25 October 2018

The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in the ICH Q3C(R6) Guideline, and the Q3C Support Documents 1, 2 and 3, which contain the summaries of the toxicity data from which the PDEs were derived for the original ICH Q3C Guideline, are now available on the ICH website.

Furthermore, as a result of the publication of the error corrected Guideline ICH Q3C(R7), the code of the Maintenance Expert Working group (EWG) working on the development of the PDE levels for 2-methyltetrahydrofuran, cyclopentylmethylether and tert-butanol, has been changed to Q3C(R8) Maintenance EWG.

Further information can be found on the Q3C(R7) and Q3C(R8) pages, including the Q3C(R7) Guideline and Q3C Support Documents for download.