Course Description:
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>.
Date: July 17th, 18th, 19th & 20th, 2023
Couse Duration (hh:mm:ss): 18:00:00
Instructor:
Margareth Marques Senior Principal Scientist, US Pharmacopeia