Publications, Pharmaceutical

Using Bioequivalence and Particle Size Distribution to Develop OINDPs

The complexity of demonstrating bioequivalence in complex locally acting orally inhaled and nasal drug products is a barrier to the successful commercialization of generics.

This paper details a study to investigate the performance of a population bioequivalence (PBE) test based on particle size distribution measurements generated by morphologically directed Raman spectroscopy. Simulations of PBE trials were conducted across a range of median particle size and span values. Trial optimization strategies are presented based on the observed data and the general applicability of the approach is underlined. Appropriate trial design can help generic developers to avoid underpowered studies when using complex in vitro techniques to demonstrate bioequivalence.

Download Publication
6 Oct 2020

Learn more about Aptar Pharma Expertise
in Nasal Drug Delivery

Find Out More

This Might Also Be of Interest

25 May 2023

Exploring the Benefits and Future Possibilities of Nasal Drug Delivery and Drug Repos...

Webinars, Pharmaceutical, Market Insights, Product Solutions, Device Innovations, Brand Differentiation

Read More
11 May 2023

Why Pharma should care about circular packaging – Futurity leading the way

Publications, Pharmaceutical, Sustainability, Device Innovations, Brand Differentiation, Product Solutions

Read More
10 May 2023

Navigating the Development for Orally Inhaled and Nasal Drug Products

Publications, Pharmaceutical, Product Solutions, Device Innovations, Market Insights

Read More
2 May 2023

Using Intranasal Delivery for Drug Repositioning: A Compelling Proposition for Lifecy...

Publications, Pharmaceutical, Brand Differentiation, Market Insights, Product Solutions, Device Innovations

Read More
1 2 3 4 5 29
Back To Top