TESTS AND METHODS

The ITFG/IPAC-RS Collaboration submitted its paper, Recommendations for Tests and Methods, and accompanying Appendices to the Agency on 18 May 2001. The document offers recommendations regarding testing and methodology for MDIs. The Collaboration proposes in general that (i) certain tests for MDIs may be effective in assuring product quality and should be evaluated during drug development studies, and (ii) proper assessment of development studies should determine the need to use certain tests for quality control of the final product. The Collaboration also proposes that alternate methods (other than Andersen cascade impaction) should be allowed for particle size distribution determination.