ALEXANDRIA, Va. -- The American Association of Pharmaceutical Scientists (AAPS) will host the AAPS International Workshop on Individual Bioequivalence: Realities and Implementation on August 30 - Sept. 1, 1999, at the Montreal Marriott Chateau Champlain in Montreal, Quebec, Canada. Co-sponsors of the workshop are the Board of Pharmaceutical Sciences/Federation Pharmaceutique International, the Canadian Society of Pharmaceutical Sciences, the Food and Drug Administration (FDA), and the Therapeutic Products Programme, Health Canada.
The goals and objectives of the workshop are to:
- Review available criteria (average, population and individual) to all comparisons of bioequivalence metrics;
- Discuss the pros and cons of each criterion;
- Review the motivation for current and proposed criteria, focusing on evidence for/against a Subject by Formulation interaction;
- Discuss statistical issues associated with the current (average) and proposed criteria;
- Review proposed FDA strategy for moving towards criteria other than average bioequivalence, while focusing on new guidances available in draft for public comment;
- Explore the various points in drug development and approval: Investigational New Drug Application (INDA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Post-Approval Changes (PAC) when the current and proposed criteria would be used; and
- Consider other applications, such as human pharmacology and pharmaceutical equivalence.
For more information on this workshop, including a complete preliminary program, registration fees, and accommodations, visit AAPS Online at www.aaps.org/edumeet/canada/index.html.
AAPS is a professional, scientific society of more than 9,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. For more information about AAPS, visit AAPS Online at http://www.aaps.org.