top of page

ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation

In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.

The objective of the validation of an analytical procedure is to demonstrate that the analytical procedure is suitable for the intended purpose.

Detailed guidelines and recommendations are provided in Q2(R2) on how to derive and evaluate each analytical procedure's validation test. This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted to the ICH member regulatory authorities.



This guideline describes the science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products.

This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological).


The draft guidance is intended to decrease the risk of adverse events from interactions associated with taking more than one drug. The guidance provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product.


The purpose of this guideline is to provide recommendations for and promote international harmonization of, the use of pediatric extrapolation to support the development and authorization of pediatric medicines. This guideline recommends approaches to assessing factors that influence the determination of the similarity of disease and response to treatment between a reference and pediatric target population


Also, they release questions and answers, for E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential which is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.





Kommentare


bottom of page