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The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

European journal of pharmaceutical sciences, 2019-06, Vol.134, p.31-59

2019

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Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

Nature reviews. Drug discovery, 2013-02, Vol.12 (2), p.103-115

2013

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Drug switching in the Netherlands: a cohort study of 20 active substances

BMC health services research, 2020-07, Vol.20 (1), p.650-10, Article 650

2020

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Reported hepatotoxicity and hepatotoxicity guidance in the product information of protein kinase inhibitors in oncology registered at the European Medicines Agency

Pharmacology research & perspectives, 2023-04, Vol.11 (2), p.e01067-n/a

2023

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Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

Frontiers in medicine, 2022-05, Vol.9, p.893028-893028

2022

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Comment on “Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?”

Clinical pharmacokinetics, 2020-02, Vol.59 (2), p.281-282

2020

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Interchangeability of Generics—Experiences and Outlook Toward Pharmacokinetics Variability and Generic‐Generic Substitution

Clinical pharmacology and therapeutics, 2019-02, Vol.105 (2), p.292-294

2019

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Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands

Clinical and translational science, 2020-05, Vol.13 (3), p.599-607

2020

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Circumvention of Breast Cancer Resistance Protein (BCRP)-mediated Resistance to Camptothecins in Vitro Using Non-Substrate Drugs or the BCRP Inhibitor GF120918

Clinical cancer research, 2001-04, Vol.7 (4), p.935-941

2001

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Expression of the Breast Cancer Resistance Protein in Breast Cancer

Clinical cancer research, 2002-04, Vol.8 (4), p.1068-1074

2002

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Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017

Clinical pharmacology and therapeutics, 2020-08, Vol.108 (2), p.338-349

2020

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A comparison of the intrasubject variation in drug exposure between generic and brand‐name drugs: a retrospective analysis of replicate design trials

British journal of clinical pharmacology, 2016-04, Vol.81 (4), p.667-678

2016

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Pharmacokinetics and Generic Drug Switching: A Regulator’s View

Clinical pharmacokinetics, 2020-09, Vol.59 (9), p.1065-1069

2020

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Phase I and pharmacokinetic study of SPI-77, a liposomal encapsulated dosage form of cisplatin

Cancer chemotherapy and pharmacology, 2002-03, Vol.49 (3), p.201-210

2002

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Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines

European journal of clinical pharmacology, 2015-08, Vol.71 (8), p.979-990

2015

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Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of cyclosporin, tacrolimus and mycophenolate mofetil

GaBI Journal, 2013-06, Vol.2 (2), p.86-90

Maliepaard, Marc

2013

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Interchangeability of generic drugs for subpopulations: Bioequivalence simulation from a nonparametric PK model of gabapentin generic drugs

British journal of clinical pharmacology, 2024-07, Vol.90 (7), p.1576-1585

2024

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Dose selection of novel anticancer drugs: exposing the gap between selected and required doses

The lancet oncology, 2024-08, Vol.25 (8), p.e340-e351

2024

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Impact of the new European Union In Vitro Diagnostics Regulation on the practice of hospital diagnostic laboratories

Expert review of molecular diagnostics, 2022-05, Vol.22 (5), p.583-590

2022

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Subcellular localization and distribution of the Breast Cancer Resistance Protein transporter in normal human tissues

Cancer research (Chicago, Ill.), 2001-04, Vol.61 (8), p.3458-3464

2001

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Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs

Clinical pharmacology and therapeutics, 2018-11, Vol.104 (5), p.966-973

2018

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Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?

Pharmaceutical medicine, 2019-10, Vol.33 (5), p.407-416

2019

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Role of Breast Cancer Resistance Protein in the Bioavailability and Fetal Penetration of Topotecan

JNCI : Journal of the National Cancer Institute, 2000-10, Vol.92 (20), p.1651-1656

2000

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Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

GaBI Journal, 2021-09, Vol.10 (3), p.1-122

2021

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Randomized Phase I Clinical and Pharmacologic Study of Weekly versus Twice-Weekly Dose-intensive Cisplatin and Gemcitabine in Patients with Advanced Non-Small Cell Lung Cancer

Clinical cancer research, 2003-09, Vol.9 (10), p.3526-3533

2003

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The mechanisms of pharmacokinetic food-drug interactions – A perspective from the UNGAP group

Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

Drug switching in the Netherlands: a cohort study of 20 active substances

Reported hepatotoxicity and hepatotoxicity guidance in the product information of protein kinase inhibitors in oncology registered at the European Medicines Agency

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

Comment on “Levothyrox® New and Old Formulations: Are they Switchable for Millions of Patients?”

Interchangeability of Generics—Experiences and Outlook Toward Pharmacokinetics Variability and Generic‐Generic Substitution

Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands

Circumvention of Breast Cancer Resistance Protein (BCRP)-mediated Resistance to Camptothecins in Vitro Using Non-Substrate Drugs or the BCRP Inhibitor GF120918

Expression of the Breast Cancer Resistance Protein in Breast Cancer

Pharmacogenetic‐Pharmacokinetic Interactions in Drug Marketing Authorization Applications via the European Medicines Agency Between 2014 and 2017

A comparison of the intrasubject variation in drug exposure between generic and brand‐name drugs: a retrospective analysis of replicate design trials

Pharmacokinetics and Generic Drug Switching: A Regulator’s View

Phase I and pharmacokinetic study of SPI-77, a liposomal encapsulated dosage form of cisplatin

Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines

Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of cyclosporin, tacrolimus and mycophenolate mofetil

Interchangeability of generic drugs for subpopulations: Bioequivalence simulation from a nonparametric PK model of gabapentin generic drugs

Dose selection of novel anticancer drugs: exposing the gap between selected and required doses

Impact of the new European Union In Vitro Diagnostics Regulation on the practice of hospital diagnostic laboratories

Subcellular localization and distribution of the Breast Cancer Resistance Protein transporter in normal human tissues

Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs

Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?

Role of Breast Cancer Resistance Protein in the Bioavailability and Fetal Penetration of Topotecan

Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

Randomized Phase I Clinical and Pharmacologic Study of Weekly versus Twice-Weekly Dose-intensive Cisplatin and Gemcitabine in Patients with Advanced Non-Small Cell Lung Cancer

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