Scientific and Regulatory Considerations of Applying Morphologically Directed Raman Spectroscopy in Bioequivalence Assessment for Generic Orally Inhaled Nasal Drug Products

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Description

Morphologically 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.

Contributors

Prakash Bhagav, Ph.D.

Dr. Prakash Bhagav joined the Division of Bioequivalence III (DBIII) in 2015 and has primarily been involved in the assessment of bioequivalence (BE) data submitted in Abbreviated New Drug Applications (ANDAs). He is involved in the BE assessment of various drug products including oral products, nasal suspensions, ophthalmic emulsions, locally acting products, complex topical products, etc. He is part of several working groups within FDA including working group for bioanalytical guidances. He received his Bachelor degree in Pharmaceutical Sciences and Masters in Pharmacy with specialization in Pharmaceutics from Bangalore, India and Ph. D in Pharmaceutical Sciences from BITS, Pilani India. He was a Postdoctoral Research Fellow in Pharmaceutics and Drug Delivery from the University of Mississippi, School of Pharmacy, Oxford, Mississippi.
Nicholas Holtgrewe, Ph.D.

Dr. Nicholas Holtgrewe has been a Chemist at the FDA Division of Complex Drug Analysis (DCDA) within CDER/OPQ/OTR since April 2019. His research at FDA focuses on inhalation drug characterization, particle sizing, X-ray powder diffraction (XRPD), and spectroscopy and his expertise is in optics, X-ray diffraction, and Raman spectroscopy. He received a BS degree in Chemistry from Truman State University in 2008 and a PhD degree in Chemistry from Washington University in St. Louis in 2013.
Changning Guo, Ph.D. (Panelist)

Dr. Changning Guo has been working for FDA since 2004. He is a supervisory chemist and serves as the lab chief in the Division of Complex Drug Analysis (DCDA) Branch II within CDER/OPQ/OTR. His research at FDA focus on inhalation drug characterization, particle sizing, X-ray powder diffraction (XRPD), and spectroscopy. He has been a PI/co-PI on multiple FDA research projects and served as a subject matter expert for FDA working groups, guidance teams, ANDA review teams, and FDA research grant review committees. He received a BS degree in Chemistry from Tsinghua University and a PhD degree in Analytical Chemistry from Syracuse University.
Ke Ren, Ph.D. (Panelist)

Dr. Ke Ren is the currently an acting Deputy Director in the Division of Bioequivalence III (DBIII) in the Office of Bioequivalence of Office of Generic Drugs, CDER, FDA. In this role, she leads a team of scientists responsible for the assessment of the bioequivalence section of Abbreviated New Drug Applications. During her time in DBIII, Dr. Ke Ren has developed extensive expertise in generic drug development in various therapeutic areas, including orally inhaled and nasal drug products. She has participated in the drafting of numerous Agency guidances pertaining to bioequivalence. Dr. Ren received her Ph.D. in Pharmaceutical Science from the University of Florida in 2005 and then undertook post-doctoral training at the University of Florida before joining OGD in 2008.

Thank you

Description

Contributors

Prakash Bhagav, Ph.D.

Nicholas Holtgrewe, Ph.D.

Changning Guo, Ph.D. (Panelist)

Ke Ren, Ph.D. (Panelist)