Synopsis of recent research by authors named "Olivier Dirat"
- Research by Olivier Dirat focuses on the assessment and management of carcinogenic impurities, particularly N-nitrosamines, in pharmaceutical products, emphasizing the need for refined categorization approaches and acceptable intake limits based on scientific evidence.
- Dirat has contributed to the understanding of Design Space (DSp) concepts within quality-by-design frameworks for drug development, highlighting the regulatory variances and industry perspectives regarding DSp applications in pharmaceutical filings.
- His work also explores innovative methodologies, such as kinetic modeling to assess nitrosamine carcinogenicity and strategies to establish acceptable intake levels for drug product impurities, addressing significant challenges in pharmaceutical quality management.
