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Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1

CPT: pharmacometrics and systems pharmacology, 2021-05, Vol.10 (5), p.399-411

2021

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A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms

Journal of pharmacokinetics and pharmacodynamics, 2021-12, Vol.48 (6), p.893-908

2021

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Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

CPT: pharmacometrics and systems pharmacology, 2022-08, Vol.11 (8), p.1060-1084

2022

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Mechanistic modeling of drug products applied to the skin: A workshop summary report

CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.575-584

2023

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Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.619-623

2023

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Combination Effects of Docetaxel and Doxorubicin in Hormone-Refractory Prostate Cancer Cells

Biochemistry Research International, 2012-01, Vol.2012 (2012), p.597-606

2012

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Optimal Sampling Strategies for Irinotecan (CPT-11) and its Active Metabolite (SN-38) in Cancer Patients

The AAPS journal, 2020-03, Vol.22 (3), p.59, Article 59

2020

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Quantification of anandamide, oleoylethanolamide and palmitoylethanolamide in rodent brain tissue using high performance liquid chromatography–electrospray mass spectroscopy

Journal of pharmaceutical analysis, 2014-08, Vol.4 (4), p.234-241

2014

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Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

Clinical pharmacology and therapeutics, 2022-05, Vol.111 (5), p.1036-1049

2022

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A Phase I Study of 7-t-Butyldimethylsilyl-10-Hydroxycamptothecin in Adult Patients with Refractory or Metastatic Solid Malignancies

Clinical cancer research, 2010-01, Vol.16 (2), p.673-680

2010

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Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

The AAPS journal, 2024-04, Vol.26 (3), p.45, Article 45

2024

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Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

The AAPS journal, 2023-10, Vol.25 (6), p.96-96, Article 96

2023

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Impact of Pharmaceutical Excipients on Oral Drug Absorption: A Focus on Intestinal Drug Transporters

Clinical pharmacology and therapeutics, 2019-02, Vol.105 (2), p.323-325

2019

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Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

Journal of clinical pharmacology, 2020-12, Vol.60 (S2), p.S26-S33

2020

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Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives

Proceedings of the National Academy of Sciences - PNAS, 2020-07, Vol.117 (27), p.16009-16018

2020

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Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report

The AAPS journal, 2024-01, Vol.26 (1), p.14-14, Article 14

2024

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Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

Molecular pharmaceutics, 2022-09, Vol.19 (9), p.3139-3152

2022

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Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

The AAPS journal, 2019-02, Vol.21 (2), p.29-29, Article 29

2019

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Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses

The AAPS journal, 2016-11, Vol.18 (6), p.1500-1511

2016

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Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

AAPS PharmSciTech, 2024-02, Vol.25 (3), p.39-39, Article 39

2024

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Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein

The AAPS journal, 2021-09, Vol.23 (5), p.106-106, Article 106

2021

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Correction to: Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

AAPS PharmSciTech, 2024-04, Vol.25 (5), p.87, Article 87

2024

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Percutaneous absorption of steroids from finite doses: Predicting urinary excretion from in vitro skin permeation testing

International journal of pharmaceutics, 2022-09, Vol.625, p.122095-122095, Article 122095

2022

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Protocol for evaluation of topical ophthalmic drug products in different compartments of fresh eye tissues in a rabbit model

Journal of pharmacological and toxicological methods, 2019-03, Vol.96, p.9-14

2019

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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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Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1

A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

Mechanistic modeling of drug products applied to the skin: A workshop summary report

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

Combination Effects of Docetaxel and Doxorubicin in Hormone-Refractory Prostate Cancer Cells

Optimal Sampling Strategies for Irinotecan (CPT-11) and its Active Metabolite (SN-38) in Cancer Patients

Quantification of anandamide, oleoylethanolamide and palmitoylethanolamide in rodent brain tissue using high performance liquid chromatography–electrospray mass spectroscopy

Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations

A Phase I Study of 7-t-Butyldimethylsilyl-10-Hydroxycamptothecin in Adult Patients with Refractory or Metastatic Solid Malignancies

Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop

Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary

Impact of Pharmaceutical Excipients on Oral Drug Absorption: A Focus on Intestinal Drug Transporters

Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives

Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report

Mechanistic Modeling of In Vitro Skin Permeation and Extrapolation to In Vivo for Topically Applied Metronidazole Drug Products Using a Physiologically Based Pharmacokinetic Model

Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link—a Workshop Summary Report

Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses

Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein

Correction to: Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study

Percutaneous absorption of steroids from finite doses: Predicting urinary excretion from in vitro skin permeation testing

Protocol for evaluation of topical ophthalmic drug products in different compartments of fresh eye tissues in a rabbit model

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

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