PMID- 33220025
OWN - NLM
STAT- MEDLINE
DCOM- 20211216
LR  - 20211216
IS  - 2163-8306 (Electronic)
IS  - 2163-8306 (Linking)
VI  - 10
IP  - 1
DP  - 2021 Jan
TI  - Examination of Physiologically-Based Pharmacokinetic Models of Rosuvastatin.
PG  - 5-17
LID - 10.1002/psp4.12571 [doi]
AB  - Physiologically-based pharmacokinetic (PBPK) modeling is increasingly used to 
      predict drug disposition and drug-drug interactions (DDIs). However, accurately 
      predicting the pharmacokinetics of transporter substrates and 
      transporter-mediated DDIs (tDDIs) is still challenging. Rosuvastatin is a 
      commonly used substrate probe in DDI risk assessment for new molecular entities 
      (NMEs) that are potential organic anion transporting polypeptide 1B or breast 
      cancer resistance protein transporter inhibitors, and as such, several 
      rosuvastatin PBPK models have been developed to try to predict the clinical DDI 
      and support NME drug labeling. In this review, we examine five representative 
      PBPK rosuvastatin models, discuss common challenges that the models have come 
      across, and note remaining gaps. These shared learnings will help with the 
      continuing efforts of rosuvastatin model validation, provide more information to 
      understand transporter-mediated drug disposition, and increase confidence in tDDI 
      prediction.
CI  - (c) 2020 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by 
      Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology 
      and Therapeutics.
FAU - Bowman, Christine M
AU  - Bowman CM
AD  - Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San 
      Francisco, California, USA.
FAU - Ma, Fang
AU  - Ma F
AD  - Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San 
      Francisco, California, USA.
FAU - Mao, Jialin
AU  - Mao J
AD  - Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San 
      Francisco, California, USA.
FAU - Chen, Yuan
AU  - Chen Y
AD  - Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., South San 
      Francisco, California, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20201215
PL  - United States
TA  - CPT Pharmacometrics Syst Pharmacol
JT  - CPT: pharmacometrics & systems pharmacology
JID - 101580011
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
SB  - IM
MH  - Animals
MH  - Computer Simulation
MH  - Drug Interactions
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*pharmacokinetics
MH  - *Models, Biological
MH  - Rosuvastatin Calcium/*pharmacokinetics
PMC - PMC7825190
COIS- The authors declared no competing interests for this work.
EDAT- 2020/11/22 06:00
MHDA- 2021/12/17 06:00
PMCR- 2021/01/01
CRDT- 2020/11/21 12:07
PHST- 2020/08/05 00:00 [received]
PHST- 2020/10/19 00:00 [accepted]
PHST- 2020/11/22 06:00 [pubmed]
PHST- 2021/12/17 06:00 [medline]
PHST- 2020/11/21 12:07 [entrez]
PHST- 2021/01/01 00:00 [pmc-release]
AID - PSP412571 [pii]
AID - 10.1002/psp4.12571 [doi]
PST - ppublish
SO  - CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):5-17. doi: 10.1002/psp4.12571. 
      Epub 2020 Dec 15.