Value to Set in INTERVAL_DOSAGE_UNIT_E2B and INTERVAL_DOSAGE_DEF_E2B Columns to Meet ICH Regulation (Doc ID 2795900.1)

Last updated on JULY 13, 2023

Applies to:

Goal

Database source for G.k.4.r.2 is LM_DOSE_FREQUENCY.INTERVAL_DOSAGE_UNIT_E2B and for G.k.4.r.3 is LM_DOSE_FREQUENCY.INTERVAL_DOSAGE_DEF_E2B.
When frequency selected in the case for example "qid" (freq_id = 7) where default value INTERVAL_DO SAGE_UNIT_E2B and INTERVAL_DOSAGE_DEF_E2B in the LM_DOSE_FREQUENCY are null,
it is understood why G.k.4.r.2 & G.k.4.r.3 is not populated in the report output.

However in order to comply with ICH regulations, and ensure G.k.4.r.2 (DRUGINTERVALDOSAGEUNITNUMB) is 0.25 in SUSAR case,
what id the suitable value need to be set in INTERVAL_DOSAGE_UNIT_E2B and INTERVAL_DOSAGE_DEF_E2B columns to meet this?

The regulation is explain in https://www.ich.org/page/efficacy-guidelines

Solution

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.