Pubblicazioni

Articoli Scientifici

Target therapy for high-risk neuroblastoma treatment:integration of regulatory and scientific tools is needed

Ceci A, Conte R, Didio A, Landi A, Ruggieri L, Giannuzzi V and Bonifazi F. Target therapy for high-risk neuroblastoma treatment:integration of regulatory and scientific tools is needed. Front. Med. 2023;10:1113460. doi: 10.3389/fmed.2023.1113460

Collaborative approach to enhance the knowledge on paediatric rare diseases: the European Paediatric Translational Research Infrastructure. Meeting abstracts from the 11th edition of the European conference on Rare Diseases & Orphan Products (ECRD) 2022

Lucia Ruggieri, Adriana Ceci, Bonka Georgieva, Arianna Bertolani, Franco Bartoloni, Fedele Bonifazi, Giovanni Migliaccio, Annagrazia Altavilla, Oscar Della Pasqua, Emmanuel Mikros, Hana Kubova, Pierluigi Martelli, Karel Allegaert, Paul Dimitri, Frantisek Staud, Elke Smits, Marina Kleanthous, Sergio Giannattasio, Nunzio Denora, Catherine Tuleu, Donato Bonifazi. Collaborative approach to enhance the knowledge on paediatric rare diseases: the European Paediatric Translational Research Infrastructure. Meeting abstracts from the 11th edition of the European conference on Rare Diseases & Orphan Products (ECRD) 2022. Orphanet J Rare Dis 18 (Suppl 1), 118 (2023) P24. https://doi.org/10.1186/s13023-023-02707-4

Off-label is not always off-evidence: authorising paediatric indications for old medicines

de Wildt SN, Foeldvari I, Siapkara A, Lepola P, Kriström B, Ruggieri L, Eichler I, Egger GF. Off-label is not always off-evidence: authorising paediatric indications for old medicines. Lancet Child Adolesc Health. 2023 Apr 25:S2352-4642(23)00083-4. doi: 10.1016/S2352-4642(23)00083-4

Reviews in: Regulatory Science

Kerpel-Fronius S, Giannuzzi V, Stoyanova-Beninska V, Sun Z. Reviews in: Regulatory Science. Front. Med. Sec. Regulatory Science. Volume 10 - 2023. doi: 10.3389/fmed.2023.1206753

Moving towards a Question-centric approach for regulatory decision-making in the context of drug assessment

Musuamba Tshinanu F, Cheung SYA, Colin P, Davies EH, Barret JS, Pappalardo F, Chappell M, Dogne JM, Ceci A, Della Pasqua O, Rusten IS. Moving towards a Question-centric approach for regulatory decision-making in the context of drug assessment. Clin Pharmacol Ther. 2023 Jan 27. doi: 10.1002/cpt.2856

PedCRIN tool for the biosamples management in paediatric clinical trials

Giannuzzi V, Ruggieri L, Conte R, Manfredi C, Felisi M, Kubiak C, Matei M, Malik S, Demotes J, Ceci A, Bonifazi D. PedCRIN tool for the biosamples management in paediatric clinical trials. Clin Transl Sci. 2023 Feb 9. doi: 10.1111/cts.13489

The use of real world data for regulatory purposes in the rare diseases setting

Giannuzzi V, Stoyanova-Beninska V and Hivert V (2022) Editorial: The use of real world data for regulatory purposes in the rare diseases setting. Front. Pharmacol. 13:1089033. doi: 10.3389/fphar.2022.1089033

Random Forest Clustering Identifies Three Subgroups of β-Thalassemia with Distinct Clinical Severity

Vitrano A, Musallam KM, Meloni A, Addario Pollina S, Karimi M, El-Beshlawy A, Hajipour M, Di Marco V, Ansari SH, Filosa A, Ricchi P, Ceci A, Daar S, Vlachaki E, Singer ST, Naserullah ZA, Pepe A, Scondotto S, Dardanoni G, Bonifazi F, Sankaran VG, Vichinsky E, Taher AT, Maggio A, International Working Group on Thalassemia. Random Forest Clustering Identifies Three Subgroups of β-Thalassemia with Distinct Clinical Severity. Thalassemia Reports. 2022; 12(1):14-23. https://doi.org/10.3390/thalassrep12010004

Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018

Sultana J, Crisafulli S, Almas M, Antonazzo IC, Baan E, Bartolini C, Bertuccio MP, Bonifazi F, Capuano A, Didio A, Ehrenstein V, Felisi M, Ferrajolo C, Fontana A, Francisca R, Fourrier-Reglat A, Fortuny J, Gini R, Hyeraci G, Hoeve C, Kontogiorgis C, Isgrò V, Lalagkas PN, L'Abbate L, Layton D, Landi A, Narduzzi S, Pereira LR, Poulentzas G, Rafaniello C, Roberto G, Scondotto G, Sportiello L, Toma M, Toussi M, Verhamme K, Volpe E, Trifirò G. Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018. Pharmacoepidemiol Drug Saf. 2022 Jan 29. doi: 10.1002/pds.5413

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; the c4c HTA expert group. Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project. Br J Clin Pharmacol. 2021 Dec 20. doi: 10.1111/bcp.15190. Epub ahead of print. PMID: 34931373

Human Microbiome in Children, at the Crossroad of Social Determinants of Health and Personalized Medicine
Sainz T, Pignataro V, Bonifazi D, Ravera S, Mellado MJ, Pérez-Martínez A, Escudero A, Ceci A, Calvo C. Human Microbiome in Children, at the Crossroad of Social Determinants of Health and Personalized Medicine. Children. 2021; 8(12):1191. https://doi.org/10.3390/children8121191
Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities

Dimitri P, Pignataro V, Lupo, M, Bonifazi D, Henke M, Musazzi UM, Ernst F, Minghetti P, Redaelli DF, Antimisiaris SG, Migliaccio G, Bonifazi F, Marciani L, Courtenay AJ, Denora N, Lopedota A. Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities. Pharmaceutics 2021, 13, 2178. https://doi.org/10.3390/pharmaceutics13122178

