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

European journal of pharmaceutical sciences, 2020-04, Vol.147, p.105280, Article 105280

2020

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Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets

Molecular pharmaceutics, 2016-09, Vol.13 (9), p.3256-3269

2016

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Potential for pharmaceutical excipients to impact absorption: A mechanistic review for BCS Class 1 and 3 drugs

European journal of pharmaceutics and biopharmaceutics, 2019-08, Vol.141, p.130-138

Flanagan, Talia

2019

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Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

European journal of pharmaceutical sciences, 2016-08, Vol.91, p.84-90

2016

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Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Journal of pharmaceutical sciences, 2018-01, Vol.107 (1), p.34-41

2018

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Inter-subject variability in intestinal drug solubility

International journal of pharmaceutics, 2015-05, Vol.485 (1-2), p.229-234

2015

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Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

Pharmaceutics, 2019-12, Vol.12 (1), p.19

2019

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Characterization of Aspirated Duodenal Fluids from Parkinson's Disease Patients

Pharmaceutics, 2023-04, Vol.15 (4), p.1243

2023

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Effects of ranitidine (antacid), food, and formulation on the pharmacokinetics of fostamatinib: results from five phase I clinical studies

European journal of clinical pharmacology, 2017-02, Vol.73 (2), p.185-195

2017

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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Pharmaceutics, 2022-05, Vol.14 (5), p.1010

2022

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Dissolution Universal Strategy Tool (DUST): A Tool to Guide Dissolution Method Development Strategy

Dissolution technologies, 2019-08, Vol.26 (3), p.6-16

2019

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Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants

The AAPS journal, 2020-02, Vol.22 (2), p.46-46, Article 46

2020

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Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Properties—a Global Perspective on Practices and Recommendations

The AAPS journal, 2020-03, Vol.22 (2), p.54, Article 54

2020

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Recommended strategies for the oral administration of paediatric medicines with food and drinks in the context of their biopharmaceutical properties: a review

Journal of pharmacy and pharmacology, 2017-04, Vol.69 (4), p.384-397

2017

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Patient-Centered Pharmaceutical Design to Improve Acceptability of Medicines: Similarities and Differences in Paediatric and Geriatric Populations

Drugs (New York, N.Y.), 2014-10, Vol.74 (16), p.1871-1889

2014

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Impact of Acid-Reducing Agents on Gastrointestinal Physiology and Design of Biorelevant Dissolution Tests to Reflect These Changes

Journal of pharmaceutical sciences, 2019-11, Vol.108 (11), p.3461-3477

2019

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Contribution of the Dynamic Intestinal Absorption Model (Diamod) to the Development of a Patient-Centric Drug Formulation

Molecular pharmaceutics, 2023-12, Vol.20 (12), p.6197-6212

2023

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Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts

International journal of pharmaceutics, 2016-09, Vol.511 (2), p.1151-1157

2016

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A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption

The AAPS journal, 2022-05, Vol.24 (3), p.60-60, Article 60

2022

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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Journal of pharmaceutical sciences, 2021-02, Vol.110 (2), p.594-609

2021

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Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

Journal of pharmaceutical sciences, 2021-02, Vol.110 (2), p.584-593

2021

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Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines

The AAPS journal, 2022-09, Vol.24 (6), p.101-101, Article 101

2022

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Results of an industry survey to understand current practice in bridging for paediatric formulations

International journal of pharmaceutics, 2018-02, Vol.536 (2), p.521-521

2018

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Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms

The AAPS journal, 2017-11, Vol.19 (6), p.1537-1549

2017

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

Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets

Potential for pharmaceutical excipients to impact absorption: A mechanistic review for BCS Class 1 and 3 drugs

Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

Inter-subject variability in intestinal drug solubility

Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives

Characterization of Aspirated Duodenal Fluids from Parkinson's Disease Patients

Effects of ranitidine (antacid), food, and formulation on the pharmacokinetics of fostamatinib: results from five phase I clinical studies

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

Dissolution Universal Strategy Tool (DUST): A Tool to Guide Dissolution Method Development Strategy

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants

Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Properties—a Global Perspective on Practices and Recommendations

Recommended strategies for the oral administration of paediatric medicines with food and drinks in the context of their biopharmaceutical properties: a review

Patient-Centered Pharmaceutical Design to Improve Acceptability of Medicines: Similarities and Differences in Paediatric and Geriatric Populations

Impact of Acid-Reducing Agents on Gastrointestinal Physiology and Design of Biorelevant Dissolution Tests to Reflect These Changes

In vivo methods for drug absorption – Comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects

Contribution of the Dynamic Intestinal Absorption Model (Diamod) to the Development of a Patient-Centric Drug Formulation

Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts

A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines

Results of an industry survey to understand current practice in bridging for paediatric formulations

Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms

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