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

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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.

July 21, 2022
Thu 12:30 PM EDT

Duration 1H 30M

This live web event has ended.

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