This presentation examines SEM-EDS and Raman Spectroscopy as a means to accelerate generic drug applications. Presented on October 2017 at the 6th Medicon Valley Inhalation Symposium (MVIC) by Julie D. Suman, PhD.
This presentation examines global regulatory requirements along with regulatory approaches for bioequivalence and an overview of FDA drug specific guidance.
This presentation examines regulatory approaches for bioequivalence and a comparison of compendial testing and pharmaceutical equivalence for Brazil.
This presentation gives perspective to understanding the rationale for nasal and pulmonary drug delivery and provides guidance for differentiating between device attributes for inhalation and nasal platforms.
Presented at RDD EUROPE 2015, this presentation takes a critical look at delivery systems and their life cycle management, including looking at the benefits and challenges.
This presentation examines OINDP container closure system attributes and reviews the requirements of extractables and leachables.