European Perspective on Orally Inhaled Products: In Vitro Requirements for a Biowaiver

Authored by: Sunita Chaudhary , Dhaval Patel , Dasharath M. Patel , Jayvadan K. Patel

Handbook of Lung Targeted Drug Delivery Systems

Print publication date:  October  2021
Online publication date:  October  2021

Print ISBN: 9780367490676
eBook ISBN: 9781003046547
Adobe ISBN:


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In recent years there have been many changes in the regulation of orally inhaled drug products in the European Union and its respective countries. The International Conference of Harmonisation has harmonized the regulatory requirements for the approval of generic drugs which act systemically. In the European Union, there is a systematic methodology to track the progress and assessment of generic orally inhaled drug products. In a solution for nebulization, equivalence can be shown by in vitro data only. If it cannot be established that way, then a conventional pharmacokinetic approach is used for an assessment of lung deposition and systemic exposure. If equivalence is not established by use of only pharmacokinetic data only, the applicant can proceed using the alternate method of establishment of equivalence by a pharmacodynamics study, but relative potency and assay sensitivity must be demonstrated and estimated, respectively. This chapter highlights thein vitro requirement for orally inhaled drug products in the European Union and its possible biowaiver with different strengths.

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