Zdrowie i gospodarka · 04/09/2018
FDA Releases Final Guidance for Physiologically Based Pharmacokinetic Analyses
The FDA has made available a final guidance document outlining the recommended format and content for physiologically based pharmacokinetic (PBPK) analyses to support various drug applications, including INDs, NDAs, BLAs, and ANDAs.
Source: Federal Register — Food and Drug AdministrationOpen original release →