Webinar: An In-depth Review of In-vitro Testing for Bioequivalence of Nasal Drug Products

In-vitro testing approaches are invaluable to the support the development of this product class allowing a deep understanding of critical quality attributes (CQAs).

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In this webinar, Mark Parry, Technical Director, presented an in-depth review of the in-vitro testing required for nasal drug products including USP / EP testing requirements, typical analytical approaches, set-up, testing considerations and typical stability programmes with a particular focus on spray characterisation & particle sizing (DSD, spray pattern, plume geometry, morphologically directed Raman spectroscopy).

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Intertek Melbourn

Intertek Melbourn has specialist skills and experience in analytical testing and formulation for both small molecule and biologic orally inhaled and nasal drug products (OINDP), alongside all other pharmaceutical dosage forms. With 30 years of experience in supporting our clients’ inhaled and nasal product developments, we deliver world-class support for method development / validation, analytical testing, stability programs, CMC studies, formulation development and clinical manufacturing from our facility located in Melbourn, near Cambridge, UK. Our team of scientists have a reputation for providing outstanding and responsive customer service and we have recently announced a significant expansion to double our laboratory footprint and further increase our capacity and flexibility. Through our expertise in analytical and formulation support for the pharmaceutical, biotechnology and drug delivery industries, we help our clients to meet milestones for their challenging pharmaceutical development programmes. The laboratory is inspected and approved by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GMP compliance. The Laboratory has also been inspected by the US Food and Drug Administration (FDA) against GMP as part of clients’ pre-approval inspections. • Method Development / Validation • Analytical Testing • Formulation Development • Device Screening • Quality by Design (QbD) Studies • ICH and Accelerated Stability Studies • Clinical Trials Materials Manufacturing • Product Characterisation Studies • In-Vitro Bioequivalence Studies for Generic Products
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