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SEM-EDS and Raman Spectroscopy to Accelerate Generic Drug Applications
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.
An Innovative Strategy for Nasal Spray Bioequivalence for Biowaivers
This poster focuses on the utilization of the SPE© automated Raman spectroscopy system and its ability to measures the count, size and shape of particles, and chemical characterization.
Understanding Global Regulatory Requirements for Nasal Drug Products
This presentation examines global regulatory requirements along with regulatory approaches for bioequivalence and an overview of FDA drug specific guidance.
Adapting Pharmacopeial Testing for Pharmaceutical Equivalence Studies
This presentation examines regulatory approaches for bioequivalence and a comparison of compendial testing and pharmaceutical equivalence for Brazil.
Nasal Spray Bioequivalence – In Vitro Test Study Plan
This document provides a sample outline of a model suspension nasal spray product program designed to meet expected storage, experiment and report expectations for regulatory submission.
Inhalation & Nasal Device Overview
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.
Leveraging Old Drugs: A Critical Review of Delivery Systems and Life Cycle Management
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.
Nasal Spray – Stability and Batch Release Testing
This document provides a sample outline of a model suspension nasal spray product program designed to meet expected storage, experiment and report expectations for regulatory submission.
Qualifying Container Closure Systems for OINDP: Current & Future Regulatory Expectations
This presentation examines OINDP container closure system attributes and reviews the requirements of extractables and leachables.