as F.W.Aston and Ernest Rutherford at |
the Cavendish Laboratory in Cambridge (1921) and the "Radiuminstitut der Akademie der Wissenschaften" in Vienna. 1922: A report on his spectroscopic discoveries to the "Akademie der Wissenschaften" in Vienna. 1929:World-wide production of ligther flints reached 100,000 kg. 8th of April 1929: Carl Auer von Welsbach died at the age of 70. |
Ethics of dementia research What are clinical trials and how are they controlled/governed? A clinical trial is a biomedical/health-related study into the effects on humans of a new medical treatment (medicine/drug, medical device, vaccine or new therapy), sometimes called an investigational medicinal product (IMP). Before a new drug is authorised |
and can be marketed, it must pass through several phases of development including trial phases in which its safety, efficacy, risks, optimal use and/or benefits are tested on human beings. Existing drugs must also undergo clinical testing before they can be used to treat other conditions than that for which |
they were originally intended. Organisations conducting clinical trials in the European Union must, if they wish to obtain marketing authorisation, respect the requirements for the conduct of clinical trials. These can be found in the Clinical Trials Directive (“Directive 2001/20/EC of the European Parliament and of the Council of 4 |
April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use”). There are also guidelines to ensure that clinical trials are carried out in accordance |
with good clinical practice. These are contained in the “Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products” (also |
known as the Good Clinical Practice or GCP for short). This document provides more concrete guidelines and lends further support to the Clinical Trials Directive. The London-based European Medicines Agency (EMA) has published additional, more specific guidelines which must also be respected. These include guidelines on inspection procedures and requirements |
Biomedicine (Oviedo Convention, Act 2619/1998), - the Additional protocol to the Oviedo Convention concerning Biomedical Research - the Nuremberg Code of 1949, - the revised Helsinki Declaration of the World Medical Association regarding Ethical Principles for Medical Research Involving Human Subjects, - The Belmont Report of 18 April 1979 on |
the Ethical Principles and Guidelines for the Protection of Human Subjects of Research. What are the different phases of trials? Testing an experimental drug or medical procedure is usually an extremely lengthy process, sometimes lasting several years. The overall procedure is divided into a series of stages (known as phases) |
which are described below. Clinical testing on humans can only begin after a pre-clinical phase, involving laboratory studies (in vitro) and tests on animals, which has shown that the experimental drug is considered safe and effective. Whilst a certain amount of testing can be carried out by means of computer |
modelling and by isolating cells and tissue, it becomes necessary at some point in time to test the drug on a living creature. Animal testing is an obligatory stage in the process of obtaining regulatory approval for new drugs and medicines, and hence a legal requirement (EU Directive 2001/83/EC relating |
to Medicinal Products for Human Use). The necessity of carrying out prior testing on animals is also stated in the World Medical Association’s “Ethical Principles for Medical Research Involving Human Subjects. In order to protect the well-being of research animals, researchers are guided by three principles which are called the |
3Rs: Reduce the number of animals used to a minimum Refine the way that experiments are carried out so that the effect on the animal is minimised and animal welfare is improved Replace animal experiments with alternative (non-animal) techniques wherever possible. In addition, most countries will have official regulatory bodies |
which control animal research. Most animals involved in research are mice. However, no animal is sufficiently similar to humans (even genetically modified ones) to make human testing unnecessary. For this reason, the experimental drug must also be tested on humans. The main phases of clinical trials Clinical trials on humans |
can be divided into three main phases (literally, phase I, II and III). Each phase has specific objectives (please see below) and the number of people involved increases as the trial progresses from one phase to the next. Phase I trials Phase 1 trials are usually the first step in |
testing a new drug or treatment on humans after successful laboratory and animal testing. They are usually quite small scale and usually involve healthy subjects or sub-groups of patients who share a particular characteristic. The aims of these trials are: - to assess the safety of experimental drugs, - to |
evaluate any possible side effects, - to determine a safe dose range, - to see how the body reacts to the drug (how it is absorbed, distributed and eliminated from the body, the effects that it has on the body and the effects it has on biomarkers). Dose ranging, sometimes |
called dose escalation, studies may be used as a means to determine the most appropriate dosage, but the doses administered to the subjects should only be a fraction of those which were found to cause harm to animals in the pre-clinical studies. The process of determining an optimal dose in |
phase I involves quite a high degree of risk because this is the first time that the experimental treatment or drug has been administered to humans. Moreover, healthy people’s reactions to drugs may be different to those of the target patient group. For this reason, drugs which are considered to |
have a potentially high toxicity are usually tested on people from the target patient group. There are a few sequential approaches to phase I trials e.g. single ascending dose studies, multiple ascending dose studies and food effect. In single ascending dose studies (SAD), a small group of subjects receive a |
very low dose of the experimental drug and are then observed in order to see whether that dose results in side effects. For this reason, trials are usually conducted in hospital settings. If no adverse side effects are observed, a second group of subjects are given a slightly higher dose |
