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

September 28, 2022

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.

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BIO Comments_Q2R2 Q14_FDA 2022_D_1503
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BIO provides comments to the Office of Policy and International Affairs, U. S. Patent and Trademark Office (Docket ID: PTO-C-2023-0019)
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)