FDA’s New ANDA Submissions Guidance: Key Points Blog FDA’s New ANDA Submissions Guidance: Key Points The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…Certara2018 年 9 月 27 日
How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs On-Demand Webinar How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin…Danielle Pillsbury2018 年 9 月 25 日