350. QUALITY ASSURANCE FOR IN VITRO ALTERNATIVE TEST METHODS: QUALITY CONTROL ISSUES IN TEST KIT PRODUCTION.

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Rispin¹, A., Harbell², J.W., Klausner³, M., Jordan⁴, F.T., Coecke⁵, S., Gupta⁶, K., Stitzel⁷, K. ¹US Environmental Protection Agency, Office of Pesticide Programs (7506C), Washington, DC, USA; ²Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA; ³MatTek Corporation, Ashland, MA, USA; ⁴Charles River Endosafe Corporation, Wilmington, MA, USA; ⁵European Centre for the Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy; ⁶US Consumer Product Safety Commission, Bethesda, MD, USA; ⁷Consultant, West Chester, OH, USA. ATLA, 32, (1), 725-729, (2004).

Summary: 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 utilize 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 formalized oversight of the quality of these materials.

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EpiDerm Data Sheet

EpiDerm Specifications

EpiDerm Technical References

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EpiOcular Data Sheet

EpiOcular Specifications

EpiOcular Technical References

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Applications: Reproducibility - eye (ocular) tissue model, Reproducibility - skin tissue models, Validation - in vitro tissue models

Keywords: Alternative test methods, Animal test replacement, ECVAM, ET-50, EpiDerm, EpiOcular, FDA, GCCP, GLP , GMP, Good cell culture practice (GCCP), ICCVAM, In vitro, Intra-lot reproducibility, Limulus assay, MTT, MTT ET-50 assay, OECD, Pyrogen testing, Quality assurance, Reproducible , Skin constructs, Test kits, Validation

Endpoints: MTT ET-50

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