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.
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
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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.