Publications, Pharmaceutical

Exploring a Faster, More Cost-Effective Alternative to Generic Bioequivalence

Across the globe rising rates of respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD) increase the need for cost-effective Orally Inhaled and Nasal Drug Products (OINDPs). This article explores the challenges faced when bringing generic OINDPs to market and the complex and changing regulatory landscape for respiratory drug delivery. Aptar Pharma Services is an integrated offering that draws together expertise and solutions from across the Aptar family of companies, such as Gateway Analytical and Nanopharm, to help pharma partners to navigate these challenges. The company’s capability to accelerate and de-risk generic OINDP development is discussed focusing on Nanopharm’s SmartTrack™ process which uses multiple methodologies to generate the information needed for streamlined regulatory approval of an inhaled generic, potentially eliminating the need for clinical endpoint bioequivalence studies.

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Author(s): Jag Shur
1 Nov 2019

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