Recently, the American Association of Pharmaceutical Scientists (AAPS) released a post on their blog authored by Binodh DeSilva, Executive Director of Immunochemistry and Biomarker Development and Mark E. Arnold, Ph.D., Executive Director of the Bioanalytical Sciences and Selective Integration Department at Bristol Myer Squibb on the FDA and industry discussing crucial draft bioanalytical method validation guidance. Here is an excerpt from the post:
Recently on December 22nd, Dave Exline, Senior V.P. at Gateway Analytical stopped by the Pittsburgh Technology Council’s TechVibe Radio to talk on-air with Audrey Russo and Jonathan Kersting about Gateway Analytical and its services.
Gateway Analytical will be offering a new webinar series for scientists, focused on chemical imaging, June though September of this year. This webinar series is designed for scientists developing and manufacturing various types of pharmaceutical products; including nasal, inhalation, semi-solid, solid, and controlled release drug delivery.
This year at Respiratory Drug Delivery 2012, Dr. Oksana Olkhovyk will be presenting a poster with Christopher Vernall from the University of Bath which is located in the UK. This year’s poster topic, titled: “Investigation of the Microstructure of Combination Dry Powder Inhaler Formulations by Atomic Force Microscopy and Raman Chemical Imaging”, aims to investigate the microstructure of commercial Seretide® Accuhaler® using RCI and the cohesive-adhesive balance (CAB) approach to colloid probe AFM.
On April 25th, 2012 we hosted a live webinar titled “Laboratory Methods for the Examination of Foreign Particulate Matter.” During the webinar our presenters, David Exline, Senior V.P. and Antonio Scatena, Scientist at Gateway Analytical, discussed current methods of particulate isolation, laboratory testing methods for identifying foreign particulates and the company's forensic approach to source determination. During the webinar we received a number of questions, below is a sample of the Q&A session at the end of the webinar.
In 2004, the FDA launched the Critical Path Initiative as a national strategy to drive innovation in development, evaluation and manufacturing of medical products1. As part of this initiative, the FDA identified a number of Critical Path Opportunities (CPOs) for generic drugs. Namely the CPO for Bioequivalence of Nasal Sprays, which identifies a need for direct measurement of particle size equivalence in suspension nasal sprays2.