MERIT White Paper:

Methacholine Bronchoprovocation in Bioequivalence Studies

Many generic drug companies are developing programs for albuterol sulfate. CROs are seeing 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.


Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget. Your success is our priority.