BIO Comments on ICH Guidelines: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development

On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of specific line edits, BIO suggested broadly that the ICH Q2(R2) document add further clarity regarding the use of linear and non-linear models, context on use of confidence intervals; and additional examples of modeling techniques and considerations for conducting multivariate analysis. On the Q14 Guideline, BIO encouraged additional language and examples to ensure the Guideline’s applicability for large molecules.