PMID- 35299768
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231105
IS  - 1848-7718 (Print)
IS  - 1848-7718 (Electronic)
IS  - 1848-7718 (Linking)
VI  - 9
IP  - 2
DP  - 2021
TI  - Lost in modelling and simulation?
PG  - 75-109
LID - 10.5599/admet.923 [doi]
AB  - Over the past few decades, physiologically-based pharmacokinetic modelling (PBPK) 
      has been anticipated to be a powerful tool to improve the productivity of drug 
      discovery and development. However, recently, multiple systematic evaluation 
      studies independently suggested that the predictive power of current oral 
      absorption (OA) PBPK models needs significant improvement. There is some 
      disagreement between the industry and regulators about the credibility of OA PBPK 
      modelling. Recently, the editorial board of AMDET&DMPK has announced the policy 
      for the articles related to PBPK modelling (Modelling and simulation ethics). In 
      this feature article, the background of this policy is explained: (1) 
      Requirements for scientific writing of PBPK modelling, (2) Scientific literacy 
      for PBPK modelling, and (3) Middle-out approaches. PBPK models are a useful tool 
      if used correctly. This article will hopefully help advance the science of OA 
      PBPK models.
CI  - Copyright (c) 2021 by the authors.
FAU - Sugano, Kiyohiko
AU  - Sugano K
AD  - Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan 
      University, 1-1-1, Noji-higashi, Kusatsu, Shiga 525-8577, Japan.
LA  - eng
PT  - Journal Article
DEP - 20210322
PL  - Croatia
TA  - ADMET DMPK
JT  - ADMET & DMPK
JID - 101660124
PMC - PMC8920108
OTO - NOTNLM
OT  - middle-out approach
OT  - physiologically-based pharmacokinetic modelling
OT  - reproducibility
OT  - scientific literacy
OT  - structural identifiability
OT  - transparency
COIS- Conflict of interest Kiyohiko Sugano is the founder of BioavailabilityDesign LLC.
EDAT- 2022/03/19 06:00
MHDA- 2022/03/19 06:01
PMCR- 2021/03/22
CRDT- 2022/03/18 05:09
PHST- 2021/11/06 00:00 [received]
PHST- 2021/03/05 00:00 [revised]
PHST- 2022/03/18 05:09 [entrez]
PHST- 2022/03/19 06:00 [pubmed]
PHST- 2022/03/19 06:01 [medline]
PHST- 2021/03/22 00:00 [pmc-release]
AID - 10.5599/admet.923 [doi]
PST - epublish
SO  - ADMET DMPK. 2021 Mar 22;9(2):75-109. doi: 10.5599/admet.923. eCollection 2021.