Informed consent and assent guide for paediatric clinical trials in Europe
Lepola P, Kindred M, Giannuzzi V, Glosli H, Dehlinger-Kremer M, Dalrymple H, Neubauer D, Boylan GB, Conway J, Dewhurst J, Hoffman D. Informed consent and assent guide for paediatric clinical trials in Europe. Arch Dis Child 2021;0:1–9. doi:10.1136/archdischild-2021-322798
Primary HBB gene mutation severity and long-term outcomes in a global cohort of β-thalassaemia
Musallam KM, Vitrano A, Meloni A, Addario Pollina S, Di Marco V, Hussain Ansari S, Filosa A, Ricchi P, Ceci A, Daar S, Vlachaki E, Singer ST, Naserullah ZA, Pepe A, Scondotto S, Dardanoni G, Karimi M, El-Beshlawy A, Hajipour M, Bonifazi F, Vichinsky E, Taher AT, Sankaran VG, Maggio A; International Working Group on Thalassemia (IWG-THAL). Primary HBB gene mutation severity and long-term outcomes in a global cohort of β-thalassaemia. Br J Haematol. 2021 Oct 25. doi: 10.1111/bjh.17897. Epub ahead of print
Survival and causes of death in 2,033 patients with non-transfusion-dependent β-thalassemia
Musallam KM, Vitrano A, Meloni A, Pollina SA, Karimi M, El-Beshlawy A, Hajipour M, Di Marco V, Ansari SH, Filosa A, Ricchi P, Ceci A, Daar S, Vlachaki E, Singer ST, Naserullah ZA, Pepe A, Scondotto S, Dardanoni G, Bonifazi F, Sankaran VG, Vichinsky E, Taher AT, Maggio A. Survival and causes of death in 2,033 patients with non-transfusion-dependent β-thalassemia. Haematologica. 2021 Sep 1;106(9):2489-2492. doi: 10.3324/haematol.2021.278684. PMID: 33882642; PMCID: PMC8409024.
The International Hemoglobinopathy Research Network (INHERENT): An international initiative to study the role of genetic modifiers in hemoglobinopathies
Kountouris P, Stephanou C, Archer N, Bonifazi F, Giannuzzi V, Kuo KHM, Maggio A, Makani J, Mañú-Pereira MDM, Michailidou K, Nkya S, Nnodu OE, Trompeter S, Tshilolo L, Wonkam A, Zilfalil BA, Inusa BPD, Kleanthous M, on behalf of the International Hemoglobinopathy Research Network (INHERENT). The International Hemoglobinopathy Research Network (INHERENT): An international initiative to study the role of genetic modifiers in hemoglobinopathies. Am J Hematol. 2021 Aug 18. doi: 10.1002/ajh.26323. Epub ahead of print. PMID: 34406671
Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
Giannuzzi V, Felisi M, Bonifazi D, Devlieger H, Papanikolaou G, Ragab L, Fattoum S, Tempesta B, Reggiardo G, Ceci A. Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project. BMC Med Ethics. 2021 Apr 29;22(1):49. doi: 10.1186/s12910-021-00618-2. PMID: 33926431
Paediatric clinical research in Europe: an insight on experts' needs and perspectives
Ruggieri L, Ceci A, Bartoloni F, Elie V, Felisi M, Jacqz-Aigrain E, Lupo M, Malik S, Manfredi C, Reggiardo G, Demotes J, Bonifazi D. Paediatric clinical research in Europe: an insight on experts' needs and perspectives. Contemp Clin Trials Commun. 2021 Feb 10;21:100735. doi: 10.1016/j.conctc.2021.100735. PMID: 33665471; PMCID: PMC7905444.
The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children
Turner MA, Hildebrand H, Fernandes RM, de Wildt SN, Mahler F, Hankard R, Leary R, Bonifazi F, Nobels P, Cheng K, Attar S, Rossi P, Rocchi F, Clavero J, Nafria B, Giaquinto C. The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children. Pharm Med (2021). https://doi.org/10.1007/s40290-020-00373-6
Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?
Toma M, Felisi MG, Bonifazi D, Bonifazi F, Giannuzzi V, Reggiardo G, de Wildt S, Ceci A and TEDDY European Network of Excellence for Paediatric Research. Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?. Front. Med. 2021 Feb; 8:593281. doi: 10.3389/fmed.2021.593281
A complication risk score to evaluate clinical severity of thalassaemia syndromes
Vitrano A, Meloni A, Addario Pollina W, Karimi M, El-Beshlawy A, Hajipour M, Di Marco V, Hussain Ansari S, Filosa A, Ricchi P, Ceci A, Daar S, Titi Singer S, Naserullah ZA, Pepe A, Scondotto S, Dardanoni G, Bonifazi F, Vichinsky E, Maggio A. A complication risk score to evaluate clinical severity of thalassaemia syndromes. Br J Haematol. 2020 Nov 20. doi: 10.1111/bjh.17203. Epub ahead of print. PMID: 33216983.
European research networks to facilitate drug research in children

Turner M, Cheng K, de Wildt S, Hildebrand H, Attar S, Rossi P, Bonifazi D, Ceci A, Claverol J, Nafria B, Giaquinto C. European research networks to facilitate drug research in children. Br J Clin Pharmacol. 2020;1–9. DOI: 10.1111/bcp.14545.

Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial.

