Abstract
The European Centre for the Validation of Alternative Methods (ECVAM) proposes to make the validation process more flexible, while maintaining its high standards. The various aspects of validation are broken down into independent modules, and the information necessary to complete each module is defined. The data required to assess test validity in an independent peer review, not the process, are thus emphasised. Once the information to satisfy all the modules is complete, the test can enter the peer-review process. In this way, the between-laboratory variability and predictive capacity of a test can be assessed independently. Thinking in terms of validity principles will broaden the applicability of the validation process to a variety of tests and procedures, including the generation of new tests, new technologies (for example, genomics, proteomics), computer-based models (for example, quantitative structure-activity relationship models), and expert systems. This proposal also aims to take into account existing information, defining this as retrospective validation, in contrast to a prospective validation study, which has been the predominant approach to date. This will permit the assessment of test validity by completing the missing information via the relevant validation procedure: prospective validation, retrospective validation, catch-up validation, or a combination of these procedures.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 467-472 |
| Number of pages | 6 |
| Journal | ATLA Alternatives to Laboratory Animals |
| Volume | 32 |
| Issue number | 5 |
| State | Published - Nov 2004 |
| Externally published | Yes |
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Keywords
- In silico
- In vitro
- In vivo
- Modular approach
- QSARs
- Test validity
- Validation
ASJC Scopus subject areas
- Biochemistry, Genetics and Molecular Biology(all)
- veterinary(all)
Cite this
A modular approach to the ECVAM principles on test validity. / Hartung, Thomas; Bremer, Susanne; Casati, Silvia; Coecke, Sandra; Corvi, Raffaella; Fortaner, Salvador; Gribaldo, Laura; Halder, Marlies; Hoffmann, Sebastian; Roi, Annett Janusch; Prieto, Pilar; Sabbioni, Enrico; Scott, Laurie; Worth, Andrew; Zuang, Valérie.
In: ATLA Alternatives to Laboratory Animals, Vol. 32, No. 5, 11.2004, p. 467-472.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A modular approach to the ECVAM principles on test validity
AU - Hartung, Thomas
AU - Bremer, Susanne
AU - Casati, Silvia
AU - Coecke, Sandra
AU - Corvi, Raffaella
AU - Fortaner, Salvador
AU - Gribaldo, Laura
AU - Halder, Marlies
AU - Hoffmann, Sebastian
AU - Roi, Annett Janusch
AU - Prieto, Pilar
AU - Sabbioni, Enrico
AU - Scott, Laurie
AU - Worth, Andrew
AU - Zuang, Valérie
PY - 2004/11
Y1 - 2004/11
N2 - The European Centre for the Validation of Alternative Methods (ECVAM) proposes to make the validation process more flexible, while maintaining its high standards. The various aspects of validation are broken down into independent modules, and the information necessary to complete each module is defined. The data required to assess test validity in an independent peer review, not the process, are thus emphasised. Once the information to satisfy all the modules is complete, the test can enter the peer-review process. In this way, the between-laboratory variability and predictive capacity of a test can be assessed independently. Thinking in terms of validity principles will broaden the applicability of the validation process to a variety of tests and procedures, including the generation of new tests, new technologies (for example, genomics, proteomics), computer-based models (for example, quantitative structure-activity relationship models), and expert systems. This proposal also aims to take into account existing information, defining this as retrospective validation, in contrast to a prospective validation study, which has been the predominant approach to date. This will permit the assessment of test validity by completing the missing information via the relevant validation procedure: prospective validation, retrospective validation, catch-up validation, or a combination of these procedures.
AB - The European Centre for the Validation of Alternative Methods (ECVAM) proposes to make the validation process more flexible, while maintaining its high standards. The various aspects of validation are broken down into independent modules, and the information necessary to complete each module is defined. The data required to assess test validity in an independent peer review, not the process, are thus emphasised. Once the information to satisfy all the modules is complete, the test can enter the peer-review process. In this way, the between-laboratory variability and predictive capacity of a test can be assessed independently. Thinking in terms of validity principles will broaden the applicability of the validation process to a variety of tests and procedures, including the generation of new tests, new technologies (for example, genomics, proteomics), computer-based models (for example, quantitative structure-activity relationship models), and expert systems. This proposal also aims to take into account existing information, defining this as retrospective validation, in contrast to a prospective validation study, which has been the predominant approach to date. This will permit the assessment of test validity by completing the missing information via the relevant validation procedure: prospective validation, retrospective validation, catch-up validation, or a combination of these procedures.
KW - In silico
KW - In vitro
KW - In vivo
KW - Modular approach
KW - QSARs
KW - Test validity
KW - Validation
UR - http://www.scopus.com/inward/record.url?scp=19944430250&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=19944430250&partnerID=8YFLogxK
M3 - Article
C2 - 15656771
AN - SCOPUS:19944430250
VL - 32
SP - 467
EP - 472
JO - ATLA Alternatives to Laboratory Animals
JF - ATLA Alternatives to Laboratory Animals
SN - 0261-1929
IS - 5
ER -