Articles in Journal
2024
Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective
Giannuzzi V, Bertolani A, Torretta S, Reggiardo G, Toich E, Bonifazi D and Ceci A
Front. Med. 11:1369547. doi: 10.3389/fmed.2024.1369547
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2022
European research networks to facilitate drug research in children
Br J Clin Pharmacol 2022 Oct;88(10):4258-4266. doi: 10.1111/bcp.14545. Epub 2020 Sep 20.
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Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies
Lederer C.W, Koniali L, Buerki-Thurnherr T, Papasavva P.L, La Grutta S, Licari A, Staud F, Bonifazi D, Kleanthous M.
Pharmaceutics 2022, 14, 793. doi.org/10.3390/
2021
Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities
P. Dimitri, V. Pignataro, M. Lupo, D. Bonifazi , M. Henke , U. M. Musazzi, F. Ernst, P. Minghetti, D. F. Redaelli, S. G. Antimisiaris, G. Migliaccio, F. Bonifazi, L. Marciani, A. J. Courtenay, N. Denora, A. Lopedota
Pharmaceutics 2021, 13(12), 2178; https://doi.org/10.3390/pharmaceutics13122178
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The GluN2B-Selective Antagonist Ro 25-6981 Is Effective
P. Mareš, L. Kozlová , A. Mikulecká, H. Kubová
Pharmaceutics 2021, 13, 1482; https://doi.org/10.3390/pharmaceutics13091482
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Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure)
E. Alessandrini, F. Brako, M. Scarpa, M. Lupo , D. Bonifazi, V. Pignataro, M. Cavallo, O. Cullufe, C. Enache, B. Nafria, J. Claverol, L. De Taeye, E. Vermeulen, J. Preston, C. Tuleu
Pharmaceutics 2021, 13, 730; https://doi.org/10.3390/pharmaceutics13050730
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Detection of Breathing Movements of Preterm Neonates by Recording Their Abdominal Movements with a Time-of-Flight Camera
F. C. Wiegandt, D. Biegger , J. F. Fast, G. Matusiak, J. Mazela, T. Ortmaier, T. Doll, A. Dietzel, B. Bohnhorst, G. Pohlmann
Pharmaceutics 2021, 13, 721; https://doi.org/10.3390/pharmaceutics13050721
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Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review
B. Aurich, E. Jacqz-Aigrain
Pharmaceutics 2021, 13, 695; https://doi.org/10.3390/pharmaceutics13050695
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Breath-Triggered Drug Release System for Preterm Neonates
F. C. Wiegandt, U. P. Froriep, F. Müller, T. Doll, A. Dietzel, G. Pohlmann
Pharmaceutics 2021, 13, 657; https://doi.org/10.3390/pharmaceutics13050657
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Human Microbiome in Children, at the Crossroad of Social Determinants of Health and Personalized Medicine
Talía Sainz, Valeria Pignataro, Donato Bonifazi, Simona Ravera, María José Mellado, Antonio Pérez-Martínez , Adela Escudero, Adriana Ceci and Cristina Calvo
Children 2021, 8, 1191; https://doi.org/10.3390/children8121191
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The Neonatal and Juvenile Pig in Pediatric Drug Discovery and Development
M. Ayuso, L. Buyssens, M. Stroe, A. Valenzuela, K. Allegaert, A. Smits, P. Annaert, A. Mulder, S. Carpentier, C. Van Ginneken, S. Van Cruchten
Pharmaceutics 2021, 13/3; doi: 10.3390/pharmaceutics13030415
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Patient-Derived Induced Pluripotent Stem Cells (iPSCs) and Cerebral Organoids for Drug Screening and Development in Autism Spectrum Disorder: Opportunities and Challenges
C. Villa, R. Combi, D. Conconi, M. Lavitrano
Pharmaceutics 2021, 13/2; doi: 10.3390/pharmaceutics13020280
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2020
Involve Children and Parents in Clinical Studies
Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance
A. Altavilla, V. Giannuzzi, M. Lupo, D. Bonifazi, A. Ceci
European Journal of Health Law 2020, May 18; doi: 10.1163/15718093-bja10010
