Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development
The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the con...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Brown, Lynette [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
2015transfer abstract |
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| Umfang: |
8 |
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| Übergeordnetes Werk: |
Enthalten in: 969: Cesarean prevalence rates overtime by maternal characteristics - Thompson, Jennifer A. ELSEVIER, 2018, JIM, Amsterdam [u.a.] |
|---|---|
| Übergeordnetes Werk: |
volume:418 ; year:2015 ; pages:1-8 ; extent:8 |
| Links: |
|---|
| DOI / URN: |
10.1016/j.jim.2015.01.008 |
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| 520 | |a The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. | ||
| 520 | |a The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. | ||
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| 700 | 1 | |a Stewart, Jennifer J. |4 oth | |
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| 700 | 1 | |a White, Wendy I. |4 oth | |
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10.1016/j.jim.2015.01.008 doi GBVA2015022000017.pica (DE-627)ELV024014982 (ELSEVIER)S0022-1759(15)00020-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 44.92 bkl Brown, Lynette verfasserin aut Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development 2015transfer abstract 8 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. Green, Cherie L. oth Jones, Nicholas oth Stewart, Jennifer J. oth Fraser, Stephanie oth Howell, Kathy oth Xu, Yuanxin oth Hill, Carla G. oth Wiwi, Christopher A. oth White, Wendy I. oth O'Brien, Peter J. oth Litwin, Virginia oth Enthalten in Elsevier Science Thompson, Jennifer A. ELSEVIER 969: Cesarean prevalence rates overtime by maternal characteristics 2018 JIM Amsterdam [u.a.] (DE-627)ELV001297813 volume:418 year:2015 pages:1-8 extent:8 https://doi.org/10.1016/j.jim.2015.01.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 44.92 Gynäkologie VZ AR 418 2015 1-8 8 045F 610 |
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10.1016/j.jim.2015.01.008 doi GBVA2015022000017.pica (DE-627)ELV024014982 (ELSEVIER)S0022-1759(15)00020-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 44.92 bkl Brown, Lynette verfasserin aut Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development 2015transfer abstract 8 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. Green, Cherie L. oth Jones, Nicholas oth Stewart, Jennifer J. oth Fraser, Stephanie oth Howell, Kathy oth Xu, Yuanxin oth Hill, Carla G. oth Wiwi, Christopher A. oth White, Wendy I. oth O'Brien, Peter J. oth Litwin, Virginia oth Enthalten in Elsevier Science Thompson, Jennifer A. ELSEVIER 969: Cesarean prevalence rates overtime by maternal characteristics 2018 JIM Amsterdam [u.a.] (DE-627)ELV001297813 volume:418 year:2015 pages:1-8 extent:8 https://doi.org/10.1016/j.jim.2015.01.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 44.92 Gynäkologie VZ AR 418 2015 1-8 8 045F 610 |
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10.1016/j.jim.2015.01.008 doi GBVA2015022000017.pica (DE-627)ELV024014982 (ELSEVIER)S0022-1759(15)00020-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 44.92 bkl Brown, Lynette verfasserin aut Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development 2015transfer abstract 8 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. Green, Cherie L. oth Jones, Nicholas oth Stewart, Jennifer J. oth Fraser, Stephanie oth Howell, Kathy oth Xu, Yuanxin oth Hill, Carla G. oth Wiwi, Christopher A. oth White, Wendy I. oth O'Brien, Peter J. oth Litwin, Virginia oth Enthalten in Elsevier Science Thompson, Jennifer A. ELSEVIER 969: Cesarean prevalence rates overtime by maternal characteristics 2018 JIM Amsterdam [u.a.] (DE-627)ELV001297813 volume:418 year:2015 pages:1-8 extent:8 https://doi.org/10.1016/j.jim.2015.01.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 44.92 Gynäkologie VZ AR 418 2015 1-8 8 045F 610 |
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10.1016/j.jim.2015.01.008 doi GBVA2015022000017.pica (DE-627)ELV024014982 (ELSEVIER)S0022-1759(15)00020-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 44.92 bkl Brown, Lynette verfasserin aut Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development 2015transfer abstract 8 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. Green, Cherie L. oth Jones, Nicholas oth Stewart, Jennifer J. oth Fraser, Stephanie oth Howell, Kathy oth Xu, Yuanxin oth Hill, Carla G. oth Wiwi, Christopher A. oth White, Wendy I. oth O'Brien, Peter J. oth Litwin, Virginia oth Enthalten in Elsevier Science Thompson, Jennifer A. ELSEVIER 969: Cesarean prevalence rates overtime by maternal characteristics 2018 JIM Amsterdam [u.a.] (DE-627)ELV001297813 volume:418 year:2015 pages:1-8 extent:8 https://doi.org/10.1016/j.jim.2015.01.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 44.92 Gynäkologie VZ AR 418 2015 1-8 8 045F 610 |
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10.1016/j.jim.2015.01.008 doi GBVA2015022000017.pica (DE-627)ELV024014982 (ELSEVIER)S0022-1759(15)00020-4 DE-627 ger DE-627 rakwb eng 610 610 DE-600 610 VZ 44.92 bkl Brown, Lynette verfasserin aut Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development 2015transfer abstract 8 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. Green, Cherie L. oth Jones, Nicholas oth Stewart, Jennifer J. oth Fraser, Stephanie oth Howell, Kathy oth Xu, Yuanxin oth Hill, Carla G. oth Wiwi, Christopher A. oth White, Wendy I. oth O'Brien, Peter J. oth Litwin, Virginia oth Enthalten in Elsevier Science Thompson, Jennifer A. ELSEVIER 969: Cesarean prevalence rates overtime by maternal characteristics 2018 JIM Amsterdam [u.a.] (DE-627)ELV001297813 volume:418 year:2015 pages:1-8 extent:8 https://doi.org/10.1016/j.jim.2015.01.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U SSG-OLC-PHA 44.92 Gynäkologie VZ AR 418 2015 1-8 8 045F 610 |
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recommendations for the evaluation of specimen stability for flow cytometric testing during drug development |
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Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development |
| abstract |
The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. |
| abstractGer |
The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. |
| abstract_unstemmed |
The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. |
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Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development |
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Green, Cherie L. Jones, Nicholas Stewart, Jennifer J. Fraser, Stephanie Howell, Kathy Xu, Yuanxin Hill, Carla G. Wiwi, Christopher A. White, Wendy I. O'Brien, Peter J. Litwin, Virginia |
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Green, Cherie L. Jones, Nicholas Stewart, Jennifer J. Fraser, Stephanie Howell, Kathy Xu, Yuanxin Hill, Carla G. Wiwi, Christopher A. White, Wendy I. O'Brien, Peter J. Litwin, Virginia |
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