ABSTRACT
Given here are recommendations for planning product quality studies to measure bioavailability and/or establish bioequivalence in support of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for locally acting drugs in nasal aerosols (metered-dose inhalers [MDIs]) and nasal sprays (metered-dose spray pumps). Product quality includes chemistry, manufacturing, and controls (CMCs), microbiology, certain bioavailability information, and bioequivalence information (i.e., information that pertains to the identity, strength, quality, purity, and potency of a drug product). Product quality bioavailability and bioequivalence are reective of potency, in that release of the drug substance from the drug product should be assessed and controlled to achieve a reproducibly potent product. The bioavailability studies can address many questions, but the studies that focus on product performance (i.e., release of drug substance from drug product) are important to consider. A bioequivalence study is normally used to compare a test product (T) to a precursor product (R)—the to-be-marketed product is compared to a pivotal clinical trial material; a generic product is compared to a reference listed drug.
