相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。In Vitro Biopredictive Methods: A Workshop Summary Report
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In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium
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EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2020)
Two-step in vitro-in vivo correlations: Deconvolution and convolution methods, which one gives the best predictability? Comparison with one-step approach
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EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2020)
In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration
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Bioequivalence for highly variable drugs: regulatory agreements, disagreements, and harmonization
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In Silico Prediction of Plasma Concentrations of Fluconazole Capsules with Different Dissolution Profiles and Bioequivalence Study Using Population Simulation
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In silico Tools at Early Stage of Pharmaceutical Development: Data Needs and Software Capabilities
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AAPS PHARMSCITECH (2019)
Simultaneous Evaluation of Dissolution and Permeation of Oral Drug Solid Formulations for Predicting Absorption Rate-Limiting Factors and In Vitro-In Vivo Correlations: Case Study Using a Poorly Soluble Weakly Basic Drug
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Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles of a controlled release formulation
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EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2018)
Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded '21st Century BA/BE' project
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Establishing in vitro-in vivo correlation for antibody drug conjugate efficacy: a PK/PD modeling approach
Dhaval K. Shah et al.
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In Vitro Dissolution as a Tool for Formulation Selection: Telmisartan Two-Step IVIVC
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Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes
Vivian A. Gray
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A survey on IVIVC/IVIVR development in the pharmaceutical industry - Past experience and current perspectives
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In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context
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Predicting Pulmonary Pharmacokinetics from In Vitro Properties of Dry Powder Inhalers
Sharvari Bhagwat et al.
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Production of Irbesartan Nanocrystals by High Shear Homogenisation and Ultra-Probe Sonication for Improved Dissolution Rate
Karthik Sridhar et al.
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Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid
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EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2015)
Cocrystals of Hydrochlorothiazide: Solubility and Diffusion/Permeability Enhancements through Drug-Coformer Interactions
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Mathematical models in drug delivery: How modeling has shaped the way we design new drug delivery systems
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Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products
Avraham Yacobi et al.
PHARMACEUTICAL RESEARCH (2014)
A Pharmacokinetic Simulation Tool for Inhaled Corticosteroids
Benjamin Weber et al.
AAPS JOURNAL (2013)
Population-based meta-analysis of hydrochlorothiazide pharmacokinetics
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The role of the upper sample size limit in two-stage bioequivalence designs
Vangelis Karalis
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2013)
Mathematical modeling of drug dissolution
J. Siepmann et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2013)
Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden
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JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES (2013)
In Vitro Bioequivalence Approach for a Locally Acting Gastrointestinal Drug: Lanthanum Carbonate
Yongsheng Yang et al.
MOLECULAR PHARMACEUTICS (2013)
A Technique to Estimate In Vivo Dissolution Profiles Without Data from a Solution
Jack A. Cook
AAPS JOURNAL (2012)
On the leveling-off properties of the new bioequivalence limits for highly variable drugs of the EMA guideline
Vangelis Karalis et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2011)
Variability and Impact on Design of Bioequivalence Studies
Achiel Van Peer
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Examining the Role of Metabolites in Bioequivalence Assessment
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JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES (2010)
In Vitro Dissolution Testing with Flow-Through Method: A Technical Note
Zongming Gao
AAPS PHARMSCITECH (2009)
Computer simulations of bioequivalence trials: Selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Linear kinetics (I)
Carlos Fernandez-Teruel et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2009)
Computer simulations of bioequivalence trials: Selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Part II. Non-linear kinetics
Carlos Fernandez-Teruel et al.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2009)
Regulatory Conditions for the Determination of Bioequivalence of Highly Variable Drugs
Laszlo Endrenyi et al.
JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES (2009)
Mathematical modeling of drug delivery
J. Siepmann et al.
INTERNATIONAL JOURNAL OF PHARMACEUTICS (2008)
Bioavailability and Bioequivalence: Focus on physiological factors and variability
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PHARMACEUTICAL RESEARCH (2008)
Gastric emptying time of fluids and solids in healthy subjects determined by 13C breath tests:: influence of age, sex and body mass index
Stephan Hellmig et al.
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Population pharmacokinetics of amlodipine in hypertensive children and adolescents
Joseph T. Flynn et al.
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Modeling and comparison of dissolution profiles
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EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2001)