The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for ...
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...
In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 ...
In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15 November 2018 also was informed of progress made on a ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results