Attending RDD 2024? Meet our team in Tucson, Arizona, (May 5-9), during the Respiratory Drug Delivery conference to discuss all aspects of pulmonary and nasal drug delivery development challenges

During RDD 2024, connect with Intertek. The Respiratory Drug Delivery 2024 Conference will take place May 5-9, 2024, Tucson, Arizona. Get in touch with our team to discuss your OINDP development challenges during the event.

RDD 2024 Workshop on Generic Nasal Suspensions
Exploring In Vitro-Only Bioequivalence Pathways for Generic Nasal Suspensions

Join Chris Vernall, Commercial Director, and Ben Stafford, Senior Analyst, as they explore IVBE test packages for generic nasal suspensions. Gain practical tips for overcoming challenges presented by complex techniques including Morphologically Directed Raman Spectroscopy (MDRS) and dissolution.

Date: Tuesday 7th May 

In 2023, the US FDA introduced new draft guidance for nasal suspension product bioequivalence (BE) requirements, providing a fully "in vitro-only" approval pathway. This workshop will explore robust testing package design for such studies. We will discuss traditional in vitro spray characterization tests for generic product submissions (SAC, DPS, SP, DISP, DSD, PG, Priming/Re-priming) and then address advanced techniques such as morphologically directed Raman spectroscopy (MDRS) and dissolution studies, emphasizing their relevance to establishing bioequivalence. Of particular interest may be the challenges faced with these complex and relatively new techniques, and how to overcome them. 

We will cover:

  • How to approach method development for MDRS, including considerations for sample preparation, filter selection and optimisation, the number of Raman spectra to acquire, and the requirement for an orthogonal method to characterise particles < 2µm.
  • For dissolution studies, we will explore how to select the correct method (USP 2, 5 or something bespoke), including identifying the solvent system and sampling parameters that are appropriate for the drug product being tested, and consider if this test is necessary for all nasal suspension products.
  • More generally, we will comment on the expectations for method validation, and the need to perform pivotal IV-BE testing at the same site as method development and validation activities.

Why should you attend? 
Participants can expect to gain a thorough understanding of how to design and execute MDRS and dissolution studies for nasal suspension products, and how these fit more widely into formal IV-BE packages for generic submissions. 

How do you sign up?
When you register for the RDD 2024 Conference, all new registrants can select the Workshops they wish to attend during the registration process. The RDD Event Team will also send an email to all registrants with options to select their Workshops with instructions on how to sign up. Any questions? Please contact us.

Not attending RDD?
If you are unable to attend the RDD 2024 conference but would be interested in receiving the workshop presentation, please request it here:

Our team will be delighted to share the recording after the event (May 2024). 

Learn More about Intertek:
During RDD 2024, connect with our team in person to discuss all aspects of OINDP development, such as in vitro testing approaches, optimising formulation development for systemic delivery, nasal drug development, and more. Our experts will also provide updates on the commissioning of our new 20,000 sq.ft facility for the development of biologics for respiratory delivery.

Our integrated formulation and analytical teams carry out early stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing, device screening and clinical manufacturing services for all types of respiratory products. Comprehensive protein characterisation services, aligned to monitoring a protein’s structure and potency throughout formulation and storage, can also be provided.

RDD Europe 2024 will be held Tucson, Arizona. Organised by RDDOnline, the conference includes in-depth presentations and discussion of pioneering science and face-to-face networking covering all aspects of pulmonary and nasal drug delivery.

 

Learn more about our RDD Europe 2023 Workshop

RDD 2023 WORKSHOP:
How To Build An Inhaler – Navigating New Technologies For Inhaled Product Development To Meet The Ever Expanding Challenges Of Both Small And Large Molecules.

 

INTERTEK RESOURCES 
ARTICLE DOWNLOAD | Nebulised Drug Development Considerations 
ARTICLE DOWNLOAD | In Vitro Bio-equivalence For OINDP - Where are we now? 
ARTICLE DOWNLOAD |  Overcoming the Challenges of Inhaled Biologic Drug Development 
WEBINAR ON DEMAND | Formulation and Manufacturing Approaches for Nasal Drug Products 
WEBINAR ON DEMAND |  Review of In-vitro Testing for Bioequivalence of Nasal Drug Products 
BROCHURE | Intertek Inhaled Product Development Services 
BROCHURE | Inhaled Biologic Drug Development Services

 

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Intertek Melbourn Laboratory

GMP Pharmaceutical Analysis and Formulation Expertise

Intertek Melbourn
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Herts, SG8 6DN 
UK