As the workshop evolved over the planning states, the committee decided to expand its scope to include new methods of looking at existing tests, including the abbreviated impactor method (AIM) and the efficient data analysis (EDA) concept for cascade impaction. As a result, the workshop will present separate sessions on AIM and EDA, plus a session on delivered dose uniformity (DDU) for which the objective is: “A Review of Scientifically Based Alternatives for Aerosol Content Uniformity: Bringing <601> into the 21st Century or Leaving it in the 20th.”
In those sessions, attendees will have more of an opportunity to influence the committee, says Hickey; as changes in the science around test methods occur, “Those things tend to be brought to our attention, and then we have to ponder them a little bit before we make recommendations for changes or their inclusion in the general chapters.”
Although he warns that “there should be no inference that because we are discussing it, it necessarily will result in change,” Hickey says, “I think we’ll be picking up on the general tone of those two sessions, whether people feel that either of the approaches that are being mentioned have moved to a point where they should be included in the pharmacopoeia. It may well be that the debate is still so strong scientifically that we would say, ‘well that should probably be tabled for a few years’ or if everybody is agreeing, then maybe we will say ‘that should be put on the agenda.’”
The final session of the workshop will review the new information Chapter <1601>, which covers nebulizer testing, and a proposed chapter on spacers. “These are both topics which have historically not been addressed by USP but which we know people need some guidance on,” Hickey explains.
Early bird registration for the workshop ends on November 12th. The complete program is available here.
