Utility of physiologically based absorption modeling in implementing Quality by Design in drug development
about
The use of modeling tools to drive efficient oral product designCase studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data.Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound.Simulation of the pharmacokinetics of bisoprolol in healthy adults and patients with impaired renal function using whole-body physiologically based pharmacokinetic modeling.Physiologically based absorption modelling to predict the impact of drug properties on pharmacokinetics of bitopertin.Application of absorption modeling to predict bioequivalence outcome of two batches of etoricoxib tablets.Application of Physiologically Based Absorption Modeling to Characterize the Pharmacokinetic Profiles of Oral Extended Release Methylphenidate Products in AdultsAssessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling.Application of quality by design to the process development of botanical drug products: a case study.An update on computational oral absorption simulation.PBPK as a tool in regulatory review.A case study of in silico modelling of ciprofloxacin hydrochloride/metallic compound interactionsPhysiologically-based pharmacokinetic models: approaches for enabling personalized medicine.Incorporation of stochastic variability in mechanistic population pharmacokinetic models: handling the physiological constraints using normal transformations.Integrating In Vitro, Modeling, and In Vivo Approaches to Investigate Warfarin Bioequivalence.Use of preclinical dog studies and absorption modeling to facilitate late stage formulation bridging for a BCS II drug candidate.Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm.Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public WorkshopPrediction of a Therapeutic Dose for Buagafuran, a Potent Anxiolytic Agent by Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling Starting from Pharmacokinetics in Rats and Human.Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.Predictive Performance of Physiologically Based Pharmacokinetic Models for the Effect of Food on Oral Drug Absorption: Current Status.Assessing bioequivalence of generic antiepilepsy drugs.
P2860
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P2860
Utility of physiologically based absorption modeling in implementing Quality by Design in drug development
description
2011 nî lūn-bûn
@nan
2011 թուականի Յունուարին հրատարակուած գիտական յօդուած
@hyw
2011 թվականի հունվարին հրատարակված գիտական հոդված
@hy
2011年の論文
@ja
2011年論文
@yue
2011年論文
@zh-hant
2011年論文
@zh-hk
2011年論文
@zh-mo
2011年論文
@zh-tw
2011年论文
@wuu
name
Utility of physiologically bas ...... by Design in drug development
@ast
Utility of physiologically bas ...... by Design in drug development
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type
label
Utility of physiologically bas ...... by Design in drug development
@ast
Utility of physiologically bas ...... by Design in drug development
@en
prefLabel
Utility of physiologically bas ...... by Design in drug development
@ast
Utility of physiologically bas ...... by Design in drug development
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P2860
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Utility of physiologically bas ...... by Design in drug development
@en
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Barbara M Davit
Lawrence X Yu
Robert A Lionberger
Xinyuan Zhang
P2860
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P356
10.1208/S12248-010-9250-9
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P577
2011-01-05T00:00:00Z
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P6179
1001621305