The Experts below are selected from a list of 1484370 Experts worldwide ranked by ideXlab platform
Mitchell Klausner - One of the best experts on this subject based on the ideXlab platform.
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ensuring quality of in vitro alternative test methods current practice
Regulatory Toxicology and Pharmacology, 2006Co-Authors: Amy Rispin, Katherine A Stitzel, John W Harbell, Mitchell KlausnerAbstract:In Vitro toxicology methods are being validated and adopted by regulatory agencies for use as alternatives to animal testing. Such methods may use ex vivo tissues or bioconstructs, some of which may be proprietary. Users of the Data from these methods need to be reassured that the assays or assay components used in their studies provide consistent, good quality Data over Time, matching the standards achieved during the validation process. This paper presents an overview of approaches currently used by representatives of a manufacturer and a contract testing laboratory to ensure that the results from in vitro alternative methods are reproducible and of high quality over Time. These approaches include full characterization of cells or tissues, sampling of each lot of manufactured bioconstructs for performance, and regular use of controls and benchmark chemicals to provide assurance of consistency of assay performance.
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quality assurance for in vitro alternative test methods quality control issues in test kit production
Atla-alternatives To Laboratory Animals, 2004Co-Authors: Amy Rispin, John W Harbell, Mitchell Klausner, Foster T Jordan, Sandra Coecke, Kailash Gupta, Katherine StitzelAbstract:In vitro toxicology methods are being adopted by regulatory agencies worldwide. Many of these methods have been validated by using proprietary materials, often in the form of test kits. Guidelines for the use of Good Laboratory Practice methods for in vitro methods have been proposed. However, users of the Data from these methods also need to be reassured that the proprietary materials and the test kits will provide consistent, good quality Data over Time, not just during the validation process. This paper presents an overview of the methods currently used by representatives of kit manufacturers and contract testing laboratories to ensure that the results from methods that utilise test kits are reproducible over Time and across different types of test materials. This information will be valuable as a basis for future discussion on the need for formalised oversight of the quality of these materials.
Scarfi Simone - One of the best experts on this subject based on the ideXlab platform.
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First results from the CIC Data aggregation ASIC for the Phase 2 CMS Outer Tracker
'Sissa Medialab', 2020Co-Authors: Nodari Benedetta, Bergamin Gianmario, Caponetto Luigi, Caratelli Alessandro, Ceresa Davide, De Clercq Jarne, Galbit Geoffrey, Jain Sandhya, Kloukinas Kostas, Scarfi SimoneAbstract:The Concentrator Integrated Circuit (CIC) ASIC is a front-end chip for both Pixel-Strip (PS) and Strip-Strip (2S) modules of the future Phase 2 CMS Outer Tracker at the High-Luminosity LHC (HL-LHC). Prototyped in a 65 nm CMOS technology, the CIC aggregates the digital Data coming from eight upstream front-end chips, formatting it into Data packets containing the trigger information from eight bunch crossings and the raw Data from events passing the Level 1 (L1) trigger, before transmission to the lpGBT. The role of the CIC in the readout chain is to provide an extra factor of Data reduction by grouping Data over Time and space. A first prototype, the CIC1, integrating all functionalities for system level operation, has been tested in early 2019. A brief description of the functionalities and the test results obtained concerning the performance characterization and the radiation tolerance of the chip are presented in this contribution
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First results from the CIC Data aggregation ASIC for the Phase 2 CMS Outer Tracker
'Sissa Medialab', 2019Co-Authors: Nodari Benedetta, Bergamin Gianmario, Caponetto Luigi, Caratelli Alessandro, Ceresa Davide, De Clercq Jarne, Galbit Geoffrey, Jain Sandhya, Kloukinas Kostas, Scarfi SimoneAbstract:International audienceThe Concentrator Integrated Circuit (CIC) ASIC is a front-end chip for both Pixel-Strip (PS) and Strip-Strip (2S) modules of the future Phase 2 CMS Outer Tracker at the High-Luminosity LHC (HL-LHC). Prototyped in a 65 nm CMOS technology, the CIC aggregates the digital Data coming from eight upstream front-end chips, formatting it into Data packets containing the trigger information from eight bunch crossings and the raw Data from events passing the Level 1 (L1) trigger, before transmission to the lpGBT. The role of the CIC in the readout chain is to provide an extra factor of Data reduction by grouping Data over Time and space. A first prototype, the CIC1, integrating all functionalities for system level operation, has been tested in early 2019. A brief description of the functionalities and the test results obtained concerning the performance characterization and the radiation tolerance of the chip are presented in this contribution
Amy Rispin - One of the best experts on this subject based on the ideXlab platform.
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ensuring quality of in vitro alternative test methods current practice
Regulatory Toxicology and Pharmacology, 2006Co-Authors: Amy Rispin, Katherine A Stitzel, John W Harbell, Mitchell KlausnerAbstract:In Vitro toxicology methods are being validated and adopted by regulatory agencies for use as alternatives to animal testing. Such methods may use ex vivo tissues or bioconstructs, some of which may be proprietary. Users of the Data from these methods need to be reassured that the assays or assay components used in their studies provide consistent, good quality Data over Time, matching the standards achieved during the validation process. This paper presents an overview of approaches currently used by representatives of a manufacturer and a contract testing laboratory to ensure that the results from in vitro alternative methods are reproducible and of high quality over Time. These approaches include full characterization of cells or tissues, sampling of each lot of manufactured bioconstructs for performance, and regular use of controls and benchmark chemicals to provide assurance of consistency of assay performance.
