Search Results - "Abadie, E."

Diabetes clinical trials: helped or hindered by the current shift in regulatory requirements? by ZANNAD, Faiez, STOUGH, Wendy Gattis, ABADIE, Eric, ALONSO-GARCIA, Angeles, PITT, Bertram, POCOCK, Stuart J, SLEIGHT, Peter, CUSHMAN, William C, CLELAND, John G. F, MCMURRAY, John J. V, LONN, Eva, GELLER, Nancy L, WEDEL, Hans

“…Glycaemic control is an inadequate surrogate marker of cardiovascular event reduction in patients with type 2 diabetes. Clinical trials to date have been…”
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Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval by Eichler, H‐G, Oye, K, Baird, L G, Abadie, E, Brown, J, Drum, C L, Ferguson, J, Garner, S, Honig, P, Hukkelhoven, M, Lim, J C W, Lim, R, Lumpkin, M M, Neil, G, O'Rourke, B, Pezalla, E, Shoda, D, Seyfert‐Margolis, V, Sigal, E V, Sobotka, J, Tan, D, Unger, T F, Hirsch, G

“…Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a…”
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Rosiglitazone: a European regulatory perspective by Blind, E, Dunder, K, de Graeff, P. A, Abadie, E

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What are the main environmental factors driving the development of the neurotoxic dinoflagellate Vulcanodinium rugosum in a Mediterranean ecosystem (Ingril lagoon, France)? by Abadie, Eric, Chiantella, Claude, Crottier, Anaïs, Rhodes, Lesley, Masseret, Estelle, Berteaux, Tom, Laabir, Mohamed

“…•Results indicated that temperature was the key factor influencing cell concentrations of V. rugosum and the development periods in this ecosystem.•V. rugosum…”
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Response of diatom and dinoflagellate lifeforms to reduced phosphorus loading: A case study in the Thau lagoon, France by Gowen, R.J., Collos, Y., Tett, P., Scherer, C., Bec, B., Abadie, E., Allen, M., O'Brien, T.

“…The basin of Thau in southern France is a shallow, weakly flushed lagoon which is an important location for oyster cultivation. Phytoplankton analyses were…”
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Biomarkers and personalised medicine in rheumatoid arthritis: a proposal for interactions between academia, industry and regulatory bodies by Miossec, P, Verweij, C L, Klareskog, L, Pitzalis, C, Barton, A, Lekkerkerker, F, Reiter, S, Laslop, A, Breedveld, F, Abadie, E, Flamion, B, Dere, W, Mpofu, S, Goel, N, Ethgen, D, Mitlak, B, Ormarsdóttir, S, Rao, R, Tsouderos, Y, Reginster, J-Y

“…Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been…”
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10. Extended evaluation of mixed-mode and lipophilic sorbents for passive sampling of marine toxins by Zendong, Z., Brissard, C., Herrenknecht, C., Tixier, C., Abadie, E., Mondeguer, F., Sechet, V., Amzil, Z., Hess, P.

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need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES) by Bruyere, O, Kanis, J. A, Ibar-Abadie, M.-E, Alsayed, N, Brandi, M. L, Burlet, N, Cahall, D. L, Chines, A, Devogelaer, J.-P, Dere, W, Goel, N, Hughes, N, Kaufman, J.-M, Korte, S, Mitlak, B. H, Niese, D, Rizzoli, R, Rovati, L. C, Reginster, J.-Y

“…Summary This paper provides recommendations for fair and unbiased relationship between academic scientists and the pharmaceutical industry. Introduction Real…”
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Cellular models and cytotoxicity of pinnatoxin-G and extracts of the dinoflagellate Vulcanodinium rugosum recently isolated from the French mediterranean lagoon of Ingril by Geiger, M., Deslanglois, G., Hogeveen, K., Fessard, V., Abadie, E., Leprêtre, T., Hervé, F., Séchet, V., Aráoz, R., Molgó, J., Grovel, O., Pouchus, Y.F., Hess, P.

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Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis by Altman, R.D., Abadie, E., Avouac, B., Bouvenot, G., Branco, J., Bruyere, O., Calvo, G., Devogelaer, J.-P., Dreiser, R.L., Herrero-Beaumont, G., Kahan, A., Kreutz, G., Laslop, A., Lemmel, E.M., Menkes, C.J., Pavelka, K., Van De Putte, L., Vanhaelst, L., Reginster, J.-Y.

