FDA Critical Path Opportunity
Original Event Date: Tuesday, February 12, 2013
Duration: 1 Hour
Presenters: Tracey Safran, Senior Account Manager and Oksana Olkhovyk, PhD, Senior Scientist at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical
Highlighted Topics Covered:
- What the FDA critical path opportunity is for generic nasal spray suspensions
- How Gateway Analytical's method for drug particle sizing can address this critical path opportunity
- Why this service has the potential to save generic drug manufacturers a considerable amount of time and money
- Provide information on Gateway Analytical's process for addressing the critical path opportunity
- The importance of using a cGMP certified lab for quality control and assurance
Webinar Overview:
The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions. The critical path opportunity is to develop methods to measure drug particle size in a suspension product with sufficient accuracy and precision so that in vivo biostudies can be waived.”
This webinar was designed for generic drug manufacturers of nasal spray suspensions. During this webinar, our presenters discussed how the method of Ingredient-Specific Particle Sizing (ISPS) using Raman Chemical Imaging (RCI) developed by Gateway Analytical, can address the critical path opportunity by providing the accurate and precise drug particle size measurement to demonstrate bioequivalence. This service offering has the potential to save considerable time and money for generic nasal spray suspension developers if in vivo biostudies are waived.
The presenters also provided information on Gateway Analytical's process for addressing the critical path opportunity; outlining the development of the feasibility study, writing and implementing the validation protocol, and the sample size needed for analysis as required by the FDA. The importance of using a cGMP certified lab for quality control and assurance was also be discussed.
Presenter Bios:
Tracey Safran
Tracey Safran, Senior Account Manager
Gateway Analytical
Tracey joined Gateway Analytical at its inception in November of 2010 transferring her skills from the parent company, ChemImage Corporation where she began in 2003. She is responsible for the account management of clients in need of analytical testing for pharmaceuticals, specifically for ingredient-specific particle sizing using Raman Chemical Imaging for nasal, inhalation, and semi-solids drug products.
Tracey is very active in the pharmaceutical community, interacting with various organizations which expose her to new advancements in inhalation and nasal technology methods. Through these interactions, she is able to guide clients to the best solution for their analytical testing needs.
Oksana Olkhovyk
Oksana Olkhovyk, PhD, Senior Scientist
Gateway Analytical
Oksana is a lead scientist for analytical services involving nasal, inhalation, and semi-solid drug products at Gateway Analytical such as ingredient-specific particle sizing analysis, polymorph identification and content uniformity. Oksana is managing a chemical imaging laboratory that specializes in chemical-specific analysis of pharmaceutical products by high-resolution microscopy, SEM-EDS, hyperspectral and confocal chemical imaging, spectroscopy, FT-IR and other GMP-compliant analytical methods.
Oksana's primary responsibilities include project management, instrument quality and standardization, method development and validation, customer communications and technical support, scientific collaborations between Gateway Analytical and leading academic entities and pharmaceutical companies.
Please note: We had some technical issues with the sound in the beginning of the webinar, which were resolved shortly after the start of the webinar. If you have any questions, please feel free to contact us