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

18 Dec 2023

Elevating Medication Adherence and Clinical Outcomes with Connected Drug Delivery

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

Read More
13 Dec 2023

Advancing Inhaled & Nasal Drug Clinical Studies: Insights & Strategies

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

Read More
6 Nov 2023

Nasal Inhalation Testing: IPAC-RS Droplet Size Analysis

Publications, Pharmaceutical, Innovation & Insights, Market Insights, Product Solutions

Read More
13 Oct 2023

Nasal Drug Delivery: In Vitro Anatomical Models

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

Read More
1 2 3 4 5 32
Back To Top