Best Practices for Topical Generic Product Development & ANDA Submission–Session 3, Closing Remarks

Hirten Patel, PhD, Staff Fellow from the Division of Bioequivalence II (DB-II) presents the Practical Considerations Related to IVPT Studies for Topical Products Submitted in ANDAs. After this presentation, the Q&A panel has a discussion on the IVPT Studies with Topical Products moderated by Priyanka Ghosh, PhD, Acting Team Lead from the Division of Topical Products (DTP-I) with Usha Katragadda, PhD, Staff Fellow from the Division of Bioequivalence II (DB-II), Archana Manerikar, MS, PharmD, Pharmacologist from the Division of Bioequivalence I (DB-I), Hiren Patel, PhD, Staff Fellow from the Division of Bioequivalence II (DB-II), Sam Raney, PhD, Associate Director for Science of the Office of Research and Standards (ORS), and Elena Rantou, PhD, Lead Mathematical Statistician from the Division of Biostatistics VIII (DB-VIII). Priyanka Ghosh, PhD, Acting Team Lead from the Division of Topical Products (DTP-I) ends webinar with the closing remarks.

Timestamps

01:17 – Practical Considerations Related to IVPT Studies for Topical Products Submitted in ANDAs

27:22 – Q&A Panel on IVPT Studies with Topical Products

56:35 – Closing Remarks

SPEAKERS:

Hiren Patel, PhD
Staff Fellow
DB-II | OB | OGD | FDA

Priyanka Ghosh, PhD
Acting Team Lead
DTP-I | ORS | OGD | FDA

FDA PANELISTS:

Moderator:
Priyanka Ghosh, PhD
Acting Team Lead
DTP-I | ORS | OGD | FDA

Usha Katragadda, PhD
Staff Fellow
DB-II | OB | OGD | FDA

Archana Manerikar, MS, PharmD
Pharmacologist
DB-I | OB | OGD | FDA

Hiren Patel, PhD
Staff Fellow
DB-II | OB | OGD | FDA

Sam Raney, PhD
Associate Director for Science
ORS | OGD | FDA

Elena Rantou, PhD
Lead Mathematical Statistician
DB-VIII | OB* | OTS | FDA

Learn more at: Best Practices for Topical Generic Product Development and ANDA Submission - 08/11/2022 | FDA

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