ICH guideline
ICH M12: Drug Interaction Studies
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M12 |
|---|---|
| Title | Drug Interaction Studies |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2018. The ICH M12 Guideline reached Step 4 of the ICH process on 21 May 2024. The M12 Guideline:Is limited to pharmacokinetic interactions, with a focus on metabolic enzyme- and transporter-mediated interactions;Provides recommendations on how to investigate… |
| File | M12 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M12 Step 4 Presentation Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.