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Pediatric Biobanking: Kids Are Not Just Little Adults
D. R. Catchpoole, D. Carpentieri, S. Vercauteren, L. Wadhwa, W. Schleif, L. Zhou, J. Zhou, R. M. Labib, E. Smits, E. H. Conradie
Biopreservation and Biobanking 18/4, 2020, August; doi: 10.1089/bio.2020.29071.djc
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2018
Drug evaluation in children 10years after the European pediatric regulation current challenges and perspectives
Chapter in book
Challenges and New Frontiers in the Paediatric Drug Discovery and Development
A. Intini, D. Bonifazi, G. Migliaccio
Drug Discovery and Development – New Advances, 2019; 10.5772/intechopen.85635
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Preface: overview of pediatric drug development and pharmacovigilance
Elke Gasthuys, Lien Dossche, Karel Allegaert, Mark A Turner
Essentials of Translational Pediatric Drug Development – From Past Needs to Future Opportunities, 2024; Paperback ISBN: eBook ISBN:
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The needs, challenges and opportunities from the academic researchers’ perspective
Elke Gasthuys, Karel Allegaert, Eva Degraeuwe, Hidefumi Nakamura, Johan Vande Walle, Gregory Kearns
Essentials of Translational Pediatric Drug Development – From Past Needs to Future Opportunities, 2024; Paperback ISBN: eBook ISBN:
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Application of preclinical juvenile animal models
Eline Hermans, Jaan Toelen, Domenico Ventrella, Luc De Schaepdrijver, Katie Turner, Siska Croubels, Mathias Devreese
Essentials of Translational Pediatric Drug Development – From Past Needs to Future Opportunities, 2024; Paperback ISBN: eBook ISBN:
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Performing clinical drug trials in acute and critically ill neonates and children
Pieter A De Cock, Anne Smits, Mehdi Oualha, Gideon Stitt, Tuuli Metsvaht, Nori Smeets, Karel Allegaert, Mark A Turner, Angela Amigoni, Athena F Zuppa, Saskia N de Wildt
Essentials of Translational Pediatric Drug Development – From Past Needs to Future Opportunities, 2024; Paperback ISBN: eBook ISBN:
EPTRI Special Issues
Special Issue entitled “Supporting the Pediatric Drug Development: From Basic Research to Clinical Studies and Technological Advancements” has been published in the Frontiers in Paediatrics Journal at the end of 2023 and beginning of 2024.
The Special Issue aiming to contribute to the international progress in paediatric research by supporting and facilitating the publication of high-quality studies on a variety of aspects of drug development that can have an impact on children’s therapeutics and health, has been addressed to all researchers and partners involved in the development of paediatric medicines working on the following topics:
1. Basic and pre-clinical research that provides new knowledge on human growth and ontogeny influencing drugs effects and drug development
2. Research on new biomarkers targeting common or rare paediatric diseases or diseases that can affect children as well as adults
3. Research on technologies, standardised models, and analytical tools/IT tools that can be applied in a paediatric setting (drugs and medical devices)
4. Modelling, simulation, and extrapolations methods applied to paediatric medicines developmental phases mainly devoted to the right dose identification and risk/benefit preclinical evaluation.
5. Innovative paediatric-tailored formulations, including 3D applications
6. Investigation & scrutiny of clinical and RWD data on the use of medicines in children and adolescents.
7. Research on the ethical and legal framework for paediatric studies including the consenting process, raising awareness and improving patients engagement in paediatric research
Eight articles were published in this Special Issue.
