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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.556-559

2023

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Population pharmacokinetic–pharmacodynamic analysis for sugammadex‐mediated reversal of rocuronium‐induced neuromuscular blockade

British journal of clinical pharmacology, 2011-09, Vol.72 (3), p.415-433

2011

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Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive

Contraception (Stoneham), 2005-09, Vol.72 (3), p.168-174

2005

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An Evidence-Based Rationale for Dose De-escalation of Subcutaneous Atezolizumab

Targeted oncology, 2024-09, Vol.19 (5), p.779-787

2024

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Flucloxacillin and Diclofenac do not Cause Recurrence of Neuromuscular Blockade after Reversal with Sugammadex

Clinical drug investigation, 2012-03, Vol.32 (3), p.203-212

2012

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Safety, Tolerability and Pharmacokinetics of Sugammadex Using Single High Doses (Up to 96 mg/kg) in Healthy Adult Subjects: A Randomized, Double-Blind, Crossover, Placebo-Controlled, Single-Centre Study

Clinical drug investigation, 2010, Vol.30 (12), p.1

2010

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Pharmacokinetics of sugammadex 16 mg/kg in healthy Chinese volunteers

International journal of clinical pharmacology and therapeutics, 2015-06, Vol.53 (6), p.456-461

2015

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Safety, Tolerability and Pharmacokinetics of Sugammadex Using Single High Doses (Up to 96 mg/kg) in Healthy Adult Subjects: A Randomized, Double-Blind, Crossover, Placebo-Controlled, Single-Centre Study

Clinical drug investigation, 2010-12, Vol.30 (12), p.867-874

2010

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Absence of pharmacokinetic interactions of the combined contraceptive vaginal ring Nuvaring® with oral amoxicillin or doxycycline in two randomised trials

Clinical pharmacokinetics, 2005-01, Vol.44 (4), p.429-438

2005

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Effect of Sugammadex on QT/QTc Interval Prolongation when Combined with QTc-Prolonging Sevoflurane or Propofol Anaesthesia

Clinical drug investigation, 2013-08, Vol.33 (8), p.545-551

2013

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Bioequivalence and X-Ray Visibility of a Radiopaque Etonogestrel Implant versus a Non-Radiopaque Implant: A 3-Year, Randomized, Double-Blind Study

Clinical drug investigation, 2012-06, Vol.32 (6), p.413-422

2012

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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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Assessment of the Potential for Displacement Interactions with Sugammadex: A Pharmacokinetic-Pharmacodynamic Modelling Approach

Clinical drug investigation, 2011-02, Vol.31 (2), p.101-111

2011

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Assessment of the Potential for Displacement Interactions with Sugammadex: A Pharmacokinetic-Pharmacodynamic Modelling Approach

Clinical drug investigation, 2011, Vol.31 (2), p.1

2011

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Development of In Vitro–In Vivo Correlation for Extended‐Release Niacin After Administration of Hypromellose‐Based Matrix Formulations to Healthy Volunteers

Journal of pharmaceutical sciences, 2014-11, Vol.103 (11), p.3713-3723

2014

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Commentary on the MID3 Good Practices Paper

CPT: pharmacometrics and systems pharmacology, 2017-07, Vol.6 (7), p.416-417

2017

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Bioequivalence and X-Ray Visibility of a Radiopaque Etonogestrel Implant versus a Non-Radiopaque Implant

Clinical drug investigation, 2012-06, Vol.32 (6), p.413

2012

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Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices

Clinical laboratory (Heidelberg), 2003, Vol.49 (9-10), p.451

2003

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Temperate Versus Arctic: Unraveling the Effects of Temperature on Oil Toxicity in Gammarids

Environmental toxicology and chemistry, 2024-07, Vol.43 (7), p.1627-1637

2024

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The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions

PloS one, 2023-07, Vol.18 (7), p.e0288912-e0288912

2023

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Oral bioaccessibility of toxic and essential elements in raw and cooked commercial seafood species available in European markets

Food chemistry, 2018-11, Vol.267, p.15-27

2018

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Omission of doxorubicin from the treatment of stage II–III, intermediate-risk Wilms' tumour (SIOP WT 2001): an open-label, non-inferiority, randomised controlled trial

The Lancet (British edition), 2015-09, Vol.386 (9999), p.1156-1164

2015

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Nephrotic syndrome in a dish: recent developments in modeling in vitro

Pediatric nephrology (Berlin, West), 2020-08, Vol.35 (8), p.1363-1372

2020

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A Functional Genetic Screen Identifies the Phosphoinositide 3-kinase Pathway as a Determinant of Resistance to Fibroblast Growth Factor Receptor Inhibitors in FGFR Mutant Urothelial Cell Carcinoma

European urology, 2017-06, Vol.71 (6), p.858-862

2017

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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

Population pharmacokinetic–pharmacodynamic analysis for sugammadex‐mediated reversal of rocuronium‐induced neuromuscular blockade

Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive

An Evidence-Based Rationale for Dose De-escalation of Subcutaneous Atezolizumab

Flucloxacillin and Diclofenac do not Cause Recurrence of Neuromuscular Blockade after Reversal with Sugammadex

Safety, Tolerability and Pharmacokinetics of Sugammadex Using Single High Doses (Up to 96 mg/kg) in Healthy Adult Subjects: A Randomized, Double-Blind, Crossover, Placebo-Controlled, Single-Centre Study

Pharmacokinetics of sugammadex 16 mg/kg in healthy Chinese volunteers

Safety, Tolerability and Pharmacokinetics of Sugammadex Using Single High Doses (Up to 96 mg/kg) in Healthy Adult Subjects: A Randomized, Double-Blind, Crossover, Placebo-Controlled, Single-Centre Study

Absence of pharmacokinetic interactions of the combined contraceptive vaginal ring Nuvaring® with oral amoxicillin or doxycycline in two randomised trials

Effect of Sugammadex on QT/QTc Interval Prolongation when Combined with QTc-Prolonging Sevoflurane or Propofol Anaesthesia

Bioequivalence and X-Ray Visibility of a Radiopaque Etonogestrel Implant versus a Non-Radiopaque Implant: A 3-Year, Randomized, Double-Blind Study

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

Assessment of the Potential for Displacement Interactions with Sugammadex: A Pharmacokinetic-Pharmacodynamic Modelling Approach

Assessment of the Potential for Displacement Interactions with Sugammadex: A Pharmacokinetic-Pharmacodynamic Modelling Approach

Development of In Vitro–In Vivo Correlation for Extended‐Release Niacin After Administration of Hypromellose‐Based Matrix Formulations to Healthy Volunteers

Commentary on the MID3 Good Practices Paper

Bioequivalence and X-Ray Visibility of a Radiopaque Etonogestrel Implant versus a Non-Radiopaque Implant

Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices

Temperate Versus Arctic: Unraveling the Effects of Temperature on Oil Toxicity in Gammarids

The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions

Oral bioaccessibility of toxic and essential elements in raw and cooked commercial seafood species available in European markets

Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial

Omission of doxorubicin from the treatment of stage II–III, intermediate-risk Wilms' tumour (SIOP WT 2001): an open-label, non-inferiority, randomised controlled trial

Nephrotic syndrome in a dish: recent developments in modeling in vitro

A Functional Genetic Screen Identifies the Phosphoinositide 3-kinase Pathway as a Determinant of Resistance to Fibroblast Growth Factor Receptor Inhibitors in FGFR Mutant Urothelial Cell Carcinoma

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