Maggio A, Kattamis A, Felisi M, Reggiardo G, El-Beshlawy A, Bejaoui M, Sherief L, Christou S, Cosmi C, Della Pasqua O, Del Vecchio G, Filosa A, Cuccia L, Hassab H, Kreka M, Origa R, Putti M, Spino M, Telfer P, Tempesta B, Vitrano A, Tsang YC, Zaka A, Tricta F, Bonifazi D, Ceci A. Evaluation of the efficacy and safety of deferiprone compared with deferasirox in paediatric patients with transfusion-dependent haemoglobinopathies (DEEP-2): a multicentre, randomised, open-label, non-inferiority, phase 3 trial. The Lancet. Haematology. Jun 2020; 7(6):e469-e478. DOI: 10.1016/s2352-3026(20)30100-9

Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance

Altavilla A, Giannuzzi A, Lupo M, Bonifazi D, Ceci A. Ethical, legal and regulatory issues of paediatric translational research call for an adequate model of governance. European Journal of Health Law. May 2020. 1–19. https://doi.org/10.1163/15718093-BJA10010

Machine Learning Systems Applied to Health Data and System

Bonifazi F, Volpe E, Digregorio G, Giannuzzi V, Ceci A. Machine Learning Systems Applied to Health Data and System. European Journal of Health Law 27. 2020; 1-17. doi: 10.1163/15718093-BJA10009

Different strategies to execute multi-database studies for medicines surveillance in real world setting: a reflection on the European model

Gini R, Sturkenboom M, Sultana J, Cave A, Landi A, Pacurariu A, Roberto G, Schink T, Candore G, Slattery J, Trifirò G, The Working Group 3 of ENCePP. Different strategies to execute multi-database studies for medicines surveillance in real world setting: a reflection on the European model. Clinical Pharmacology & Therapeutics. April 2020. doi:10.1002/cpt.1833

The Secondary Use of Paediatric Data Under GDPR: Looking for New Safeguards for Research

 Altavilla A, Herveg J, Giannuzzi V, Landi A, Ceci A. The Secondary Use of Paediatric Data Under GDPR: Looking for New Safeguards for Research. European Pharmaceutical Law Review. 2019; Volume 3, Issue 4.156 - 164. https://doi.org/10.21552/eplr/2019/4/6

Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe‐wide trials

Ruggieri L, Bonifazi D, Landi A, Bonifazi F, Bartoloni F, Costello M, Felisi MG, Gasthuys E, Godo A, Torres FM, Nadal D, Nuytinck L, Rocchi F, Turner M, Ceci A.. Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe‐wide trials. Acta Paediatrica. 2019;00:1–6. doi: 10.1111/apa.15020

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 LO, Roos M. The “A” of FAIR – As open as possible, as closed as necessary. Data Intelligence. 2020; 47–55. doi: 10.1162/dint_a_00027

International Comparison of Thalassemia Registries: Challenges and Opportunities

Nori T, Ghazisaeedi M, Aliabad GM, Mehdipour Y, Mehraeen E, Conte R, Safdari R, International Comparison of Thalassemia Registries: Challenges and Opportunities. ACTA INFORM MED. 2019 MAR 27(1): 58-63, doi: 10.5455/aim.2019.27.58-63

An overview of the efficacy and safety of deferiprone in paediatric patients with congenital haemoglobinopathies and chronic iron overload

Ceci A, Conte R, Didio A, Bonifazi D, Felisi M, Giannuzzi V, Bonifazi F. An overview of the efficacy and safety of deferiprone in paediatric patients with congenital haemoglobinopathies and chronic iron overload. Expert Opinion on Orphan Drugs. 2019; 7:4,181-197. doi: 10.1080/21678707.2019.1613977

9th European Conference on Rare Diseases & Orphan Products (ECRD Vienna 2018)

Giannuzzi V. Abandoned OMPs. 9th European Conference on Rare Diseases & Orphan Products (ECRD Vienna 2018). Orphanet Journal of Rare Diseases. 2018;13(S2)

Safe, Innovative and Accessible Medicines in Europe: A Renewed Strategy for Patients and the Pharmaceutical Sector

Altavilla A. Safe, Innovative and Accessible Medicines in Europe: A Renewed Strategy for Patients and the Pharmaceutical Sector. European Journal of Health Law. 2018;25(2):133-156. DOI: 10.1163/15718093-12520381

A Review on Impact of General Data Protection Regulation on Clinical Studies and Informed Consent

