Application of the EU Guidelines for Pharmacokinetic Studies of Locally Acting Orally Inhaled Drug Products
Dissanayake S.
Respiratory Drug Delivery 2010. Volume 1, 2010: 293-304.
Abstract:
In view of the limited sensitivity of traditional therapeutic effect models to compare generic and reference orally inhaled products (OIPs), the revised European regulatory guidance on the development of OIPs advocates the use of pharmacokinetic studies to determine bioequivalence. This paper summarizes issues which should be considered in the design of such studies to increase the likelihood of their acceptance by regulatory authorities.
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