“…The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential…”
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Metabolic Syndrome, New Onset Diabetes, and New End points in Cardiovascular Trials by Haffner, Steve M., Ruilope, Luis, Dahlöf, Björn, Abadie, Eric, Kupfer, Stuart, Zannad, Faiez

“…Metabolic syndrome affects approximately 44% of the US population over the age of 50 years. Although conflicting definitions exist, the syndrome is typically…”
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European regulatory perspectives for innovative therapies by Ormarsdottir, S., Reginster, J.-Y., Abadie, E.

“…The current regulatory requirements offer accelerated assessment of innovative therapies in Europe. Future perspectives include the need for increased…”
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Uncertain future of trials in osteoporosis by KANIS, J. A, ODEN, A, JOHNELL, O, CAULIN, F, BONE, H, ALEXANDRE, J.-M, ABADIE, E, LEKKERKERKER, F

“…The advent of effective agents for the treatment of osteoporosis has led to the view that placebo-controlled trials to test new agents for efficacy are no…”
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Renal Fanconi syndrome with meropenem/amoxicillin-clavulanate during treatment of extensively drug-resistant tuberculosis by Abadie, Miriam E, Strich, Jeffrey R, Kim, Tiffany, Xie, Yingda L, Fennelly, Kevin P, Olivier, Kenneth N, Waldman, Meryl, Arora, Kriti, Holland, Steven M, Chen, Ray Y

“…We read with interest the papers by Tiberi et al. [1, 2] describing the effectiveness of meropenem/clavulanate in treating multidrug-resistant (MDR) and…”
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Recurrent Selection for Partial Resistance to Crown Rust in Oat by Díaz‐Lago, Juan E., Stuthman, Deon D., Abadie, Tabaré E.

“…Crown rust (caused by the fungus Puccinia coronata Cda. f. sp. avenae Eriks.) is a major disease of cultivated oat (Avena sativa L.). Partial resistance is a…”
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Background for studies on the treatment of male osteoporosis: state of the art by Kaufman, J M, Johnell, O, Abadie, E, Adami, S, Audran, M, Avouac, B, Sedrine, W Ben, Calvo, G, Devogelaer, J P, Fuchs, V, Kreutz, G, Nilsson, P, Pols, H, Ringe, J, Van Haelst, L, Reginster, J Y

“…Male osteoporosis represents an important, although long underestimated, public health problem. Both in men and in women aging is accompanied by continuous…”
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Study Design in Osteoporosis: A European Perspective by Kanis, Ja, Alexandre, J‐M, Bone, Hg, Abadie, E, Brasseur, D, Chassany, O, Durrleman, S, Lekkerkerker, Jff, Caulin, F

“…The advent of effective agents for the treatment of osteoporosis has led to the view that placebo‐controlled trials to test new agents for efficacy are no…”
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The use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis by Delmas, P D, Calvo, G, Boers, M, Abadie, E, Avouac, B, Kahan, A, Kaufman, J M, Laslop, A, Lekkerkerker, J F, Nilsson, P, Van Zwieten-Boot, B, Kreutz, G, Reginster, J Y

“…Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with…”
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Variation in Health Technology Assessment and Reimbursement Processes in Europe by Akehurst, Ronald L, BSc, DSc, Abadie, Eric, MD, MBA, Renaudin, Noël, Sarkozy, François, MD

“…Abstract Background It has been suggested that differences in health technology assessment (HTA) processes among countries, particularly within Europe, have…”
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Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain by DEVOGELAER, J.-P, DREISER, R.-L, RICHY, F, ROZENBERG, S, TAVARES, V, VALAT, J. P, REGINSTER, J. Y, ABADIE, E, AVOUAC, B, BOUVENOT, G, ABELLO, J. Carbonell, KAUFMAN, J. M, KOES, B. W, LASLOP, A, LEMRNEL, E

“…In this paper we propose guidelines for clinical trials aimed at assessing the efficacy of drugs for acute non-specific low back pain (LBP) with or without…”
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