MERIT White Paper:

Methacholine Bronchoprovocation in Bioequivalence Studies

Partly in response to potential inhaler shortages arising due to treatment of COVID-19, the U.S. Food and Drug Administration (FDA) approved the first generic version of Proventil HFA (albuterol sulfate) in the U.S. in April 2020.

 

This approval could provide an incentive to generic drug companies to develop or prioritize a program for albuterol sulfate. CROs may see new requests from clients regarding albuterol sulfate bioequivalence (BE) studies. When evaluating such a drug program, it is vital to bear in mind the complexities of this type of BE study.

 

Dr. Gordon Raphael, a board-certified allergist-immunologist with over 40 years of experience in clinical trial research, has first-hand knowledge of the intricacy of the methacholine bronchoprovocation challenge (MBPC) model.

 

“I have conducted many complex respiratory trials over the years, but there’s no doubt that MBPCs are some of the most difficult. Studies undertaken with this model require high-quality spirometry acquisition software and equipment. Even more crucial is having a CRO team with deep understanding of the challenge process.” – Dr. Gordon Raphael

In this white paper you will learn four potential issues presented in MBPCs and how you can solve for these with MERIT.


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