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    Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2)

    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 addi...