LLNA

Oded
07/11/2013 09:49

As part of Biocompatibility testing, for Skin Sensitization we perform the Local Lymph Node Assay (LLNA) according to OECD guideline for testing 429. Based on this guideline Preparation of cell suspensions for the Determination of cellular proliferation (incorporated radioactivity) is carried out in 10 mL scintillation vials. Our Beta counter is suitable for 96 well plates (and not for the recommended vials) . My Question is whether it is acceptable to make the preparation in 10 ml scintillation via and then take 250-300µl for evaluation in a 96 well Beta counter. (Even though the guideline specify 10 mL of scintillation vials)

Anon
10/11/2013 17:14

Purely from the GLP compliance standpoint, you will be OK so long as your approach is clearly supported in the study plans and SOPs, and stated in the study reports. However, sponsors and receiving authorities may have a view on this and you would be well advised to seek their opinion also.

RQA GLP Committee
03/12/2013 20:55

Response following discussion at a recent GLP Committee Meeting We would definitely consult sponsors and receiving authorities on this, as suggested above. If it is decided to go ahead we recommend a risk assessment and scientific judgement of the effect of using the sub-sample. The Deviation from the OECD Guideline would need to be specified in the study report.

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