Morphologically-Directed Raman Spectroscopy (MDRS) is a unique technique combining automated image analysis with Raman spectroscopy which has found key applications within bioequivalence testing of complex generics.
Complex generics often contain a combination of active and excipients in the final form. The ability of MDRS to produce component specific particle size and shape data means that you can compare physicochemical attributes between generic and reference material in place of a clinical end point study.
In this webinar we will focus on nasal sprays. The FDA draft guidance for Nasal sprays include characterisation of the drug particle size distribution by microscopy. And while you can estimate which particles are active from the image alone, this can be confirmed by adding Raman spectroscopy. Hence, an increasing number of ANDA submissions for nasal suspensions have contained MDRS data.
We will introduce how MDRS works, discuss how you might develop and validate methods for Nasal Sprays as well as reviewing recent publications.
発表者
- Dr. Robert Taylor - Marketing Segment Manager, Malvern Panalytical
- Dr. Steve Ward-Smith - Strategic Account Manager, Malvern Panalytical
詳細
Who should attend?
- Scientists and researchers developing complex generic drug products
- Anyone interested in in-vitro Bioequivalence testing
- Anyone who uses particle size and shape analysis for development of drug substances and their products
What will you learn?
- An introduction to Morphologically-Directed Raman Spectroscopy
- How Morphologically-Directed Raman Spectroscopy can be used in bioequivalence studies
- What is required of method development for MDRS in nasal sprays