Articles in Journal
2025
On mobility and gait in scoliosis patients: a comparison of conventional and 3D-printed braces during an instrumented timed-up and go test
Costantini S., Redaelli D.F., Fraschini P., Biffi E., Storm F.A
BMC Musculoskeletal Disorders, 26 (1), art. no. 86. doi: 10.1186/s12891-025-08311-w
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Biodegradable ultrahigh-purity magnesium and its alloy ZX00 promote osteogenesis in the medullary cavity and glycogenolysis in the liver
Okutan B et al.
Acta Biomaterialia 195 (2025) 599–613 https://doi.org/10.1016/j.actbio.2025.02.007
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Adults with achondroplasia exhibit a high probability of specific micronutrient inadequacy and low physical activity levels: a cross-sectional study
Alves, I., Castro, M.A., Tavares, S. et al.
J Rare Dis 4, 45 (2025). https://doi.org/10.1007/s44162-025-00109-7
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Limb lengthening in individuals with achondroplasia: Analysis of an international survey
Beger, C.; Alves, I.; Carl-Innig, P.; Sessa, M.; Mohnike, K.; Cheung, M.S
Bone 2025, 117462, https://doi.org/10.1016/j.bone.2025.117462.
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Transition Care for Young Persons with Rare Bone Mineral Conditions: A Consensus Recommendation from the ECTS Rare Bone Disease Action Group
Grasemann C, Wernsmann J, Appelman-Dijkstra NM, Morgan C, Sylvest TT, Raimann A, Siggelkow H, Lems WF, Turan S, Zillikens MC, Wekre LL, Alves I, Solal MC, Yavropoulou MP, Clunie G
Calcif Tissue Int. 2025 May 9;116(1):73. doi: 10.1007/s00223-025-01382-w.
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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Neonatal Clinical Phrmacology
Allegaert K, Yalcin N, Flint B R, Simons HPS
Children (Basel) 2024 Sep 9;11(9):1102. doi: 10.3390/children11091102.
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Forecasting SARS-CoV-2 epidemic dynamic in Poland with the pDyn agent-based model
Niedzielewski K., Bartczuk RP., Bielczyk N., et al
Epidemics. 2024;49:100801. doi: 10.1016/j.epidem.2024.100801
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Assessment of Dried Serum Spots (DSS) and Volumetric-Absorptive Microsampling (VAMS) techniques in therapeutic drug monitoring of (Val)Ganciclovir-comparative study in analytical and clinical practice
Kocur A., Czajkowska A., Moczulski M., Kot B., Rubik J., Pawiński T
International Journal of Molecular Sciences. Vol. 25, Nr 16, Article 8760. doi: 10.3390/ijms25168760
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Neuroscientist’s Behavioral Toolbox for Studying Episodic-Like Memory
Kunčická D, Krajčovič B, Stuchlík A, Brožka H.
eNeuro. 2024;11(8):ENEURO.0073-24.2024. doi: 10.1523/ENEURO.0073-24.2024.
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Artificial intelligence tools for engagement prediction in neuromotor disorder patients during rehabilitation
Costantini S., Falivene A., Chiappini M., Malerba G., Dei C., Bellazzecca S., Storm F.A., Andreoni G., Ambrosini E., Biffi E
Journal of NeuroEngineering and Rehabilitation, 21 (1), art. no. 215. doi: 10.1186/s12984-024-01519-2
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Gait characterization in rare bone diseases in a real-world environment – A comparative controlled study
Fink S, Suppanz M, Oberzaucher J, Castro MA, Fernandes O, Alves I.
Gait Posture. 2024 Jul; 112:174-180. doi 10.1016/j.gaitpost.2024.05.033. Epub 2024 Jun 1
2023
Pharmacokinetics of the most commonly used antihypertensive drugs throughout pregnancy methyldopa, labetalol, and nifedipine: a systematic review
Dylan van de Vusse, Paola Mian, Sam Schoenmakers, Robert B. Flint, Willy Visser, Karel Allegaert, Jorie Versmissen
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PedCRIN tool for the biosamples management in pediatric clinical trials
Giannuzzi V, Ruggieri L, Conte R, Manfredi C, Felisi M, Kubiak C, Matei M, Malik S, Demotes J, Ceci A, Bonifazi D
Clin Transl Sci. 2023 Feb 9. doi: 10.1111/cts.13489.
