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The Use of External Controls in FDA Regulatory Decision Making

Therapeutic innovation & regulatory science, 2021-09, Vol.55 (5), p.1019-1035

2021

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Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach

Therapeutic innovation & regulatory science, 2021-07, Vol.55 (4), p.799-806

2021

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Paediatric extrapolation: A necessary paradigm shift

British journal of clinical pharmacology, 2019-04, Vol.85 (4), p.675-679

2019

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Paediatric investigation plans for pain: painfully slow

European journal of clinical pharmacology, 2010-11, Vol.66 (11), p.1091-1097

2010

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The Rare Disease Moonshot: Paradigms Shift, Translational Medicine, and Regulatory Science for the World's Rarest Conditions

Clinical pharmacology and therapeutics, 2024-08

2024

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Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?

Clinical pharmacology and therapeutics, 2022-04, Vol.111 (4), p.799-806

2022

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Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics

British journal of clinical pharmacology, 2019-04, Vol.85 (4), p.659-668

2019

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New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017

Journal of the American Heart Association, 2019-05, Vol.8 (10), p.e011306

2019

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Pediatric Extrapolation of Adult Efficacy to Children Is Critical for Efficient and Successful Drug Development

Gastroenterology (New York, N.Y. 1943), 2022-07, Vol.163 (1), p.77-83

2022

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Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop

Clinical pharmacology and therapeutics, 2020-07, Vol.108 (1), p.29-39

2020

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Un nouveau site magdalénien sur la commune de Corbeil-Essonnes (Essonne)

Nouvelles de l'archéologie, 2012-10, Vol.129, p.47-53

2012

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Commentary on the EMA R eflection P aper on the use of extrapolation in the development of medicines for paediatrics

British journal of clinical pharmacology, 2019-04, Vol.85 (4), p.659-668

2019

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Correction: Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Pediatric research, 2023-06, Vol.94 (6), p.2121-2121

2023

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Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Pediatric research, 2022-04, Vol.91 (5), p.1069-1077

2022

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Un nouveau site magdalénien sur la commune de Corbeil-Essonnes (Essonne)

Nouvelles de l'archéologie, 2012-10 (129), p.47-53

2012

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Typing of Scedosporium apiospermum by multilocus enzyme electrophoresis and random amplification of polymorphic DNA

Journal of medical microbiology, 2001-10, Vol.50 (10), p.925-932

2001

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Les origines de la Préhistoire

Nouvelles de l'archéologie, 2012

2012

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Scaling Dose-Exposure-Response from Adults to Children

Fundamentals of Pediatric Drug Dosing, 2016, p.93-107

2016

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Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial

Haematologica (Roma), 2019-01, Vol.104 (1), p.113-119

2019

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The contribution of platelet glycoprotein receptors to inflammatory bleeding prevention is stimulus and organ dependent

Haematologica (Roma), 2018-06, Vol.103 (6), p.e256-e258

2018

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Yarrowia lipolytica causes sporadic cases and local outbreaks of infections and colonisation

Mycoses, 2020-07, Vol.63 (7), p.737-745

2020

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A stem cell population at the anorectal junction maintains homeostasis and participates in tissue regeneration

Nature communications, 2021-05, Vol.12 (1), p.2761-2761, Article 2761

2021

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Alcoholic fermentation drives the selection of Oenococcus oeni strains in wine but not in cider

International journal of food microbiology, 2023-09, Vol.400, p.110276-110276, Article 110276

2023

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Ancient DNA reveals the origins, colonization histories, and evolutionary pathways of two recently extinct species of giant scops owl from Mauritius and Rodrigues Islands (Mascarene Islands, south-western Indian Ocean)

Journal of biogeography, 2018-12, Vol.45 (12), p.2678-2689

2018

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The Use of External Controls in FDA Regulatory Decision Making

Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach

Paediatric extrapolation: A necessary paradigm shift

Paediatric investigation plans for pain: painfully slow

The Rare Disease Moonshot: Paradigms Shift, Translational Medicine, and Regulatory Science for the World's Rarest Conditions

Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?

Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics

New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017

Pediatric Extrapolation of Adult Efficacy to Children Is Critical for Efficient and Successful Drug Development

Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop

Un nouveau site magdalénien sur la commune de Corbeil-Essonnes (Essonne)

Commentary on the EMA R eflection P aper on the use of extrapolation in the development of medicines for paediatrics

Correction: Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Un nouveau site magdalénien sur la commune de Corbeil-Essonnes (Essonne)

Typing of Scedosporium apiospermum by multilocus enzyme electrophoresis and random amplification of polymorphic DNA

Les origines de la Préhistoire

Scaling Dose-Exposure-Response from Adults to Children

Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial

The contribution of platelet glycoprotein receptors to inflammatory bleeding prevention is stimulus and organ dependent

Yarrowia lipolytica causes sporadic cases and local outbreaks of infections and colonisation

Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study

A stem cell population at the anorectal junction maintains homeostasis and participates in tissue regeneration

Alcoholic fermentation drives the selection of Oenococcus oeni strains in wine but not in cider

Ancient DNA reveals the origins, colonization histories, and evolutionary pathways of two recently extinct species of giant scops owl from Mauritius and Rodrigues Islands (Mascarene Islands, south-western Indian Ocean)

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