Munit applies Design of Experiments (DoE) methodology to identify the most effective and stable micronization parameters for your APIs. We help clients develop robust processes that reduce variability and speed up development.
Why Use DoE in Micronization?
DoE allows you to:
- Discover interactions between process variables
- Identify optimal operating windows
- Establish CPPs and CQAs
- Streamline scale-up and validation
It’s a key tool in QbD-based development.
Our DoE Services
We offer:
- Experimental design planning
- Sample production at lab and pilot scale
- Data collection and statistical modeling
- Confirmatory runs and process validation
All results are presented in GMP-ready technical reports.
Integration into Regulatory Frameworks
Our DoE approach aligns with ICH Q8, supports regulatory filings, and provides strong justification for selected parameters in NDA or ANDA dossiers.
Make data-driven decisions for your API process.
Optimize your project with Munit’s DoE expertise.