- Paediatric medicine issues and gaps from healthcare workers point of view: survey results and a narrative review from the global accelerator for paediatric formulations project, Elisa Barbieri, Chiara Minotti, Sara Cavagnis, Carlo Giaquinto, Bernadette Cappello, Martina Penazzato and Marc Lallemant. Front. Pharmacol. 2023 14:1200848. doi: 10.3389/fphar.2023.1200848
- Impact of vaccination with different types of rotavirus vaccines on the incidence of intussusception: a randomized controlled meta-analysis, Wang G, Zhang K, Zhang R, Kong X and Guo C. Front. Pharmacol. 2023 11:1239423. doi: 10.3389/fped.2023.1239423
- In vitro intestinal simulation system on the carbon source utilization characteristics and mechanism of interspecific syntrophic effects of Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330, Li J, Xu L, Liao J, Li X, Wang X, Wu Q and Zhu L. Front. Pharmacol. 2023 11:1276846. doi: 10.3389/fped.2023.1276846
- Pragmatic physiologically-based pharmacokinetic modeling to support clinical implementation of optimized gentamicin dosing in term neonates and infants: proof-of-concept, de Hoop-Sommen MA, van der Heijden JEM, Freriksen JJM, Greupink R and de Wildt SN. Front. Pharmacol. 2023 11:1288376. doi: 10.3389/fped.2023.1288376
- Development and performance of the c4c national clinical trial networks for optimizing pediatric trial facilitation, Degraeuwe E, van der Geest T, Persijn L, Nuytinck L, Raes A, Turner M, Fernandes RM, Vande Walle J, de Wildt SN and IMI2 project conect4children(c4c) consortium, including National Hubs/Networks Belgian Pediatric Clinical Research Network (BPCRN) (Belgium) and Pedmed-L (Netherlands). Front. Pharmacol. 2023 11:1302272. doi: 10.3389/fped.2023.1302272
- Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial, Chu T, Zhou S, Wan Y, Liu Q, Xin Y, Tian Z, Yan T and Xu A. Front. Pharmacol. 2024 15:1298409. doi: 10.3389/fphar.2024.1298409
- Evaluating palatability in young children: a mini-review of relevant physiology and assessment techniques, Schluterman HM, Linardos CG, Drulia T, Marshall JD and Kearns GL. Front. Pharmacol. 2024 12:1350662. doi: 10.3389/fped.2024.1350662
- Piperacillin/tazobactam treatment in children: evidence of subtherapeutic concentrations, Ye P, Shi J, Guo Z, Yang X, Li Q, Chen K, Zhao F, Zhou H, Zhang Y, van den Anker J, Song L and Zhao W. Front. Pharmacol. 2024 15:1254005. doi: 10.3389/fphar.2024.1254005
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Special Issue dedicated to the Scientific Highlights in the European Paediatric Translational Research Infrastructure has been published into the section “Drug Delivery and Controlled Release” of the Pharmaceutics Journal at the end of 2021.
The Special Issue has been addressed to all researchers and partners involved in the development of paediatric medicines working on the following topics: i) paediatric medicines drug targets and methods of identification; ii) advanced cellular/in vitro models for paediatric drug targeting; iii) paediatric formulations and toxicology of drugs; iv) drug delivery design in paediatrics; v) translational research.
The EPTRI members published 12 articles in this Special Issue.
