Zdrowie i gospodarka · 20/02/2002

Draft Guidance for Industry on Exercise-Induced Bronchospasm (EIB)-Development of Drugs to Prevent EIB; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Exercise- Induced Bronchospasm (EIB)--Development of Drugs to Prevent EIB." The draft guidance is intended to assist sponsors in developing clinical trials for drugs that prevent EIB. The draft guidance addresses the types of trials that should be performed. It also discusses such issues as exercise testing, efficacy end points, and statistical analyses.