Computational approaches in preclinical studies on drug discovery and development

F Wu, Y Zhou, L Li, X Shen, G Chen, X Wang… - Frontiers in …, 2020 - frontiersin.org
Because undesirable pharmacokinetics and toxicity are significant reasons for the failure of
drug development in the costly late stage, it has been widely recognized that drug ADMET …

Computational pharmaceutics-A new paradigm of drug delivery

W Wang, Z Ye, H Gao, D Ouyang - Journal of Controlled Release, 2021 - Elsevier
In recent decades pharmaceutics and drug delivery have become increasingly critical in the
pharmaceutical industry due to longer time, higher cost, and less productivity of new …

Applications, challenges, and outlook for PBPK modeling and simulation: a regulatory, industrial and academic perspective

W Lin, Y Chen, JD Unadkat, X Zhang, D Wu… - Pharmaceutical …, 2022 - Springer
Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

Physiologically based pharmacokinetic modeling in regulatory science: an update from the US Food and Drug Administration's Office of Clinical Pharmacology

M Grimstein, Y Yang, X Zhang, J Grillo… - Journal of …, 2019 - Elsevier
This commentary provides an update on the status of physiologically based pharmacokinetic
modeling and simulation at the US Food and Drug Administration's Office of Clinical …

[HTML][HTML] Recent advances in carrier mediated nose-to-brain delivery of pharmaceutics

V Bourganis, O Kammona, A Alexopoulos… - European Journal of …, 2018 - Elsevier
Central nervous system (CNS) disorders (eg, multiple sclerosis, Alzheimer's disease, etc.)
represent a growing public health issue, primarily due to the increased life expectancy and …

[HTML][HTML] Impact of gastrointestinal physiology on drug absorption in special populations––An UNGAP review

C Stillhart, K Vučićević, P Augustijns, AW Basit… - European Journal of …, 2020 - Elsevier
The release and absorption profile of an oral medication is influenced by the
physicochemical properties of the drug and its formulation, as well as by the anatomy and …

Physiologically based pharmacokinetic model qualification and reporting procedures for regulatory submissions: a consortium perspective

M Shebley, P Sandhu… - Clinical …, 2018 - Wiley Online Library
This work provides a perspective on the qualification and verification of physiologically
based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based …

[HTML][HTML] PBPK modeling and simulation in drug research and development

X Zhuang, C Lu - Acta Pharmaceutica Sinica B, 2016 - Elsevier
Physiologically based pharmacokinetic (PBPK) modeling and simulation can be used to
predict the pharmacokinetic behavior of drugs in humans using preclinical data. It can also …

Intestinal permeability and drug absorption: predictive experimental, computational and in vivo approaches

D Dahlgren, H Lennernäs - Pharmaceutics, 2019 - mdpi.com
The main objective of this review is to discuss recent advancements in the overall
investigation and in vivo prediction of drug absorption. The intestinal permeability of an …

Applied concepts in PBPK modeling: how to build a PBPK/PD model

L Kuepfer, C Niederalt, T Wendl… - CPT …, 2016 - Wiley Online Library
The aim of this tutorial is to introduce the fundamental concepts of physiologically based
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling with a special focus on their …