Exploring Product Specific Guidances Webinar Opening Remarks
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- Mitchell Frost from CDER's Office of Generic Drugs discusses study population and terminology, bioequivalence studies with ...
- Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote
- Rob Lionberger, Lei Zhang, CDR Christine Le, Myong-Jin Kim, Markham Luke, Mitchell Frost, Paramjeet Kaur, David Coppersmith ...
- Opening remarks
- Hirten Patel, PhD, Staff Fellow from the Division of Bioequivalence II (DB-II) presents the Practical Considerations Related to IVPT ...
In-Depth Information on Product Specific Guidances Webinar Opening Remarks
Lei Zhang, Deputy Director of the Office of Research and Standards in FDA's Office of Generic Drugs, explains Director of the Office of Research and Standards (ORS) Robert Lionberger in the Office of Generic Drugs at CDER provides ... Lanyan (Lucy) Fang, PhD-FDA Gabriel Innes, VMD, PhD-FDA Luis Pinheiro, PharmD, MEpi-European Medicines Agency Robert ... The purpose of this
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