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June 2, 2011
Panel Members: Jake Thiessen (Chair), Robert Herman, Elaine Jolly, William Racz, Heather Shapiro, Daniel Sitar, Scott Walker
Health Canada Representatives: Supriya Sharma, Therapeutic Products Directorate Team
The Director General opened the meeting by welcoming the members and introducing Health Canada representatives through a formal roundtable. Dr. Sharma indicated that the members will be consulted on issues concerning appropriate bioequivalence study requirements for pharmaceutical drug products intended for gender-specific administration. Specifically, the questions posed to the panel members will revolve around the requirements for inclusion of males only, females only, or males and females in bioequivalence trials for products that are intended for use in pregnant women. Dr. Sharma thanked all panel members for their time and effort in participating in this meeting and wished everyone good and productive deliberations.
The Chair welcomed the panel members.
The Chair gave a brief overview of Health Canada's processes and policies revolving around bioequivalence requirements. He informed the panel members that Health Canada has asked for the panel's expert advice regarding any specialized requirements for a second entry or subsequent entry gender-specific drug product to acquire market authorization in Canada. Specifically, the panel is to answer the three questions posed to them contained in Tab 4 of the binder sent to them.
The Chair asked the panel members whether there have been any changes in their affiliations and interests since they were last declared to Health Canada. Upon confirmation of the declarations, it was unanimously agreed that all members could participate fully in the meeting and the Chair encouraged free and open discussion.
The Chair asked for any comments regarding the Terms of Reference. All panel members accepted the Terms of Reference as is.
The Chair asked for comments on the Mei-Ling Chen publication which analysed studies submitted to the FDA which contained both males and females. The paper contained gender analysis of intra-subject variation, relative mean area under the curve (AUC) and maximum observed concentration (Cmax.)
Members noted that the studies presented in this paper were small and not designed to address the question of whether or not a gender by formulation interaction exists. The panel suggested that while there might be differences due to gender, in a crossover study when formulations are compared in the same subject, these differences are negated or minimized. The panel members agreed that this paper, on its own, presents no compelling evidence to warrant a gender specific study in bioequivalence testing.
The Chair requested comments from the panel regarding the Gideon Koren Editorial. The panel members noted that this editorial does not apply to issues in bioequivalence but rather focuses on other issues, some of which are used in the determination of bioequivalence. Members supported the article's premise that pharmacokinetics of drugs are different in pregnant women than in men, however, this difference is not applicable to the assessment of comparative bioavailability using a crossover design.
*Scientific and proprietary information redacted as per Access to Information (ATI) Act s. 20(1)
Health Canada posed the following questions to the panel for their considered opinion:
The Chair thanked panel members for their participation and effort and also to all Health Canada personnel.
Dr. Sharma concluded that the discussion had been very productive and thanked the panel members for their valuable time.
The meeting was adjourned.
*Scientific and proprietary information redacted as per ATI Act s. 20(1)