Bridging the Gap: Enhancing the Clinical Realism of In Vitro OINDP Testing

In an era where the demand for generic orally inhaled and nasal drug products (OINDPs) is on the rise, accelerating time to market and adopting better practice in product development, manufacture and quality assurance are growing areas of importance for the pharmaceutical industry.

Though the core in vitro tests for OINDPs, Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD), are highly repeatable and validated methods relied upon for quality control (QC), identifying robust relationships between these OINDP characteristics and clinical efficacy is notoriously challenging. This is largely due to the complex interaction between formulation, device, and the impact of patient-to-patient variability.

Bridging this gap could help developers better understand product behaviour and optimise performance. Watch our on demand webinar, as we discuss these challenges and explore solutions that enhance the clinical realism of in vitro testing, with a focus on realistic breathing patterns and throat and nose models.

Watch the recording here


About the Presenter

Dr Clair Brooks | Applications Specialist 

As an accomplished life sciences professional, Clair has extensive experience supporting the start-up and operation of heavily regulated testing labs across both industry and academia. Offering in-depth application support to those working with orally inhaled and nasal drug products (OINDPs) and other pharmaceutical dosage forms, Clair helps analysts ensure regulatory compliant testing and advises on how best to apply Copley products and services to help maximise return on investment.

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