In Vitro Bioequivalence for Pulmonary and Nasal Delivery - Where are we now?

ONdrugDelivery Issue No 102, November 11th, 2019 PULMONARY & NASAL DELIVERY

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With a focus on bioequivalence testing in the development of generic inhalables, Mark Parry, Technical Director, Intertek Melbourn, highlights some of the shortcomings of aerodynamic particle size distribution and delivered dose testing, and introduces newer testing techniques that Intertek offers to allow its clients to de-risk clinical studies or even to support robustly in vitro data submissions as to avoid clinical work.

Download from this link: https://www.intertek.com/knowledge-education/invitro-bioequivalence-generic-oindp-article/

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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