Related Experiment Video
Updated: Jan 28, 2026

Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
Published on: April 6, 2017
A new hypothesis to investigate bioequivalence of pharmaceutical inhalation products
Maryam Khoubnasabjafari1, Elaheh Rahimpour2, Morteza Samini3
1Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Background:
This short communication reports a new hypothesis regarding bioequivalence of inhalation products which can potentially provide a reliable means to compare pharmaceutical aerosol formulations and inhalers.
Methods:
Available methods regarding the bioequivalence studies, inhaled drugs and advantages of exhaled breath condensate (EBC) samples were reviewed to develop this hypothesis.
Results:
It is postulated that two inhalation products providing the same drug concentrations in airway lining fluid (ALF) could be considered bioequivalent. The use of EBC tests which reflect ALF composition can be recommended as an alternative to current testing methods for consideration of bioequivalence.
Conclusion:
The methods based on EBC analysis can potentially be applied to bioequivalence study of inhalation products and could reflect drug concentration in ALF. However, experimental studies would be necessary to support or refute this hypothesis on the novel application of EBC to bioequivalence in the future. Graphical abstract In vitro (cascade impactor) and In vivo (EBC concentration) corrolation for inhaled drugs.
More Related Videos
15:04Modeling and Simulations of Olfactory Drug Delivery with Passive and Active Controls of Nasally Inhaled Pharmaceutical Aerosols
Published on: May 20, 2016
05:44Novel Methods for Intranasal Administration Under Inhalation Anesthesia to Evaluate Nose-to-Brain Drug Delivery
Published on: November 14, 2018
Related Concept Videos
Bioequivalence: Overview
What is a Hypothesis?
Pharmaceutical Equivalents
Inhaled Medications
Bioequivalence studies: Biowaivers
Types of Hypothesis Testing
When the null and alternative hypotheses are stated, it is observed that the null hypothesis is a neutral statement against which the alternative hypothesis is tested. The alternative hypothesis is a claim that instead has a certain direction. If the null hypothesis claims that p = 0.5, the alternative hypothesis would be an opposing statement to this and can be put either p > 0.5, p < 0.5, or p...