Event
This course provides an in-depth overview of IVIVC by exploring the relationship between the physicochemical and pharmacokinetic properties of a drug substance and a drug product. The correlation can help predict in vivo performance of a pharmaceutical dosage form based on its in vitro performance—an important basis for setting biorelevant specifications in line with the efficacy and safety of a drug product. This course will also include a short review of dissolution theory, in vitro data requirements, equipment qualification, and method validation, as described in USP–NF General Chapters <711>, <724>, and <1092>
Upon completing this course you will be able to:
- Explain USP–NF General Chapter <1088>
- Describe the importance of dissolution testing
- Identify design elements for the BA/BE study of an IVIVC
- Discuss the probability of IVIVC derived from BCS categorization
- Describe the three correlation levels as illustrated in USP–NF General Chapter <1088>
- Apply robust IVIVC and set specifications for dissolution testing
Who Should Participate:
- Chemists
- Dissolution specialists
- Lab managers
- QA/QC staff
- Analytical scientists
- Regulatory scientists
- Product development professionals