Guidance Document on Good In Vitro Method Practices (GIVIMP)

image of 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.


Performance of the method

Key message: In vitro method developers need to ensure that in vitro methods they design will produce good quality data, i.e. fit for purpose, thanks to a stringent assessment of the performance of the method.Key content: Elements of experimental design and how to determine the performance of a method are detailed, including aspects of plate layout, data analysis, and in-house method validation, including the assessment of linearity, range, accuracy, etc.Guidance for improved practice: Details are given to increase the reliability of endpoint calculations when multiple independent experiments are run and to use tools to quantify performance characteristics.Recommendations are given to in vitro method developers on how to increase the possibility of adoption of their method for regulatory purposes.


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