This live web event has ended. Thank you for attending.
Directed Raman Spectroscopy (MDRS) is an advanced
technology that combines automated particle imaging with Raman spectroscopy for
efficiently morphological characterization (e.g., particle size and shape) of individual
particles based on component-specific chemical identification. This enables a
comparison of the particle size of active pharmaceutical ingredient (API) in
the generic and innovator drug products for OINDPs, ophthalmic and transdermal products.
With the emergence of this technology and with increased number of abbreviated
new drug applications (ANDAs) being submitted to FDA, there is need to provide
clarity on the Agency’s expectations on MDRS data in support of bioequivalence
(BE) demonstration. This presentation will provide an overview of application
of MDRS technology as it relates to demonstrating BE of the generic orally
inhaled nasal drug products (OINDPs) as example. The viewpoint of BE from
the various aspects of method development and validation such as sample
preparation, and image characterization etc. will be discussed along with the
need for pivotal MDRS study to establish BE. Commonly observed deficiencies
related to MDRS in terms of method development and validation and its use in
the pivotal MDRS study will also be discussed.