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quality assurance for in vitro alternative test methods quality control issues in test kit production
Atla-alternatives To Laboratory Animals, 2004Co-Authors: Amy Rispin, John W Harbell, Mitchell Klausner, Foster T Jordan, Sandra Coecke, Kailash Gupta, Katherine StitzelAbstract:In vitro toxicology methods are being adopted by regulatory agencies worldwide. Many of these methods have been validated by using proprietary materials, often in the form of test kits. Guidelines for the use of Good Laboratory Practice methods for in vitro methods have been proposed. However, users of the Data from these methods also need to be reassured that the proprietary materials and the test kits will provide consistent, good quality Data over Time, not just during the validation process. This paper presents an overview of the methods currently used by representatives of kit manufacturers and contract testing laboratories to ensure that the results from methods that utilise test kits are reproducible over Time and across different types of test materials. This information will be valuable as a basis for future discussion on the need for formalised oversight of the quality of these materials.
Nodari Benedetta - One of the best experts on this subject based on the ideXlab platform.
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First results from the CIC Data aggregation ASIC for the Phase 2 CMS Outer Tracker
'Sissa Medialab', 2020Co-Authors: Nodari Benedetta, Bergamin Gianmario, Caponetto Luigi, Caratelli Alessandro, Ceresa Davide, De Clercq Jarne, Galbit Geoffrey, Jain Sandhya, Kloukinas Kostas, Scarfi SimoneAbstract:The Concentrator Integrated Circuit (CIC) ASIC is a front-end chip for both Pixel-Strip (PS) and Strip-Strip (2S) modules of the future Phase 2 CMS Outer Tracker at the High-Luminosity LHC (HL-LHC). Prototyped in a 65 nm CMOS technology, the CIC aggregates the digital Data coming from eight upstream front-end chips, formatting it into Data packets containing the trigger information from eight bunch crossings and the raw Data from events passing the Level 1 (L1) trigger, before transmission to the lpGBT. The role of the CIC in the readout chain is to provide an extra factor of Data reduction by grouping Data over Time and space. A first prototype, the CIC1, integrating all functionalities for system level operation, has been tested in early 2019. A brief description of the functionalities and the test results obtained concerning the performance characterization and the radiation tolerance of the chip are presented in this contribution
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First results from the CIC Data aggregation ASIC for the Phase 2 CMS Outer Tracker
'Sissa Medialab', 2019Co-Authors: Nodari Benedetta, Bergamin Gianmario, Caponetto Luigi, Caratelli Alessandro, Ceresa Davide, De Clercq Jarne, Galbit Geoffrey, Jain Sandhya, Kloukinas Kostas, Scarfi SimoneAbstract:International audienceThe Concentrator Integrated Circuit (CIC) ASIC is a front-end chip for both Pixel-Strip (PS) and Strip-Strip (2S) modules of the future Phase 2 CMS Outer Tracker at the High-Luminosity LHC (HL-LHC). Prototyped in a 65 nm CMOS technology, the CIC aggregates the digital Data coming from eight upstream front-end chips, formatting it into Data packets containing the trigger information from eight bunch crossings and the raw Data from events passing the Level 1 (L1) trigger, before transmission to the lpGBT. The role of the CIC in the readout chain is to provide an extra factor of Data reduction by grouping Data over Time and space. A first prototype, the CIC1, integrating all functionalities for system level operation, has been tested in early 2019. A brief description of the functionalities and the test results obtained concerning the performance characterization and the radiation tolerance of the chip are presented in this contribution
John W Harbell - One of the best experts on this subject based on the ideXlab platform.
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ensuring quality of in vitro alternative test methods current practice
Regulatory Toxicology and Pharmacology, 2006Co-Authors: Amy Rispin, Katherine A Stitzel, John W Harbell, Mitchell KlausnerAbstract:In Vitro toxicology methods are being validated and adopted by regulatory agencies for use as alternatives to animal testing. Such methods may use ex vivo tissues or bioconstructs, some of which may be proprietary. Users of the Data from these methods need to be reassured that the assays or assay components used in their studies provide consistent, good quality Data over Time, matching the standards achieved during the validation process. This paper presents an overview of approaches currently used by representatives of a manufacturer and a contract testing laboratory to ensure that the results from in vitro alternative methods are reproducible and of high quality over Time. These approaches include full characterization of cells or tissues, sampling of each lot of manufactured bioconstructs for performance, and regular use of controls and benchmark chemicals to provide assurance of consistency of assay performance.
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quality assurance for in vitro alternative test methods quality control issues in test kit production
Atla-alternatives To Laboratory Animals, 2004Co-Authors: Amy Rispin, John W Harbell, Mitchell Klausner, Foster T Jordan, Sandra Coecke, Kailash Gupta, Katherine StitzelAbstract:In vitro toxicology methods are being adopted by regulatory agencies worldwide. Many of these methods have been validated by using proprietary materials, often in the form of test kits. Guidelines for the use of Good Laboratory Practice methods for in vitro methods have been proposed. However, users of the Data from these methods also need to be reassured that the proprietary materials and the test kits will provide consistent, good quality Data over Time, not just during the validation process. This paper presents an overview of the methods currently used by representatives of kit manufacturers and contract testing laboratories to ensure that the results from methods that utilise test kits are reproducible over Time and across different types of test materials. This information will be valuable as a basis for future discussion on the need for formalised oversight of the quality of these materials.
