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.
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
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.