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

Mark Donnelly; Eleftheria Tsakalozou; Satish Sharan; Thomas Straubinger; Robert Bies; Liang Zhao

doi:10.1002/jcph.1760

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

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1760 ◽

2020 ◽

Vol 60 (S2) ◽

Author(s):

Mark Donnelly ◽

Eleftheria Tsakalozou ◽

Satish Sharan ◽

Thomas Straubinger ◽

Robert Bies ◽

...

Keyword(s):

Reproductive Tract ◽

Generic Drugs ◽

Pharmacokinetic Modeling ◽

Female Reproductive Tract ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Regulatory Decisions

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Evaluating the Role of Solubility in Oral Absorption of Poorly Water‐Soluble Drugs Using Physiologically‐Based Pharmacokinetic Modeling

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1672 ◽

2019 ◽

Vol 107 (3) ◽

pp. 650-661 ◽

Cited By ~ 1

Author(s):

Christina Fink ◽

Dajun Sun ◽

Knut Wagner ◽

Melanie Schneider ◽

Holger Bauer ◽

...

Keyword(s):

Oral Absorption ◽

Pharmacokinetic Modeling ◽

Water Soluble ◽

Physiologically Based Pharmacokinetic Modeling ◽

Poorly Water Soluble Drugs ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Water Soluble Drugs ◽

Poorly Water Soluble

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The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives

The Journal of Clinical Pharmacology ◽

10.1002/jcph.740 ◽

2016 ◽

Vol 56 ◽

pp. S122-S131 ◽

Cited By ~ 33

Author(s):

Yuzhuo Pan ◽

Vicky Hsu ◽

Manuela Grimstein ◽

Lei Zhang ◽

Vikram Arya ◽

...

Keyword(s):

Drug Transporters ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2011.320 ◽

2012 ◽

Vol 91 (3) ◽

pp. 542-549 ◽

Cited By ~ 98

Author(s):

S-M Huang ◽

M Rowland

Keyword(s):

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Regulatory Review ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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Biological Monitoring: The Role of Toxicokinetics and Physiologically Based Pharmacokinetic Modeling

AIHAJ ◽

10.1080/00028899908984442 ◽

1999 ◽

Vol 60 (2) ◽

pp. 237-242 ◽

Cited By ~ 14

Author(s):

Howard Mason ◽

Kerr Wilson

Keyword(s):

Biological Monitoring ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 2: Model for the Drug-combination Nanoparticles

Journal of Pharmaceutical Sciences ◽

10.1016/j.xphs.2021.10.009 ◽

2021 ◽

Author(s):

Simone Perazzolo ◽

Danny D. Shen ◽

Rodney J.Y. Ho

Keyword(s):

Drug Combination ◽

Lymphatic System ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Hiv Drugs

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Physiologically Based Pharmacokinetic Modeling of 3 HIV Drugs in Combination and the Role of Lymphatic System after Subcutaneous Dosing. Part 1: Model for the Free-drug Mixture

Journal of Pharmaceutical Sciences ◽

10.1016/j.xphs.2021.10.007 ◽

2021 ◽

Author(s):

Simone Perazzolo ◽

Laura M. Shireman ◽

Danny D. Shen ◽

Rodney J.Y. Ho

Keyword(s):

Lymphatic System ◽

Pharmacokinetic Modeling ◽

Free Drug ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Drug Mixture ◽

Physiologically Based ◽

Hiv Drugs

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Biological Monitoring: The Role of Toxicokinetics and Physiologically Based Pharmacokinetic Modeling

AIHAJ ◽

10.1202/0002-8894(1999)060<0237:bmtrot>2.0.co;2 ◽

1999 ◽

Vol 60 (2) ◽

pp. 237-242

Author(s):

Howard Mason ◽

Kerr Wilson

Keyword(s):

Biological Monitoring ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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Pharmacokinetic Characterization to Enable Medicine Use in Pregnancy, the Potential Role of Physiologically‐Based Pharmacokinetic Modeling: A Regulatory Perspective

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12551 ◽

2020 ◽

Vol 9 (10) ◽

pp. 547-549

Author(s):

Susan Cole ◽

Paola Coppola ◽

Essam Kerwash ◽

Janet Nooney ◽

Siu Ping Lam

Keyword(s):

Potential Role ◽

Pharmacokinetic Modeling ◽

Medicine Use ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Regulatory Perspective ◽

Physiologically Based ◽

In Pregnancy

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Role of Physiologically Based Pharmacokinetic Modeling and Simulation in Enabling Model‐Informed Development of Drugs and Biotherapeutics

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1770 ◽

2020 ◽

Vol 60 (S1) ◽

Author(s):

Vikram Arya ◽

Karthik Venkatakrishnan

Keyword(s):

Modeling And Simulation ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based ◽

Pharmacokinetic Modeling And Simulation

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Application of physiologically-based pharmacokinetic modeling to explore the role of kidney transporters in renal reabsorption of perfluorooctanoic acid in the rat

Toxicology and Applied Pharmacology ◽

10.1016/j.taap.2015.10.017 ◽

2015 ◽

Vol 289 (3) ◽

pp. 428-441 ◽

Cited By ~ 27

Author(s):

Rachel Rogers Worley ◽

Jeffrey Fisher

Keyword(s):

Perfluorooctanoic Acid ◽

Pharmacokinetic Modeling ◽

Physiologically Based Pharmacokinetic Modeling ◽

Renal Reabsorption ◽

Physiologically Based Pharmacokinetic ◽

Physiologically Based

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