Guidance Document on Good In Vitro Method Practices (GIVIMP)
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.
Test and reference/control items
Key message: The preparation and characterisation of test, reference and control items and their interaction with the in vitro environment should be well understood so as to ensure the acquisition of reliable and relevant results. Key content: Described are test item (characterisation, solubility and handling), test system and test item interaction and biokinetics during development to ensure test item compatibility and correct and reliable exposure.Guidance for improved practice: More detailed information on solubility determination methods; the limitations of test items for which the method is suitable will allow the reader to choose the most suitable approach for his/her particular needs.Recommendations Identify suitable reference and control items to avoid interference of the test, reference and/or control items with the in vitro method