Bioequivalence of Orally Inhaled Drug Products : Focus on Current Regulatory Perspectives.

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dc.contributor.authorSapakal, Vinayak
dc.contributor.authorGovindasamy, Jeyabalan
dc.date.accessioned2015-07-08T06:37:48Z
dc.date.available2015-07-08T06:37:48Z
dc.date.issued2015-04
dc.description.abstractAsthma/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.en_US
dc.identifier.citationSapakal Vinayak, Govindasamy Jeyabalan. Bioequivalence of Orally Inhaled Drug Products : Focus on Current Regulatory Perspectives. Indian Medical Gazette. 2015 Apr; 149 (4): 151-161.en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/159283
dc.language.isoenen_US
dc.source.urihttps://medind.nic.in/ice/t15/i4/icet15i4p151.pdfen_US
dc.subjectbioequivalenceen_US
dc.subjectguidanceen_US
dc.subjectorally inhaled drug productsen_US
dc.subjectUSen_US
dc.subjectEUen_US
dc.subject.meshAdministration, Inhalation
dc.subject.meshAdministration, Oral
dc.subject.meshAerosols --pharmacokinetics
dc.subject.meshHumans
dc.subject.meshPharmacokinetics --methods
dc.subject.meshPharmacokinetics --standards
dc.subject.meshTherapeutic Equivalency
dc.titleBioequivalence of Orally Inhaled Drug Products : Focus on Current Regulatory Perspectives.en_US
dc.typeArticleen_US
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