Turnitin
降AI改写
早检测系统
早降重系统
Turnitin-UK版
万方检测-期刊版
维普编辑部版
Grammarly检测
Paperpass检测
checkpass检测
PaperYY检测
In silico modeling and simulation to guide bioequivalence testing for oral drugs in a virtual population
Abstract Model-informed drug discovery and development (MID3) shows great advantages
in facilitating drug development. A physiologically based pharmacokinetic model is one of …
in facilitating drug development. A physiologically based pharmacokinetic model is one of …
The discriminatory power of the BCS-based biowaiver: a retrospective with focus on essential medicines
This article summarizes historic developments, recent expert opinions, and (currently)
unresolved challenges concerning the Biopharmaceutics Classification System (BCS) …
unresolved challenges concerning the Biopharmaceutics Classification System (BCS) …
PBPK Absorption Modeling: Establishing the In Vitro–In Vivo Link—Industry Perspective
C Stillhart, X Pepin, C Tistaert, D Good… - The AAPS Journal, 2019 - Springer
The establishment of an in vitro–in vivo correlation (IVIVC) is considered the gold standard
to establish in vivo relevance of a dissolution method and to utilize dissolution data in the …
to establish in vivo relevance of a dissolution method and to utilize dissolution data in the …
Mechanistic investigation of the negative food effect of modified release zolpidem
CJ Andreas, X Pepin, C Markopoulos… - European journal of …, 2017 - Elsevier
Aims When administered orally as either an immediate or modified release dosage form,
zolpidem demonstrates a negative food effect, ie decrease in C max and AUC. The aim of …
zolpidem demonstrates a negative food effect, ie decrease in C max and AUC. The aim of …
[HTML][HTML] Bicarbonate buffer dissolution test with gentle mechanistic stress for bioequivalence prediction of enteric-coated pellet formulations
S Ikuta, H Nakagawa, T Kai, K Sugano - European Journal of …, 2024 - Elsevier
This study aimed to develop a dissolution test that can predict the bioequivalence (BE) of
enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference …
enteric-coated pellet formulations. The original duloxetine hydrochloride capsule (reference …
In vitro biopredictive methods: a workshop summary report
This workshop report summarizes the proceedings of Day 1 of a three-day workshop on
“Current State and Future Expectations of Translational Modeling Strategies to Support Drug …
“Current State and Future Expectations of Translational Modeling Strategies to Support Drug …
Utilization of gastrointestinal simulator, an in vivo predictive dissolution methodology, coupled with computational approach to forecast oral absorption of dipyridamole
Weakly basic drugs exhibit a pH-dependent dissolution profile in the gastrointestinal (GI)
tract, which makes it difficult to predict their oral absorption profile. The aim of this study was …
tract, which makes it difficult to predict their oral absorption profile. The aim of this study was …
[HTML][HTML] Bioequivalence dissolution test criteria for formulation development of high solubility-low permeability drugs
A Ono, R Kurihara, K Terada… - Chemical and …, 2023 - jstage.jst.go.jp
The purpose of the present study was to provide the experimental and theoretical basis of
bioequivalence (BE) dissolution test criteria for formulation development of high solubility …
bioequivalence (BE) dissolution test criteria for formulation development of high solubility …
Lowly-buffered biorelevant dissolution testing is not necessarily biopredictive of human bioequivalence study outcome: Relationship between dissolution and …
It has been revealed that buffer capacity of aspirated human intraluminal fluid is much lower
than that of in vitro compendial dissolution media. Since buffer capacity significantly alters …
than that of in vitro compendial dissolution media. Since buffer capacity significantly alters …
Implementing the biopharmaceutics classification system in drug development: reconciling similarities, differences, and shared challenges in the EMA and US-FDA …
The US-FDA recently posted a draft guideline for industry recommending procedures
necessary to obtain a biowaiver for immediate-release oral dosage forms based on the …
necessary to obtain a biowaiver for immediate-release oral dosage forms based on the …