The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers. In the US, Boehringer Ingelheim markets its ipatropium MDI for the treatment of COPD under the brand name Atrovent.
The recommended tests included five in vitro tests, a PK study, and a PD study. The draft guidance notes that if the reference product includes a dose counter (which Atrovent does include), the test product should also have a dose counter and robustness studies should be performed.
View the draft guidance.