Giannuzzi V, Landi A, Bartoloni F, Ceci A. A Review on Impact of General Data Protection Regulation on Clinical Studies and Informed Consent. J Clin Res Bioeth 2018; 9(3):327. doi: 10.4172/2155-9627.1000327

Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey

Veal GJ, Malik S, Lupo M, MacFarlane S, Lepola P, Costello M, Ceci A, Boué C, Lecour C, Otto A, Rastegari M, Berry P. Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey. BMJ Paediatr Open. 2017 Sep 5;1(1):e000170 doi:  10.1136/bmjpo-2017-000170

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs

Giannuzzi V, Landi A, Bosone E, Giannuzzi F, Nicotri s, Torrent-Farnell J, Bonifazi F, Felisi M, Bonifazi D, Ceci A. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs. BMJ Open. 2017 Sep 11;7(9):e017358. doi: 10.1136/bmjopen-2017-017358

The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial

Neubert A, Baarslag MA, van Dijk M, van Rosmalen J, Standing JF, Sheng Y, Rascher W, Roberts D, Winslade J, Rawcliffe L, Hanning SM, Metsvaht T, Giannuzzi V, Larsson P, Pokorná P, Simonetti A, Tibboel D on behalf of CLOSED Consortium. The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 Nov 8;7(11):e016031corr1. PMID: 28637741; PMCID: PMC5726127.

Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen

Giannuzzi V, Conte R, Landi A, Ottomano SA, Bonifazi D, Baiardi P, Bonifazi F, Ceci A. Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen. Orphanet J Rare Dis.2017 Apr 3;12(1):64

The ethical framework for performing research with rare inherited neurometabolic disease patients

Giannuzzi V, Devlieger H, Margari L, Odlind V, Ragab L, Bellettato C et al. The ethical framework for performing research with rare inherited neurometabolic disease patients. Eur J Pedatr. 2017 Mar;176(3):395-405

Pattern of complications and burden of disease in patients affected by beta thalassemia major

Bonifazi F, Conte R, Baiardi P, Bonifazi D, Felisi M, Giordano P, Giannuzzi V, Iacono A, Padula R, Pepe A, Putti MC, Ruggieri L, Del Vecchio GC, Filosa A, Maggio A, Ceci A on behalf of the HTA-THAL Multiregional Registry.  Pattern of complications and burden of disease in patients affected by beta thalassemia major. Curr Med Res Opin. 2017 33(8):1525-1533

Formulating Medicines for children: challenges and issues - La Chimica e l'Industria (3): 2016

D'Andria P, Giannuzzi V, Bonifazi F, Ceci A, Denora N, Altomare C. Formulating Medicines for children: challenges and issues. La Chimica e l'Industria (3): 2016

The Italian multiregional thalassemia registry: Centers characteristics, services, and patients' population. Hematology

Conte R, Ruggieri L, Gambino A, Bartoloni F, Baiardi P, Bonifazi D, Bonifazi F, Felisi M, Giannuzzi V, Padula R, Pepe A, Putti MC, Del Vecchio GC, Maggio A, Filosa A, Iacono A, Mangiarini L, Ceci A. The Italian multiregional thalassemia registry: Centers characteristics, services, and patients' population. Hematology. 2016 Aug;21(7):415-24

Clinical Trial Application in Europe: What Will Change with the New Regulation? Sci Eng Ethics

Giannuzzi V, Altavilla A, Ruggieri L, Ceci A. Clinical Trial Application in Europe: What Will Change with the New Regulation? Sci Eng Ethics. 2016 Apr;22(2):451-66

Safety Profile of Oral Iron Chelator Deferiprone in Chinese Children with Transfusion-Dependent Thalassaemia

Botzenhardt S, Sing CW, Wong IC, Chan GC, Wong LY, Felisi M, Rascher W, Ceci A, Neubert A. Safety Profile of Oral Iron Chelator Deferiprone in Chinese Children with Transfusion-Dependent Thalassaemia. Curr Drug Saf. 2016;11(2):137-44

Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders

Cassis L, Cortès-Saladelafont E, Molero-Luis M, Yubero D, González MJ, Ormazábal A, Fons C, Jou C, Sierra C, Ponce EC, Ramos F, Armstrong J, O'Callaghan MM, Casado M, Montero R, Meavilla-Olivas S, Artuch R, Barić I, Bartoloni F, Bellettato CM, Bonifazi F, Ceci A, Cvitanović-Šojat L, Dali CI, D'Avanzo F, Fumic K, Giannuzzi V, Lampe C, Scarpa M, Garcia-Cazorla Á Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders. Orphanet J Rare Dis. 2016; 11: 147. doi:  10.1186/s13023-016-0431-1dis

Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

Ruggieri L, Giannuzzi V, Baiardi P, Bonifazi F, Davies EH, Giaquinto C, Bonifazi D, Felisi M, Chiron C, Pressler R, Rabe H, Whitaker MJ, Neubert A, Jacqz-Aigrain E, Eichler I, Turner MA, Ceci A; on behalf of the GRiP Consortium. Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines. Eur J Pediatr. 2015; 174(4):481-91

La Rete regionale degli acquisti della Regione Basilicata dall’Health technology assessment alla spesa: presentazione di un case study.

Lorusso S, Chiarolla E, Bonifazi F, Casino D, Sassano S. La Rete regionale degli acquisti della Regione Basilicata dall’Health technology assessment alla spesa: presentazione di un case study. Politiche Sanitarie. 2015;16(2):139-149

Multidisciplinary care in haemoglobinopathies. Thalassemia Reports

Ceci A, Mangiarini L, Bonifazi F, Conte R. Multidisciplinary care in haemoglobinopathies. Thalassemia Reports. 2014; 4:4875

Iron chelation therapy in thalassemia major: A systematic review with meta-analyses of 1520 patients included on randomized clinical trials

Maggio A, Filosa A, Vitrano A, Aloj G, Kattamis A, Ceci A, Fucharoen S, Cianciulli P, Grady RW, Prossomariti L, Porter JB, Iacono A, Cappellini MD, Bonifazi F, Cassarà F, Harmatz P, Wood J, Gluud C. Iron chelation therapy in thalassemia major: A systematic review with meta-analyses of 1520 patients included on randomized clinical trials. Blood Cells Mol Dis. 2011 Oct 15;47(3):166-75

The management of iron chelation therapy: preliminary data from a national registry of thalassaemic patients

Ceci A, Mangiarini L, Felisi M, Bartoloni F, Ciancio A, Capra M, D'Ascola D, Cianciulli P, Filosa A. The management of iron chelation therapy: preliminary data from a national registry of thalassaemic patients. Anemia. 2011;2011:435683

Personalised medicine in paediatrics: individualising treatment in children with rare neurological diseases

Scarpa M, Ceci A, Tomanin R, Mincarone P, Begley D. Personalised medicine in paediatrics: individualising treatment in children with rare neurological diseases. EPMA J. 2011 Jun; 2(2): 231–239

Survey of the presence of patulin in fruit juices

Bonerba E, Ceci E, Conte R, Tantillo G. Survey of the presence of patulin in fruit juices. Food Addit Contam Part B Surveill. 2010;3(2):114‐9

Assessment of dietary intake of patulin from baby foods

Bonerba E, Conte R, Ceci E, Tantillo G. Assessment of dietary intake of patulin from baby foods. J Food Sci. 2010 Sep;75(7):T123‐5

Availability of medicines for rare diseases in EU countries

Trama A, Pierannunzio D, Loizzo A, Taruscio D, Ceci A. Availability of medicines for rare diseases in EU countries. Pharmaceuticals Policy and Law, 2009;11(1,2):101-9

Clinical trials for paediatric medicines in Europe

Baiardi P, Girotto S, Della Pasqua O, Harper L, Grosch-Worner I, Ceci A, Giaquinto C. Clinical trials for paediatric medicines in Europe. Pharmaceuticals Policy and Law, 2009;11(1,2):71-78

