Bioequivalence and Bioavailability Forum

Hi Tarak,

❝ Can anyone share regulatory guidance on spreadsheet validation?

I’m not aware of any one specific for spreadsheets. For computerised systems the EMA’s GCP Inspectors Working Group recommended the guidelines issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Navigate to Publications and have fun with PI 011-3.

❝ Do we need to validate dose calculation sheet for clinical study?

Sure! Dose is to most important independent parameter in PK. Otherwise you may end up with something like in this case. As an appetizer see Esch et al.* No, it is neither fun nor easy to do.

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• Esch PM, Moor C, Schmid B, Albertini S, Hassler S, Donzé G, Saxer HP. Good Laboratory Practice (GLP) – Guidelines for the Development and Validation of Spreadsheets. Qual Assur J. 2010: 13(3–4); 41–56. doi:10.1002/qaj.466.