Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced knowledge on analytical methods should be conveyed in regulatory submissions and whether smaller companies would have the necessary resources to invest in the enhanced approach in Q14.
Other groups had questions related to the use of multivariate modeling in analytical method development. In addition, there were calls for the two guidelines to be better integrated.
The comments were submitted in response to European Medicines Agency (EMA)’s call for feedback on the two guidance documents. (RELATED: ICH releases draft guidelines on analytical method development, Regulatory Focus 31 March 2022)
The guidelines should make it easier for manufacturers to switch analytical methods for testing medicines postapproval and are aimed to promote more robust analytical processes…
