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Information investigations

It should always be remembered that the IB is not a promotional document aimed at presenting the NME in its best light on the contrary, it is intended to inform investigators and ethics committees about every aspect of the drug, to enable them to make wise judgements in the interest of study subjects, be they healthy volunteers or patients. The IB is necessarily a summary, but less than full disclosure of important information about the drug, whatever the source, is not acceptable and all documents should be referenced and made available on request. [Pg.152]

Whatever the length of detoxification, the issue of some symptomatic medication such as hypnotics at the very end can arise just as with methadone or dihydrocodeine, but there has been no informative investigation of this aspect. [Pg.73]

Protocols [ 312.23(a)(6)], protocol amendments [ 312.30], previous human experience [ 312.23(a)(9)], safety reports [ 312.32] and informational amendments related specifically to clinical [ 312.31] including adverse reactions, consent forms, investigator information, general investigational plan, Investigator s Brochures, IRB approval, new protocols, revised protocols, site information, investigator data, CVs, and 1572s... [Pg.105]

The MIAME standard defines the minimum information investigators must report for a microarray experiment to be reproduced. The MAGE standard was born partially from MIAME, and the European Bioinformatics Institute used MIAME and MAGE to guide the development of ArrayEx-press, their public genomic data repository (34). Sample annotation lies at the heart of MIAME, underscoring the need to understand as completely as possible the experimental conditions that may influence the microarray data. Many journals that publish microarray data require the submission of MIAME-supportive microarray data to a public genomic data repository as a condition of publication. These typically include submission of protocols species, strains, and sex used for in vivo studies cell line name and culture conditions for in vitro studies, and other relevant information. [Pg.534]

Just as the dimethylether-hydrogen chloride complex, this system yielded much useful information. Investigation of it started with Arnold and Millen s paper in 1965 20>. [Pg.57]

The overall policies of the particular manufacturing concern dictate the type and amount of insurance which will be held. It should be realized, however, that a well-designed insurance plan requires a great deal of skilled and informed investigation by persons who understand all the aspects of insurance as well as the problems involved in the manufacturing operation. [Pg.265]

C K. C Consult (Schleiden/Eifel, Germany) R. S. ChattY- technical information, investigations, and a photograph of a mobile air treatment system. [Pg.3]

Although interpretation In terms of surface pressures is relatively straightforward and informative. Investigators are unaccustomed to apply it to charged solid surfaces. In the mercury double layer field and with monolayers (Volume III) it is more common... [Pg.440]

In the course of some 40 years, we have accompanied cirrhotic patients for considerable periods of their lives, many for more than 10 years, some even for more than 15 years. This often resulted in experiences that modified and ultimately standardized our follow-up programme. Basic control parameters, i.e. parameters important in all forms of cirrhosis, are supplemented by more informative investigations (such as iron, copper or phosphatase values) in cases with a particular aetiology. Such a standard programme, which nevertheless leaves room for individual concepts, has proved successful over many years, (s. tab. 35.8)... [Pg.744]

Acquiring Information Investigate and describe how a solar furnace works. Is it an active or passive use of solar energy Explain your answer. [Pg.730]

Informing investigators The sponsor should give complete information to the investigators about the investigational drug. [Pg.1269]

Acquiring Information Investigate the role Pauling played in the discovery of the structure of DNA. [Pg.307]

Acquiring Information Investigate how ice cream is made at home. Relate the information gathered to the use of an antifreeze in an automobile during winter. [Pg.466]

Acquiring Information Investigate the lives and research of Robert Goddard and Werner Von Braun, who both experimented with rockets in the 1930s and helped guide the United States into the space age. Write a short report about these men. [Pg.566]

Acquiring Information Investigate and describe how a solar furnace works. [Pg.729]

In each case, an extensive, and informative investigation has been carried out on the solvation effects in ionic liquids [44],... [Pg.214]

Properties of interphases relevant for an understanding of structures and dynamics therein can be grouped into atomic (microscopic) and macroscopic ones. Nevertheless the close relationships between both types of properties have allowed us to infer conclusions with respect to atomic models from macroscopic information. Investigations of these properties have gained tremendously in recent years from the application of a broad variety of spectroscopic methods. Certainly many properties, in particular macroscopic ones, can be studied by measuring surface properties (like conductivity, hardness, etc.) with non-spectroscopic methods. In most cases the results will be rather general and a complete understanding of relationships between... [Pg.11]

The understanding of the electrode processes occurring is reliant on electrochemical data or on microscopic/spectroscopic information. In order to obtain further complementary, simultaneous information, investigations have begun with platinum or gold piezoelectric quartz crystals further coated with carbon [45]. [Pg.114]

Other than ex situ testing based on half-cell systems, in situ tests in full cells are conducted to further understand the durability issues for Pt-alloy based catalysts. Comparison of the results from different test systems can yield much useful information. Investigating the influence of carbon support corrosion, Pt dissolution, and sintering, Arico et al. (2008) evaluated the stability of Pt/C and Pt-Co/C in both a gas-fed sulfuric acid electrolyte half-cell at 75°C and a PEM fuel cell at 130°C. Results in sulfuric acid revealed the Pt-Co alloy to be more stable than Pt after cycling and more sensitive to carbon support corrosion. In high-temperature PEM fuel cell testing, Pt-Co/C showed smaller sintering effects than Pt/C. [Pg.21]

Type 1 Traditional, informal investigation performed by immediate supervisor... [Pg.102]

The purpose of these questions is not merely to request information but to structure and guide the thinking and activities of the technical specialists and operational personnel responsible for resolving a risk. So, even when requesting quite specific information, investigators frame their questions broadly. While their questions relate to specific and quite localised operational incidents, the queries are typically open-ended and question the general adequacy of safety in that area. For example, in one event an aircraft was landed with close to only the reserve amount of fuel left onboard. Investigators found it curious that,... [Pg.173]


See other pages where Information investigations is mentioned: [Pg.146]    [Pg.245]    [Pg.140]    [Pg.274]    [Pg.130]    [Pg.275]    [Pg.3]    [Pg.263]    [Pg.426]    [Pg.42]    [Pg.486]    [Pg.142]    [Pg.203]    [Pg.159]    [Pg.1606]    [Pg.299]    [Pg.134]    [Pg.143]   
See also in sourсe #XX -- [ Pg.336 ]




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