- In Vivo Investigation of (2-Hydroxypropyl)-β-cyclodextrin-Based Formulation of Spironolactone in Aqueous Solution for Paediatric Use, Antonio Lopalco, Annachiara Manni, Alexander Keeley, Shozeb Haider, Wenliang Li, Angela Lopedota, Cosimo Damiano Altomare, Nunzio Denora, Catherine Tuleu. Pharmaceutics 2022, 14(4), 780; https://doi.org/10.3390/pharmaceutics14040780
- Intestinal Cellular Biomarkers of Mucosal Lesion Progression in Pediatric Celiac Disease, Serena Vitale, Mariantonia Maglio, Stefania Picascia, Ilaria Mottola, Erasmo Miele, Riccardo Troncone, Renata Auricchio, Carmen Gianfrani. Pharmaceutics 2021, 13(11), 1971; https://doi.org/10.3390/pharmaceutics13111971
- N2B-Selective Antagonist Ro 25-6981 Is Effective against PTZ-Induced Seizures and Safe for Further Development in Infantile Rats, Pavel Mareš, Lucie Kozlová, Anna Mikulecká, Hana Kubová. Pharmaceutics 2021, 13(9), 1482; https://doi.org/10.3390/pharmaceutics13091482
- Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure), Elisa Alessandrini, Francis Brako, Mariagiovanna Scarpa, Mariangela Lupo, Donato Bonifazi, Valeria Pignataro, Maria Cavallo, Ornela Cullufe, Cristina Enache, Begonya Nafria, Joana Claverol, Leen De Taeye, Eric Vermeulen, Jennifer Preston, Catherine Tuleu. Pharmaceutics 2021, 13(5), 730; https://doi.org/10.3390/pharmaceutics13050730
- Detection of Breathing Movements of Preterm Neonates by Recording Their Abdominal Movements with a Time-of-Flight Camera, Felix C. Wiegandt, David Biegger, Jacob F. Fast, Grzegorz Matusiak, Jan Mazela, Tobias Ortmaier, Theodor Doll, Andreas Dietzel, Bettina Bohnhorst, Gerhard Pohlmann. Pharmaceutics 2021, 13(5), 721; https://doi.org/10.3390/pharmaceutics13050721
- Breath-Triggered Drug Release System for Preterm Neonates, Felix C. Wiegandt, Ulrich P. Froriep, Fabian Müller, Theodor Doll, Andreas Dietzel, Gerhard Pohlmann. Pharmaceutics 2021, 13(5), 657; https://doi.org/10.3390/pharmaceutics13050657
- Anticonvulsant Action of GluN2A-Preferring Antagonist PEAQX in Developing Rats, Pavel Mares, Grygoriy Tsenov, Hana Kubova. Pharmaceutics 2021, 13(3), 415; https://doi.org/10.3390/pharmaceutics13030415
- Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies, Carsten W. Lederer, Lola Koniali, Tina Buerki-Thurnherr, Panayiota L. Papasavva, Stefania La Grutta, Amelia Licari, Frantisek Staud, Donato Bonifazi, Marina Kleanthous. Pharmaceutics 2022, 14(4), 793; https://doi.org/10.3390/pharmaceutics14040793
- Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities, Paul Dimitri, Valeria Pignataro, Mariangela Lupo, Donato Bonifazi, Maria Henke, Umberto M. Musazzi, Floris Ernst, Paola Minghetti, Davide F. Redaelli, Sophia G. Antimisiaris, Giovanni Migliaccio, Fedele Bonifazi, Luca Marciani, Aaron J. Courtenay, Nunzio Denora, Angela Lopedota. Pharmaceutics 2021, 13(12), 2178; https://doi.org/10.3390/pharmaceutics13122178
- Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review, Beate Aurich, Evelyne Jacqz-Aigrain. Pharmaceutics 2021, 13(5), 695; https://doi.org/10.3390/pharmaceutics13050695
- Patient-Derived Induced Pluripotent Stem Cells (iPSCs) and Cerebral Organoids for Drug Screening and Development in Autism Spectrum Disorder: Opportunities and Challenges, Chiara Villa, Romina Combi, Donatella Conconi, Marialuisa Lavitrano. Pharmaceutics 2021, 13(2), 280; https://doi.org/10.3390/pharmaceutics13020280
- The Neonatal and Juvenile Pig in Pediatric Drug Discovery and Development, Miriam Ayuso, Laura Buyssens, Marina Stroe, Allan Valenzuela, Karel Allegaert, Anne Smits, Pieter Annaert, Antonius Mulder, Sebastien Carpentier, Chris Van Ginneken, Steven Van Cruchten. Pharmaceutics 2021, 13(1), 44; https://doi.org/10.3390/pharmaceutics13010044