First in Human (FIH) PBPK predictions

0:00 Introduction in Chinese
3:15 Neil Miller begins lecture
4:08 What is PBPK?
8:00 What is PBPK not
8:31 How is PBPK used?
30:40 Case Study 1
34:40 Case Study 2
39:16 Take Home Message
42:15 Q&A Section
52:50 Live Q&A

An overview of what PBPK is will be provided so that everyone starts from the same level. How PBPK is used will be discussed with a particular focus on FIH PK predictions. Key components of a FIH PK prediction for oral administration will be reviewed: absorption, distribution, metabolism and elimination, plus uncertainty analysis. We will finish with case studies highlighting where PBPK was used to avoid a clinical study and how human efficacious doses can be predicted.