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The role of optogenetic stimulations of parvalbumin-positive interneurons in the prefrontal cortex and the ventral hippocampus on an acute MK-801 model of schizophrenia-like cognitive inflexibility
Patrono E, Hrůzova K, Svoboda J, Stuchlík A
Schizophr Res. 2023;252:198-205. doi: 10.1016/j.schres.2022.12.047.
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Baseline EEG in the first year of life: Preliminary insights into the development of autism spectrum disorder and language impairments
Piazza, C., Dondena, C., Riboldi, E. M., Riva, V., & Cantiani, C.
Iscience, 26(7). https://doi.org/10.1016/j.isci.2023.106987
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Degradation behavior and osseointegration of Mg-Zn-Ca screws in different bone regions of growing sheep: a pilot study
Marek R et al
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/
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Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project
Moretti F, Ruiz F, Bonifazi F, Pizzo E, Kindblom JM; c4c HTA expert group
Br J Clin Pharmacol. 2022 Dec;88(12):5052-5059. doi: 10.1111/ bcp.15190. Epub 2022 Jan 28
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Implant degradation of low-alloyed Mg–Zn–Ca in osteoporotic, old and juvenile rats
N.G. Sommer, D. Hirzberger, L. Paar et al.
Acta Biomaterialia 147 (2022) 427–438 https://doi.org/10.1016/j.actbio.2022.05.041
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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Paediatric medicines in Europe: The Paediatric Regulation-Is It Time for Reform?
Toma M, Felisi M, Bonifazi D, Bonifazi F, Giannuzzi V, Reggiardo G, de Wildt S, Ceci A; TEDDY European Network of Excellence for Paediatric Research
Front Med (Lausanne). 2021 Feb 2;8:593281. doi: 10.3389/fmed.2021.593281.
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Selective deficits in attentional set-shifting in mice induced by maternal immune activation with poly(I:C)
Maleninska K, Janikova M, Radostova D, Vojtechova I, Petrasek T, Kirdajova D, Anderova M, Svoboda J, Stuchlik A
Behav Brain Res. 2021 Nov 25;419: 113678. doi: 10.1016/j.bbr.2021.113678.
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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The “A” of FAIR – As open as possible, as closed as necessary
Landi A, Thompson M, Giannuzzi V, Bonifazi F, Labastida I, Bonino da Silva Santos L.O, Roos M
Data Intelligence. 2(2020), 47–55. doi: 10.1162/dint_a_00027
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A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model
P. Holweg, L. Berger, M. Cihova et al
Acta Biomaterialia 113 (2020) 646–659 https://doi.org/10.1016/j.actbio.2020.06.013
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Establishing the first pan-European Registry for rare bone and mineral disorders: EuRR-Bone
Grasemann, Corinna & Mordenti, Marina & Alves, Inês & Skarberg, Rebecca & Soucek, Ondrej & Roos, Marco & Javaid, M. & Ahmed, Faisal & Lignart, Agnès & Mohnike, Klaus & Högler, Wolfgang & Sangiorgi, Luca & Appelman-Dijkstra, Natasha
Bone Reports. 13. 100318. doi 10.1016/j.bonr.2020.100318.
2018
Drug evaluation in children 10years after the European pediatric regulation current challenges and perspectives
Chapter in book
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 “Paediatric and Orphan Medical Devices: From Concept to Care—Transforming Innovation for Children’s Health” in Frontiers in Medicine – Regulatory Science is accepting papers.
This Special Issue introduced and supported by the European Pediatric Translational Research Infrastructure (EPTRI-AISBL), that aims to address the challenges faced today in pediatric medical device development and the DeCODe Project, and focusses on:
– Digital technologies for mental health in children and young people
– Digital technologies for the delivery of paediatric medicines
– Digital technologies and medial devices for rare disorders
– Medical devices and technologies to support long term conditions in childhood
– Medical devices for transition in paediatric healthcare
– Neonatal technologies
– Artificial intelligence in paediatrics and child health
– Access to digital technologies and medical devices
– Infrastructure to support child health technology development
– Addressing digital poverty and health inequalities in paediatric healthcare
– Health technologies for children and young people in low and middle income settings
We encourage contributions across a range of article types, ensuring a comprehensive exploration of innovations and solutions in this emerging field.
Manuscript Summary Submission Deadline 17 September 2025
Manuscript Submission Deadline 4 January 2026
More information on the submission process is available here.
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
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