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The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: Conclusions and recommendations

Journal of pharmacological and toxicological methods, 2010-11, Vol.62 (3), p.236-242

2010

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Revision of ICH S8 Needed?

Frontiers in toxicology, 2022-04, Vol.4, p.866737-866737

Van Der Laan, Jan Willem

2022

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Towards a mechanism-based approach for the prediction of nongenotoxic carcinogenic potential of agrochemicals

Critical reviews in toxicology, 2020-10, Vol.50 (9), p.725-739

2020

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An integrative test strategy for cancer hazard identification

Critical reviews in toxicology, 2016-08, Vol.46 (7), p.615-639

2016

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A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals

Regulatory toxicology and pharmacology, 2020-12, Vol.118, p.104789, Article 104789

2020

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Insulin-like growth factor 1 receptor activation promotes mammary gland tumor development by increasing glycolysis and promoting biomass production

Breast cancer research : BCR, 2017-02, Vol.19 (1), p.14-14, Article 14

2017

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Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products

Journal of pharmacological and toxicological methods, 2010-11, Vol.62 (3), p.184-195

2010

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Nonclinical regulatory immunotoxicity testing of nanomedicinal products: Proposed strategy and possible pitfalls

Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology, 2020-09, Vol.12 (5), p.e1633-n/a

2020

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Treatment with insulin (analogues) and breast cancer risk in diabetics; a systematic review and meta-analysis of in vitro, animal and human evidence

Breast cancer research : BCR, 2015-08, Vol.17 (1), p.100, Article 100

2015

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Alternative signaling network activation through different insulin receptor family members caused by pro-mitogenic antidiabetic insulin analogues in human mammary epithelial cells

Breast cancer research : BCR, 2015-07, Vol.17 (1), p.97, Article 97

2015

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ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup

Frontiers in toxicology, 2024-04, Vol.6, p.1353783-1353783

2024

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Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals

Advances in experimental medicine and biology, 2016, Vol.856, p.33-64

2016

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Prediction of carcinogenic potential of chemicals using repeated-dose (13-week) toxicity data

Regulatory toxicology and pharmacology, 2016-11, Vol.81, p.242-249

2016

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New adjuvanted vaccines in pregnancy: what is known about their safety?

Expert review of vaccines, 2010-12, Vol.9 (12), p.1411-1422

2010

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In vitro cytokine release assays for predicting cytokine release syndrome: The current state-of-the-science. Report of a European Medicines Agency Workshop

Cytokine, 2010-08, Vol.51 (2), p.213-215

2010

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Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018

Therapeutic innovation & regulatory science, 2020-03, Vol.54 (2), p.462-467

2020

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Prediction of the Carcinogenic Potential of Human Pharmaceuticals Using Repeated Dose Toxicity Data and Their Pharmacological Properties

Frontiers in medicine, 2016-10, Vol.3, p.45-45

2016

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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

British journal of clinical pharmacology, 2023-08, Vol.89 (8), p.2341-2348

2023

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Testing strategies for embryo-fetal toxicity of human pharmaceuticals. Animal models vs. in vitro approaches

Regulatory toxicology and pharmacology, 2012-06, Vol.63 (1), p.115-123

2012

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Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report

Drug information journal, 2000, Vol.34 (3), p.821-828

2000

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Mechanisms of Nongenotoxic Carcinogenesis and Assessment of the Human Hazard

Regulatory toxicology and pharmacology, 2000-10, Vol.32 (2), p.135-143

2000

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WHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24–25 January 2005

Vaccine, 2006-05, Vol.24 (20), p.4271-4278

2006

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Response to: “The Role of Quantitative Systems Pharmacology in the Design of First‐in‐Human Trials”

Clinical pharmacology and therapeutics, 2018-11, Vol.104 (5), p.798-798

2018

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Mining scientific advice reports on cell‐based products: Insight into the nonclinical development program

British journal of clinical pharmacology, 2021-06, Vol.87 (6), p.2465-2474

2021

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The RETHINK project on minipigs in the toxicity testing of new medicines and chemicals: Conclusions and recommendations

Revision of ICH S8 Needed?

Towards a mechanism-based approach for the prediction of nongenotoxic carcinogenic potential of agrochemicals

An integrative test strategy for cancer hazard identification

A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals

Insulin-like growth factor 1 receptor activation promotes mammary gland tumor development by increasing glycolysis and promoting biomass production

Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products

Nonclinical regulatory immunotoxicity testing of nanomedicinal products: Proposed strategy and possible pitfalls

Treatment with insulin (analogues) and breast cancer risk in diabetics; a systematic review and meta-analysis of in vitro, animal and human evidence

Alternative signaling network activation through different insulin receptor family members caused by pro-mitogenic antidiabetic insulin analogues in human mammary epithelial cells

ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals

Prediction of carcinogenic potential of chemicals using repeated-dose (13-week) toxicity data

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects

New adjuvanted vaccines in pregnancy: what is known about their safety?

In vitro cytokine release assays for predicting cytokine release syndrome: The current state-of-the-science. Report of a European Medicines Agency Workshop

Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018

Prediction of the Carcinogenic Potential of Human Pharmaceuticals Using Repeated Dose Toxicity Data and Their Pharmacological Properties

EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

Testing strategies for embryo-fetal toxicity of human pharmaceuticals. Animal models vs. in vitro approaches

Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report

Mechanisms of Nongenotoxic Carcinogenesis and Assessment of the Human Hazard

WHO informal consultation on scientific basis for regulatory evaluation of candidate human vaccines from plants, Geneva, Switzerland, 24–25 January 2005

Response to: “The Role of Quantitative Systems Pharmacology in the Design of First‐in‐Human Trials”

Mining scientific advice reports on cell‐based products: Insight into the nonclinical development program

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