title: Bioequivalence of inhaled drugs: fundamentals, challenges and perspectives.
abstract: Interest in bioequivalence (BE) of inhaled drugs derives largely from the desire to offer generic substitutes to successful drug products. The complexity of aerosol dosage forms renders them difficult to mimic and raises questions regarding definitions of similarities and those properties that must be controlled to guarantee both the quality and the efficacy of the product. Despite a high level of enthusiasm to identify and control desirable properties there is no clear guidance, regulatory or scientific, for the variety of aerosol dosage forms, on practical measures of BE from which products can be developed. As more data on the pharmaceutical and clinical relevance of various techniques, as described in this review, become available, it is likely that a path to the demonstration of BE will become evident. In the meantime, debate on this topic will continue.
authors: Department of Dermatology, Massachussets General Hospital, Boston, MA 02114, USA. gapiou@partners.org
authors: Gabriela
authors: G
authors: Apiou-Sbirlea
authors: Steve
authors: S
authors: Newman
authors: John
authors: J
authors: Fleming
authors: Ruediger
authors: R
authors: Siekmeier
authors: Stephan
authors: S
authors: Ehrmann
authors: Gerhard
authors: G
authors: Scheuch
authors: Guenther
authors: G
authors: Hochhaus
authors: Anthony
authors: A
authors: Hickey
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols / Q000493:pharmacokinetics*; D006801:Humans; D021621:Imaging, Three-Dimensional; D008168:Lung / Q000000981:diagnostic imaging / Q000378:metabolism*; D008954:Models, Biological; D049268:Positron-Emission Tomography; D012107:Research Design; D012119:Respiration; D013810:Therapeutic Equivalency; D015899:Tomography, Emission-Computed, Single-Photon
chemical_list: D000336:Aerosols