ICH guideline
ICH S3A Q&As: Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic…
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S3A Q&As |
|---|---|
| Title | Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This S3A Implementation Working Group (IWG) was endorsed by the ICH Steering Committee in October 2014. Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the S3A Guideline on toxicokinetics have resulted in the need for some clarification. The Questions… |
| File | S3A Q&As Step2 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S3A Q&As Step2 Presentation Files published by ICH
- None 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.