Bioequivalence of Orally Inhaled Drug Products : Focus on Current Regulatory Perspectives.
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Date
2015-04
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Abstract
Asthma/chronic obstructive pulmonary disease (COPD)
medication market is a fast growing market, especially in
the emerging markets where drugs have not been launched
due to high costs. Use of generic medicines has been
increasing in recent years, primarily as a cost saving
measure in healthcare provision. Orally inhaled products
(OIPs) should continue to remain an attractive clinical
proposition. At the same time, establishing bioequivalence
of an inhaled therapeutic can be a challenging proposition.
The purpose of establishing bioequivalence is to demonstrate
equivalence between the generic medicine and the originator
medicine in order to allow bridging of the pre-clinical and
clinical testing performed on the originator drug.
Methodologies to determine bioequivalence are well
established for oral, systemically acting formulations.
However, for inhaled drugs, there is currently no universally
adopted methodology, and regulatory guidance in this area
has been subject to debate. There is no one-size-fits-all
programme. This review article mainly focused on current
regulatory perspectives on bioequivalence of topically acting,
orally inhaled drug products.
Description
Keywords
bioequivalence, guidance, orally inhaled drug products, US, EU
Citation
Sapakal Vinayak, Govindasamy Jeyabalan. Bioequivalence of Orally Inhaled Drug Products : Focus on Current Regulatory Perspectives. Indian Medical Gazette. 2015 Apr; 149 (4): 151-161.