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

1 Apr 2018

A track record of success for nasal drug delivery in drug repurpo...

Publications, Pharmaceutical, Innovation & Insights, Device Innovations, Brand Differentiation, Product Solutions

Read More
1 Dec 2017

Connected Health – An Effective Solution to Improve Patient Adh...

Publications, Pharmaceutical, Innovation & Insights, Device Innovations, Brand Differentiation, Product Solutions

Read More
16 Sep 2016

The Nasal Drug Delivery Journey: from Systemic to Nose-to-Brain?

Webinars, Pharmaceutical, Market Insights, Product Solutions, Innovation & Insights, Device Innovations

Read More
3 Jun 2015

Using multi-dose nasal spray pumps for intranasal drug delivery

Publications, Pharmaceutical, Innovation & Insights, Device Innovations, Product Solutions

Read More
1 22 23 24
Back To Top