MINUTES OF THE TELECONFERENCE OF THE PQRI PSD PROFILE COMPARISONS WORKING GROUP ON 9 JANUARY 2006
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1 APSD Profile Comparisons Working Group MINUTES OF THE TELECONFERENCE OF THE PQRI PSD PROFILE COMPARISONS WORKING GROUP ON 9 JANUARY I. PARTICIPANTS David Christopher (Schering-Plough), Chair Wally Adams (FDA) Craig Bertha (FDA) Bill Doub (FDA) Walter Hauck (Thomas Jeff. U.) Quan Li (FDA) Lana Lyapustina (IPAC-RS) Jolyon Mitchell (Trudell Medical) Ziqing Pan (Schering-Plough) Bruce Wyka (Schering-Plough) II. OPENING Mr. Christopher opened the teleconference and reviewed the agenda. Dr. Lyapustina reminded the participants of the competition guidelines and cautioned against any discussion of competitively sensitive subjects. The objective of the teleconference was to discuss the results of the recent assessment of modified scenarios III. DISCUSSION Mr. Christopher reminded the participants that on the previous call, the Working Group agreed to change variability in some scenarios to approximate changes that might be observed, for example, upon automation of the test or upon going to a different laboratory. The results of these assessment (presented in Exhibits A and B below) demonstrate that the combined test s decision does change if the variability of both profiles (but not mean recoveries) change. Dr. Bertha commented that the sensitivity to the changed variability, at least in these cases, came primarily from the ISM portion of the combined test. The participants agreed that this point should be noted in the report to the FDA. One possible consequence of this feature of the test is that by choosing a method / laboratory with desired variability, different results of the in-vitro BE assessment might be obtained. Dr. Mitchell and Dr. Doub confirmed that in their experience manual CI methods are more variable than automated CI methods. The participants also noted that while larger companies may be moving in the direction of fully automated methods, many smaller companies do not, due to large investments required. Dr. Doub asked whether there is a required limit on variability for the CI results to be considered, and Dr. Adams explained that the guidance on bioanalytical method
2 APSD Profile Comparisons Working Group Page 2 of IV. validation, which was developed about a half decade ago, does not address this in vitro issue. The participants further discussed the fact that a significant change in variability due to automation suggests that the method variability is a major contributing factor in the overall variability of CI measurements, and in fact is more significant than the product variability. (A post-teleconference message indicated that while this is true for conventional products, this may not apply to low-dose products, in which noise from the product is the determining factor). In conclusion, Mr. Christopher indicated that the revised paper would be provided for review and comment in the near future. AGREEMENTS Dr. Hauck will work with Mr. Christopher and Dr. Pan to consider different scaling for the PBE method, which may result in re-assessment of the scenarios with the revised PBE method. V. NEXT TELECONFERENCE/MEETING. The next teleconference will be scheduled by for January 26, Finalized on 6 February 2006
3 APSD Profile Comparisons Working Group EXHIBIT A. MODIFIED SCENARIOS 1 AND 12 A 49
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11 APSD Profile Comparisons Working Group Page 11 of EXHIBIT B. MODIFIED SCENARIOS ASSESSMENT ID Scenario E (beta ag) I (beta ag) Undecided for beta agonist Chi- Square ISM Chisq + ISM (proportion) (proportion) (proportion) "E" "E" "E/E" 1 1a b c d a(LV) b(LV) c(LV) d(LV) a a a a a0(HV) a1(HV) a2(HV) a3(HV)
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