Bioequivalence and Bioavailability Forum

Dear Anil!

❝ Can ruggedness expriment results include in intra day or inter day P&A?

USP defines ruggedness as "the degree of reproducibility of test results obtained by the analysis of the same samples under a variety of normal test conditions such as:

• Different laboratories
  
• Different analysts
  
• Different instruments
  
• Different reagent lots
  
• Different analysis days
  
• Different elapsed assay times
  
• Different assay temperatures..."

Different analysis days are already part of the standard method validation procedures.
For HPLC I would consider the most important factors different instruments, column batches (and/or vendors), slight changes in the composition of the mobile phase and/or the flow rate, and the column temperature. Although FDA's http://www.fda.gov/cder/guidance/4252fnl.pdf guideline (2001) calls for partial validation of "bioanalytical method transfers between [...] analysts" I have never seen a report entitled "Validation of bioanalytical method A for the determination of B in matrix C to be performed by analyst X".
Generally precision of accuracy of QCs are evaluated in ruggedness experiments; for a statistical approach see this article.

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Edit: Link corrected for FDA’s new site. [Helmut]