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- Reginster, JY, et al.
(författare)
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Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men
- 2006
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Ingår i: Osteoporosis International. - : Springer Science and Business Media LLC. - 1433-2965 .- 0937-941X. ; 17:1, s. 41281-41281
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Recent advances in the understanding of the epidemiology of osteoporosis suggest that certain parts of the current European guidelines for the registration of drugs in osteoporosis might be no longer substantiated. The object of this review is to provide the European regulatory authorities with an evidence-based working document providing suggestions for the revision of the "Note for guidance for the approval of drugs to be used in postmenopausal osteoporosis" (CPMP/EWP/552/95). Following an extensive review of the literature (1990-2004), the Group for the Respect of Ethics and Excellence in Science (GREES) organized a workshop including European regulators, academic scientists and representatives of the pharmaceutical industry. The outcomes of this meeting reflect the personal views of those who attended and should not, in any case, be seen as an official position paper of any regulatory agency. The group identified a certain number of points that deserve discussion. They mainly relate to the nature of the indication being granted to new chemical entities (treatment of osteoporosis in women at high risk of fracture instead of prevention and treatment of osteoporosis), the requirements of showing an anti-fracture efficacy on all or on major nonvertebral fractures (instead of the hip), the duration of pivotal trials (2 years instead of 3) and the possibility of considering bridging studies for new routes of administration, new doses or new regimens of previously approved drugs. The group also recommends that an indication could be granted for the treatment of osteoporosis in males on the basis of a placebo-controlled study, with bone mineral density changes after 1 year as the primary endpoint, for medications approved in the treatment of osteoporosis in women at high risk of fractures.
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- Stenman, U H, et al.
(författare)
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Summary report of the TD-3 workshop: characterization of 83 antibodies against prostate-specific antigen
- 1999
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Ingår i: Tumor Biology. - : Springer Science and Business Media LLC. - 1423-0380 .- 1010-4283. ; 20:Suppl. 1, s. 1-12
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Tidskriftsartikel (refereegranskat)abstract
- Twelve research groups participated in the ISOBM TD-3 Workshop in which the reactivity and specificity of 83 antibodies against prostate-specific antigen (PSA) were investigated. Using a variety of techniques including cross-inhibition assays, Western blotting, BIAcore, immunoradiometric assays and immunohistochemistry, the antibodies were categorized into six major groups which formed the basis for mapping onto two- and three-dimensional (2-D and 3-D) models of PSA. The overall findings of the TD-3 Workshop are summarized in this report. In agreement with all participating groups, three main antigenic domains were identified: free PSA-specific epitopes located in or close to amino acids 86-91; discontinuous epitopes specific for PSA without human kallikrein (hK2) cross-reactivity located at or close to amino acids 158-163; and continuous or linear epitopes shared between PSA and hK2 located close to amino acids 3-11. In addition, several minor and partly overlapping domains were also identified. Clearly, the characterization of antibodies from this workshop and the location of their epitopes on the 3-D model of PSA illustrate the importance of selecting appropriate antibody pairs for use in immunoassays. It is hoped that these findings and the epitope nomenclature described in this TD-3 Workshop are used as a standard for future evaluation of anti-PSA antibodies.
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- Fisher, D., et al.
(författare)
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The Mt Logan Holocene-late Wisconsinan isotope record : Tropical Pacific-Yukon connections
- 2008
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Ingår i: Holocene. - : SAGE Publications. ; 18:5, s. 667-677
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Tidskriftsartikel (refereegranskat)abstract
- The ice core recovered from Prospector Russell Col on Mt Logan (5.4 km a.s.l.), in the Yukon spans over 20 000 years. This unique record offers a Pacific view of the stable isotope and chemical record from the Lateglacial to the present. The timescale is based on seasonal counted years, the largest known volcanic acid signatures and the major shift in stable isotopes and chemistry at the end of the Younger Dryas. There are large and sustained changes in the stable isotopic record that are anti-correlated with marine and continental chemistry series. The oxygen-18 in this area is not a proxy for palaeotemperature but rather for source region. The last major isotope shift in AD 1840 in δ(18O) and chemistry is compared with the Quinn's ENSO record. During periods of more frequent La Niña (stronger tropical easterlies) there is more zonal flow of water vapour transport to the Pacific Northwest, δ(18O) values are larger and the deuterium excess d smaller. These periods coincide with periods of lower accumulation/precipitation in southern Yukon. The Holocene δ(18O) record indicates many large shifts between the meridional (strong El Niño) and zonal (La Niña). Comparison of the Logan isotopic record and the moisture/temperature-sensitive time series of peat bog inception dates for the Northwest shows a strong correlation (0.36) that points to high accumulation rates coincident with low δ(18O) and enhanced meridional flow. Major changes in the core at 4200 BP and 7000—8000 BP point to enhanced meridional flow, which coincide with big changes in the Pacific palaeorecords of the balance between El Niño and La Niña. 4200 BP seems to have inaugurated the `modern' ENSO world.
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