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Gateway Analytical, in partnership with Next Breath, will present an OINDP Webinar Series for Dry Powder Inhalers (DPIs), pressurized Metered Dose Inhalers (MDIs), and Nasal Drug Products. The first in the series, In-Depth Characterizations of OINDPs from R&D to Regulatory Submission, will take place on Wednesday, October 14, 2015.
The first in a series of four webinars, presented jointly by Gateway Analytical and Next Breath, will offer attendees insight into utilization of ingredient specific particle sizing (ISPS) to support formulation development, API and excipient selection establishing qualitative and quantitative sameness (Q&Q) and minimizing risk of clinical trials failures via pre-bioequivalence studies. The webinar will be presented jointly by Dr. Oksana Olkhovyk, Senior Scientist at Gateway Analytical, and Dr. Julie Suman, co-founder and President of Next Breath, LLC.
"Establishing and proving bioequivalence of inhaled combination therapies can be difficult without accurately and precisely measuring the particle size distribution of individual active pharmaceutical ingredients and source determination of any foreign particulate matter," said Dr. Oksana Olkhovyk. "During this webinar, we will discuss the utilization of ingredient specific particle sizing (ISPS) to support formulation development, API and excipient selection."
The presentation will pay special attention to 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. The webinar will also highlight specific risk mitigating strategies for CMC-required tests.
"As the FDA continues to issue drug product specific bioequivalence guidances, the role of analytical tests for these dosage forms play a critical role in these applications," said Dr. Julie Suman. "This webinar will illustrate study design and data analysis techniques to maximize a positive bioequivalence outcome."
Anyone involved in guaranteeing the development, quality and safety from R&D to regulatory submission for Nasal Drug Product Development delivery systems is encouraged to attend this webinar presentation. For more information about the webinar or to register online, please visit Gateway Analytical.
About Gateway Analytical
Based in Gibsonia, Pa., Gateway Analytical, LLC (gatewayanalytical.com) is a full service, FDA registered and inspected laboratory with specialized expertise in techniques for chemically specific particle sizing and particulate contamination identification. The lab is cGMP compliant, following 21 CFR parts 210 & 211, 21 CFR part 820, and ICH Q7. Accreditations include ISO 9001:2008, ISO 17025:2005, and ASCLD/LAB-International.
Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.
About Next Breath
Next Breath, LLC (nextbreath.net), a subsidiary of AptarGroup, is a cGMP specialty Contract Research Organization (CRO) with analytical expertise for pharmaceutical, biotechnology, and consumer health product development focused on pulmonary, nasal, topical and ophthalmic delivery systems. Next Breath provides comprehensive solutions to the development processes from proof of concept to commercialization. Next Breath has led successful submissions for pulmonary and nasal drug products and devices in the US and international markets.
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