Recommendation for drug development for children

Catapano M, Manfredi C, Paolucci P, Cross H, Verhamme K, Mellado Pena MJ, Grosch-Worner I, Knibbe C, Ceci A. Recommendation for drug development for children. Pharmaceuticals Policy and Law, 2009;11(1,2):61-70

The role of paediatric pharmacogenetic studies in Europe

Krekels E, Ceci A, Iolascon A, Girotto S, Della Pasqua O. The role of paediatric pharmacogenetic studies in Europe. Pharmaceuticals Policy and Law, 2009;11(1,2):23-30

Off-label and unlicensed use of medicines for children

Neubert A, Felisi M, Bonifazi A, Manfredi C, Wong ICK, Ceci A. Off-label and unlicensed use of medicines for children. Pharmaceuticals Policy and Law, 2009;11(1,2):41-49

Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey

Neubert A, Wong IC, Bonifazi A, Catapano M, Felisi M, Baiardi P, Giaquinto C, Knibbe CA, Sturkenboom MC, Ghaleb MA, Ceci A. Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey. Pharmacol Res. 2008 Nov-Dec;58(5-6):316-22

Drugs and food supplements in sports. The nandrolone lessons

Benzi G, Ceci A. Drugs and food supplements in sports. The nandrolone lessons. Minerva Pediatr. 2001 Oct;53(5):395-6

Creatine as nutritional supplementation and medicinal product

Benzi G, Ceci A. Creatine as nutritional supplementation and medicinal product. J Sports Med Phys Fitness. 2001 Mar;41(1):1-10

books

Sperimentazione clinica in pediatria

Ceci A, Giannuzzi V. Sperimentazione clinica in pediatria. In: Manuale Pratico di Sperimentazione Clinica/2 edizione, capitolo 5 – Mattioli Ed 2016; (ISBN: 978-88-6261-519-8)

Clinical Trials in Paediatrics — Regulatory and Methodological Aspects

Ceci A, Giannuzzi V, Bonifazi D, Felisi M, Bonifazi F, Ruggieri L. Clinical Trials in Paediatrics — Regulatory and Methodological Aspects. In: Drug Discovery and Development - From Molecules to Medicine. Intech 2015;(12):272-297. (ISBN 978-953-51-2128-2)

L'utilizzo dei farmaci off-label in pediatria

Ceci A, Ruggieri L. L'utilizzo dei farmaci off-label in pediatria. Argomenti di Pediatria Ospedaliera 2014:62-73

Elementi di farmacologia pediatrica

Ceci A, Giannuzzi V. Elementi di farmacologia pediatrica. In: Bartolozzi Pediatria. Principi e Pratica Clinica, IV ed. Milano, EDRA. Masson 2013;75-86. (ISBN 978-8821432873)

Farmacognosia - Botanica, chimica e farmacologia delle piante medicinali

Capasso, Grandolini.  Farmacognosia - Botanica, chimica e farmacologia delle piante medicinali. Springer-Verlag Italia S.r.l. (2011)

Innovative medicine: the science and the regulatory framework

Valverde JL, Ceci A (Eds). The EU Paediatric Regulation. In: Pharmaceuticals Policy and Law 2009;11(1,2). (ISBN 978-1607500117)

The EU Paediatric Regulation

Valverde JL, Ceci A (Eds). The EU Paediatric Regulation. In: Pharmaceuticals Policy and Law 2009;11(1,2). (ISBN 978-1607500117)

La sperimentazione in pediatria

Ceci A. La sperimentazione in pediatria. In: Manuale di Bioetica per la Sperimentazione clinica e i Comitati Etici. C.G Edizioni Medico Scientifiche (eds) 2008;(14)415-37. (ISBN 88-7110-145-6)

Gli aspetti medico biologici

Ceci A. Gli aspetti medico biologici. In: Ministero della Pubblica Istruzione. “Prevenire il Doping tra gli studenti” Manuale per gli insegnanti. Roma 2001;119-170

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