of the same drug and also monitored for side-effects. This process is repeated until a dose is reached which results in intolerable side effects. This is defined as the maximum tolerated dose (MTD). Multiple ascending dose studies (MAD) are designed to test the pharmacokinetics and pharmacodynamics of multiple doses of |
the experimental drug. A group of subjects receives multiple doses of the drug, starting at the lowest dose and working up to a pre-determined level. At various times during the period of administration of the drug, and particularly whenever the dose is increased, samples of blood and other bodily fluids |
are taken. These samples are analysed in order to determine how the drug is processed within the body and how well it is tolerated by the body. Food effect studies are investigations into the effect of food intake on the absorption of the drug into the body. This involves two |
groups of subjects being given the same dose of the experimental drug but for one of the groups when fasting and for the other after a meal. Alternatively, this could be done in a cross-over design whereby both groups receive the experimental drug in both conditions in sequence (e.g. when |
fasting and on another occasion after a meal). Food effect studies allow researchers to see whether eating before the drug is given has any effect on the absorption of the drug by the body. Phase II trials Having demonstrated the initial safety of the drug (often on a relatively small |
sample of healthy individuals), phase II clinical trials can begin. Phase II studies are designed to explore the therapeutic efficacy of a treatment or drug in people who have the condition that the drug is intended to treat. They are sometimes called therapeutic exploratory trials and tend to be larger |
scale than Phase I trials. Phase II trials can be divided into Phase IIA and Phase IIB although sometimes they are combined. Phase IIA is designed to assess dosing requirements i.e. how much of the drug should patients receive and up to what dose is considered safe? The safety assessments |
carried out in Phase I can be repeated on a larger subject group. As more subjects are involved, some may experience side effects which none of the subjects in the Phase I experienced. The researchers aim to find out more about safety, side effects and how to manage them. Phase |
IIB studies focus on the efficacy of the drug i.e. how well it works at the prescribed doses. Researchers may also be interested in finding out which types of a specific disease or condition would be most suitable for treatment. Phase II trials can be randomised clinical trials which involve |
one group of subjects being given the experimental drug and others receiving a placebo and/or standard treatment. Alternatively, they may be case series which means that the drug’s safety and efficacy is tested in a selected group of patients. If the researchers have adequately demonstrated that the experimental drug (or |
device) is effective against the condition for which it is being tested, they can proceed to Phase III. Phase III trials Phase III trials are the last stage before clinical approval for a new drug or device. By this stage, there will be convincing evidence of the safety of the |
drug or device and its efficacy in treating people who have the condition for which it was developed. Such studies are carried out on a much larger scale than for the two previous phases and are often multinational. Several years may have passed since the original laboratory and animal testing. |
The main aims of Phase III trials are: to demonstrate that the treatment or drug is safe and effective for use in patients in the target group (i.e. in people for whom it is intended) to monitor side effects to test different doses or different ways of administering the drug |
to determine whether the drug could be used at different stages of the disease. to provide sufficient information as a basis for marketing approval Researchers may also be interested in showing that the experimental drug works for additional groups of people with conditions other than that for which the drug |
was initially developed. For example, they may be interested in testing a drug for inflammation on people with Alzheimer’s disease. The drug would have already have proven safe and obtained marketing approval but for a different condition, hence the need for additional clinical testing. Open label extension trails Open label |
extension studies are often carried out immediately after a double blind randomised clinical trial of an unlicensed drug. The aim of the extended study is to determine the safety and tolerability of the experimental drug over a longer period of time, which is generally longer than the initial trial and |
may extend up until the drug is licensed. Participants all receive the experimental drug irrespective of which arm of the previous trial they were in. Consequently, the study is no longer blind in that everybody knows that each participant is receiving the experimental drug but the participants and researchers still |
do not know which group participants were in during the initial trial. Post-marketing surveillance studies (phase IV) After the three phases of clinical testing and after the treatment has been approved for marketing, there may be a fourth phase to study the long-term effects of drugs or treatment or to |
study the impact of another factor in combination with the treatment (e.g. whether a particular drug reduces agitation). Usually, such trials are sponsored by pharmaceutical companies and described as pharmacovigilance. They are not as common as the other types of trials (as they are not necessary for marketing permission). However, |
in some cases, the EMA grants restricted or provisional marketing authorisation, which is dependent on additional phase IV trails being conducted. Expanded access to a trial Sometimes, a person might be likely to benefit from a drug which is at various stages of testing but does not fulfil the conditions |
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