Establishment of Dissolution Acceptance Criterion Using In Silico Physiologically Based Pharmacokinetics (PBPK) Modelling and Simulation

2016 ◽  
Author(s):  
John Duan
Keyword(s):  
In Silico ◽  
Modelling And Simulation ◽  
Physiologically Based Pharmacokinetics ◽  
Pbpk Modelling ◽  
Acceptance Criterion ◽  
Physiologically Based

scholarly journals Physiologically Based Pharmacokinetics Model in Pregnancy: A Regulatory Perspective on Model Evaluation

2021 ◽  
Vol 9 ◽  
Author(s):  
Paola Coppola ◽  
Essam Kerwash ◽  
Susan Cole
Keyword(s):  
Model Evaluation ◽  
Pharmacokinetic Data ◽  
Physiological Changes ◽  
Physiologically Based Pharmacokinetics ◽  
Predictive Tool ◽  
Pbpk Modelling ◽  
Age Related ◽  
Physiologically Based ◽  
Regulatory Submissions ◽  
In Pregnancy

Physiologically based pharmacokinetics (PBPK) modelling is widely used in medicine development and regulatory submissions. The lack of clinical pharmacokinetic data in pregnancy is widely acknowledged; therefore, one area of current interest is in the use of PBPK modelling to describe the potential impact of anatomical and physiological changes during pregnancy on the medicine's pharmacokinetics. PBPK modelling could possibly represent a predictive tool to support the medicine benefit–risk decision and inform dose adjustment in this population and also to investigate medicine levels in the foetus to support the risk assessment to the foetus. In the context of regulatory application, there are, however, a number of considerations around model evaluation, and this should be tailored to the model purpose, in order to inform the confidence in the model for the intended application. A number of gestational age-related physiological changes are expected to alter the pharmacokinetics of medicines during pregnancy, and there are uncertainties on some parameters; therefore, well-qualified models are needed to improve assurance in the model prediction before this approach can be used to inform with confidence high-impact decisions as part of regulatory submissions.

Physiologically based pharmacokinetics of digoxin in mdr1a knockout mice

1999 ◽  
Vol 88 (12) ◽  
pp. 1281-1287 ◽  
Author(s):  
Masami Kawahara ◽  
Atsushi Sakata ◽  
Toshiaki Miyashita ◽  
Ikumi Tamai ◽  
Akira Tsuji
Keyword(s):  
Knockout Mice ◽  
Physiologically Based Pharmacokinetics ◽  
Physiologically Based
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