International Regulations for Bioequivalence Approval of Locally Acting
Orally Inhaled Drug Products
Abstract
Bioequivalence (BE) is established between the brand drug and the
generic drug to allow the linking of preclinical and clinical testing
conducted on the reference listed drug. Regulatory agencies around the
globe have come up with the guidance for locally acting orally inhaled
drug products (OIDPs) for bioequivalence approaches. The prime intent of
the present article is to compare approaches of different international
regulatory authorities such as Health Canada, European Medicines Agency
and the US Food and Drug Administration that have published guidance
related to locally acting OIDPs. Moreover, the Central Drugs Standard
Control Organisation, India, has published guidelines for
bioavailability and bioequivalence studies. BE recommendations from
global regulatory agencies were based on comparison for different
parameters, namely inhaler device, formulation, reference product’s
selection, in-vitro as well as in-vivo studies (pharmacokinetics,
pharmacodynamics, and clinical studies). In the case of in-vivo studies,
details about study design, dose choices, inclusion/ exclusion criteria
of the subject, study period, endpoint study, and equivalence acceptance
criteria were discussed in the present review article.