The Experts below are selected from a list of 285 Experts worldwide ranked by ideXlab platform
George Rochester - One of the best experts on this subject based on the ideXlab platform.
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recommendations for safety planning data Collection Evaluation and reporting during drug biologic and vaccine development a report of the safety planning Evaluation and reporting team
Clinical Trials, 2009Co-Authors: Brenda J Crowe, Hongliang Shi, Amy H Xia, Juergen Kuebler, Robert C Schriver, Douglas J Watson, Nancy C. Santanello, Stephen Lin, Jesse A. Berlin, George RochesterAbstract:Background The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America.Purpose SPERT’s goal was to propose a pharmaceutical industry standard for safety planning, data Collection, Evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period.Methods SPERT’s recommendations are based on our review of relevant literature and on consensus reached in our discussions.Results An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data Collection and study design. We describe a 3-tier system for signal detection and analysis of a...
Ghassan Alhassan - One of the best experts on this subject based on the ideXlab platform.
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fog water Collection Evaluation in asir region saudi arabia
Water Resources Management, 2009Co-Authors: Ghassan AlhassanAbstract:Based on the fact that water can be collected from fog under favorable topographical and atmospheric conditions. The small water droplets present in the fog precipitate when they come in contact with solid objects. The frequent fogs that occur in the southwestern region of Kingdom of Saudi Arabia have the potential to provide an alternative source of freshwater in this otherwise dry region if harvested through the use of simple and low-cost Collection systems known as fog collectors. A fog Collection project has been carried out in Asir region of Saudi Arabia. Three Standard Fog Collectors (SFC) were designed and manufactured with locally available materials and imported mesh. These SFCs were installed in April 2006. Three different sites were chosen based on topography and altitude and data from April 2006 to April 2007 were obtained. Measurements with the SFCs were made for regions with 2,260 to 3,200 m elevation. The results indicate that at highest altitudes (at Alsooda), it is feasible to obtain an average water production of 6.215 L/m 2 day over the studied period, and in the lower altitudes, which are in Abha city, it is possible to collect more than 3.3 L/m 2 day. The highest water Collection was 24 L/m 2 day and recorded in Dec. 20, 2006 at Al-Sahab park station, and furthermore for the same site, the best average water production of 11.5 L/m 2 day was obtained in winter 3 months period namely (December, November and January). Data about the weather conditions has been collected for the studied region. An analysis of fog Collection effectiveness was carried out and compared with international standards. The obtained results indicate that fog can be a useful source of water supply in the southwest region of Saudi Arabia. Copyright Springer Science+Business Media B.V. 2009
Ghassan A. Al-hassan - One of the best experts on this subject based on the ideXlab platform.
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Fog Water Collection Evaluation in Asir Region-Saudi Arabia
Water Resources Management, 2009Co-Authors: Ghassan A. Al-hassanAbstract:Based on the fact that water can be collected from fog under favorable topographical and atmospheric conditions. The small water droplets present in the fog precipitate when they come in contact with solid objects. The frequent fogs that occur in the southwestern region of Kingdom of Saudi Arabia have the potential to provide an alternative source of freshwater in this otherwise dry region if harvested through the use of simple and low-cost Collection systems known as fog collectors. A fog Collection project has been carried out in Asir region of Saudi Arabia. Three Standard Fog Collectors (SFC) were designed and manufactured with locally available materials and imported mesh. These SFCs were installed in April 2006. Three different sites were chosen based on topography and altitude and data from April 2006 to April 2007 were obtained. Measurements with the SFCs were made for regions with 2,260 to 3,200 m elevation. The results indicate that at highest altitudes (at Alsooda), it is feasible to obtain an average water production of 6.215 L/m2 day over the studied period, and in the lower altitudes, which are in Abha city, it is possible to collect more than 3.3 L/m2 day. The highest water Collection was 24 L/m2 day and recorded in Dec. 20, 2006 at Al-Sahab park station, and furthermore for the same site, the best average water production of 11.5 L/m2 day was obtained in winter 3 months period namely (December, November and January). Data about the weather conditions has been collected for the studied region. An analysis of fog Collection effectiveness was carried out and compared with international standards. The obtained results indicate that fog can be a useful source of water supply in the southwest region of Saudi Arabia.
Brenda J Crowe - One of the best experts on this subject based on the ideXlab platform.
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recommendations for safety planning data Collection Evaluation and reporting during drug biologic and vaccine development a report of the safety planning Evaluation and reporting team
Clinical Trials, 2009Co-Authors: Brenda J Crowe, Hongliang Shi, Amy H Xia, Juergen Kuebler, Robert C Schriver, Douglas J Watson, Nancy C. Santanello, Stephen Lin, Jesse A. Berlin, George RochesterAbstract:Background The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America.Purpose SPERT’s goal was to propose a pharmaceutical industry standard for safety planning, data Collection, Evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period.Methods SPERT’s recommendations are based on our review of relevant literature and on consensus reached in our discussions.Results An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data Collection and study design. We describe a 3-tier system for signal detection and analysis of a...
Hongliang Shi - One of the best experts on this subject based on the ideXlab platform.
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recommendations for safety planning data Collection Evaluation and reporting during drug biologic and vaccine development a report of the safety planning Evaluation and reporting team
Clinical Trials, 2009Co-Authors: Brenda J Crowe, Hongliang Shi, Amy H Xia, Juergen Kuebler, Robert C Schriver, Douglas J Watson, Nancy C. Santanello, Stephen Lin, Jesse A. Berlin, George RochesterAbstract:Background The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America.Purpose SPERT’s goal was to propose a pharmaceutical industry standard for safety planning, data Collection, Evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period.Methods SPERT’s recommendations are based on our review of relevant literature and on consensus reached in our discussions.Results An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data Collection and study design. We describe a 3-tier system for signal detection and analysis of a...