Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen

Dissolution Testing ◽

Clinically Relevant Specifications

Biorelevant Dissolution ◽

Physiologically Based ◽

Predictive Performance of Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling of Renally Cleared Drugs in Children

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12101 ◽

2016 ◽

Vol 5 (9) ◽

pp. 475-483 ◽

Cited By ~ 25

Author(s):

W Zhou ◽

TN Johnson ◽

H Xu ◽

SYA Cheung ◽

KH Bui ◽

...

Keyword(s):

Predictive Performance ◽

Bottom-up Meets Top-down: Complementary Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling for Regulatory Approval of a Dosing Algorithm of Valganciclovir in Very Young Children

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.449 ◽

2016 ◽

Vol 100 (6) ◽

pp. 761-769 ◽

Cited By ~ 14

Author(s):

K Jorga ◽

C Chavanne ◽

N Frey ◽

T Lave ◽

V Lukacova ◽

...

Keyword(s):

Young Children ◽

Regulatory Approval ◽

Top Down ◽

Very Young Children ◽

Dosing Algorithm ◽

Comparison Between Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling to Select Paediatric Doses of Gepotidacin in Plague

British Journal of Clinical Pharmacology ◽

10.1111/bcp.14996 ◽

2021 ◽

Author(s):

Dung Nguyen ◽

Jafar Sadik Shaik ◽

Guoying Tai ◽

Courtney Tiffany ◽

Caroline Perry ◽

...

Keyword(s):

Investigating the Impact of Drug Crystallinity in Amorphous Tacrolimus Capsules on Pharmacokinetics and Bioequivalence Using Discriminatory In Vitro Dissolution Testing and Physiologically Based Pharmacokinetic Modeling and Simulation

Journal of Pharmaceutical Sciences ◽

10.1016/j.xphs.2017.12.024 ◽

2018 ◽

Vol 107 (5) ◽

pp. 1330-1341 ◽

Cited By ~ 22

Author(s):

Hitesh S. Purohit ◽

Niraj S. Trasi ◽

Dajun D. Sun ◽

Edwin C.Y. Chow ◽

Hong Wen ◽

...

Keyword(s):

Modeling And Simulation ◽

In Vitro Dissolution ◽

Dissolution Testing ◽

Physiologically Based Pharmacokinetic Modeling ◽

Pharmacokinetic Modeling And Simulation

Physiologically Based ◽

The Impact ◽

Physiologically Based Population Pharmacokinetic Modeling Approach for Ciprofloxacin in Bone of Patients Undergoing Orthopedic Surgery

ACS Pharmacology & Translational Science ◽

10.1021/acsptsci.0c00045 ◽

2020 ◽

Vol 3 (3) ◽

pp. 444-454 ◽

Cited By ~ 1

Author(s):

Cornelia B. Landersdorfer ◽

Martina Kinzig ◽

Rainer Höhl ◽

Peter Kempf ◽

Roger L. Nation ◽

...

Keyword(s):

Orthopedic Surgery ◽

Modeling Approach ◽

Application of Physiologically‐Based and Population Pharmacokinetic Modeling for Dose Finding and Confirmation During the Pediatric Development of Moxifloxacin

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12446 ◽

2019 ◽

Vol 8 (9) ◽

pp. 654-663 ◽

Cited By ~ 2

Author(s):

Stefan Willmann ◽

Matthias Frei ◽

Gabriele Sutter ◽

Katrin Coboeken ◽

Thomas Wendl ◽

...

Keyword(s):

Dose Finding ◽

Prediction of food effects on the absorption of celecoxib based on biorelevant dissolution testing coupled with physiologically based pharmacokinetic modeling

European Journal of Pharmaceutics and Biopharmaceutics ◽

10.1016/j.ejpb.2009.05.009 ◽

2009 ◽

Vol 73 (1) ◽

pp. 107-114 ◽

Cited By ~ 100

Author(s):

Yasushi Shono ◽

Ekarat Jantratid ◽

Niels Janssen ◽

Filippos Kesisoglou ◽

Yun Mao ◽

...

Keyword(s):

Dissolution Testing ◽

Physiologically Based Pharmacokinetic Modeling ◽

Food Effects ◽

Biorelevant Dissolution ◽

Population Pharmacokinetic Modeling of Etoposide Free Concentrations in Solid Tumor

Pharmaceutical Research ◽

10.1007/s11095-016-1906-4 ◽

2016 ◽

Vol 33 (7) ◽

pp. 1657-1670 ◽

Cited By ~ 6

Author(s):

Maiara Cássia Pigatto ◽

Bibiana Verlindo de Araujo ◽

Bruna Gaelzer Silva Torres ◽

Stephan Schmidt ◽

Paolo Magni ◽

...

Keyword(s):

Solid Tumor ◽

Population Pharmacokinetic Modeling

Population pharmacokinetic modeling of molibresib and its active metabolites in patients with solid tumors: a semi‐mechanistic autoinduction model

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12639 ◽

2021 ◽

Author(s):

Anu Shilpa Krishnatry ◽

Alexander Voelkner ◽

Arindam Dhar ◽

Marita Prohn ◽

Geraldine Ferron‐Brady

Keyword(s):

Solid Tumors ◽

Population Pharmacokinetic Modeling

Active Metabolites ◽

Current Ceftriaxone Dose Recommendations are Adequate for Most Critically Ill Children: Results of a Population Pharmacokinetic Modeling and Simulation Study

Clinical Pharmacokinetics ◽

10.1007/s40262-021-01035-9 ◽

2021 ◽

Author(s):

Stan J. F. Hartman ◽

Parth J. Upadhyay ◽

Nienke N. Hagedoorn ◽

Ron A. A. Mathôt ◽

Henriëtte A. Moll ◽

...

Keyword(s):

Modeling And Simulation ◽

Critically Ill ◽

Simulation Study ◽

Critically Ill Children ◽

Pharmacokinetic Modeling And Simulation

Dose Recommendations ◽