ICH guideline
ICH Q5B: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q5B |
|---|---|
| Title | Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 1995. This document is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins. |
| File | Q5B Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- Q5B Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.