Inhalation Asia 2019 Conference
Request our Inhalation Asia Conference presentation covering analytical strategies to accelerate generic OINDP development. Meet our team 13-15 November 2019 in Hong Kong.
We are pleased to be a Gold Sponsor of the Inhalation Asia 2019 conference, 13-15 November 2019, Hong Kong. Our experts will be at available during the exhibition to provide updates on our expansion news and our latest capabilities for OINDP development.
Conference Presentation - Thursday 14th Nov, Session 3 – Developing Inhalers
Analytical strategies to accelerate and simplify generic OINDP development
Mark Parry, Technical Director, Intertek Melbourn
In-vitro bioequivalence for the development of generic inhaled pharmaceutical products continues to provide challenges to the industry in developing and performing suitable analytical strategies to both satisfy the continuously evolving requirements of the regulators, and ensure a robust development process that ensure the developed generic product is successful. In this conference presentation, Mark Parry, will discuss the key regulatory aspects and analytical strategies to underpin the development of stronger in-vivo data packages supporting both greater clinical success and the possibility of successful in-vitro only generic approvals.
REQUEST A COPY OF THE PRESENTATION
We would be delighted to send you a copy of the presentation after the conference.
Intertek OINDP Development Expertise
Our experts provide integrated OINDP development and testing services for both small molecules and biologics through its centres of excellence across Europe. We provide critical performance and quality testing such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI) and spray pattern/plume geometry. Intertek’s integrated formulation and analytical teams carry out early stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing and device selection support. For biologic OINDP development, comprehensive protein characterisation services supported by forced degradation and stability monitoring for the protein’s structure and bioactivity throughout formulation and storage can also be provided. Interaction with the device and closure systems are evaluated through comprehensive extractable and leachable testing and toxicological assessments.
WEBINAR RECORDING:A Review of In-vitro Testing for Bioequivalence of Nasal Drug Products
WEBINAR RECORDING: Advanced analytical techniques for testing OINDPs
ARTICLE DOWNLOAD: Developing Inhaled and Nasal Biologics
BROCHURE: Intertek Inhaled Product Development Brochure
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