ICH M9: Harmonization of Biopharmaceutics Classification System (BCS)-Based Biowaivers
Joint AAPS / IQ Consortium webinar on ICH M9: Harmonization of Biopharmaceutics Classification System (BCS)-Based Biowaivers
About this webinar
In 1995, Dr. Gordon Amidon et al. published a biopharmaceutics classification system (BCS) that utilized a drug’s solubility and permeability to judge the likely impact of in vitro drug product dissolution properties on in vivo absorption and bioavailability. In 2000, the FDA issued a guidance for the industry on what was needed to obtain a waiver of a human bioequivalence study (biowaiver) for immediate-release solid oral dosage forms based on the BCS. Since then, many global regulatory agencies have adopted guidances on the use of BCS-based biowaivers. Unfortunately, there has been a lack of international harmonization and these differences have impacted country-by-country product biowaiver designation even when utilizing the same supportive data. In October 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) began efforts to provide recommendations to harmonize guidances for BCS-based biowaivers, and the updated guidance was recently issued, effective on July 30, 2020.
Join four experts who are part of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) working group intricately involved in the ICH M9 negotiation and harmonization efforts. The panelists will highlight aspects from their working group discussions, including consideration of the dose used to classify solubility, criteria for establishing high permeability, dissolution conditions and permitted excipient changes. They will talk about observed gaps, challenges, and aspects of the future direction of the field that are not addressed in the current guidance as well as the general process in developing an ICH guidance.
The 3 September webinar included panelist discussion at the end of the presentations, as well as audience Q&A.
Click here for contributor biographies.
AAPS presented this session in collaboration with the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium).
Click here to watch the ICH M9 Harmonization of Biopharmaceutics Classification System Based Biowavers webinar on demand!