In-depth characterizations of OINDPs from R&D to regulatory submission

October 15, 2015

Next Breath and Gateway Analytical will present their OINDP Webinar Series for Dry powder Inhalers (DPIs), pressurized Metered Dose Inhaler (MDIs), and Nasal drug products which are complex delivery systems and their development require key specialized expertise. Next Breath and Gateway analytical are pleased to present a webinar to provide a comprehensive review of their in-house analytical technologies, GMP methods, and specialized expertise. The webinar will cover in-depth characterizations of OINDPs from R&D stage to regulatory submission of these delivery’s systems. Special attention will be given to describe collaborative expert support that both companies can provide to reduce risk of clinical trials, mitigate device failure and drive timelines to get the product to market.

Highlighted Topics Include

  • Utilization of ISPS to support formulation development, API and excipient selection
  • Establishing qualitative and quantitative sameness (Q&Q)
  • Minimizing risk of clinical trials failures via pre-bioequivalence studies
  • Stability study design including particulates analysis
  • Techniques and methods for identification of foreign particulates
  • ANDAs and NDAs: lessons learned from past OINDPs submissions

Specifically, the webinar will present practical use of ingredient-specific particle sizing (ISPS) and foreign particulate matter analysis in container closure screening, API/excipients selection, deformulation support, and stability studies. In addition, the webinar will clarify the most recent OINDPs regulatory guidances and their impact on NDA and ANDAs submissions. Finally, the webinar will be wrapped up by highlighting specific risk mitigating strategies for CMC required tests.

Who Should Attend?

You should attend this webinar if you are involved in guaranteeing the development, quality and safety from R&D to regulatory submission for Nasal Drug Product Development delivery systems.

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