Publications

Scientific Papers

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

Giannuzzi V. 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; 7(6): e016031.doi: 10.1136/bmjopen-2017-016031

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).
Innovative medicine: the science and the regulatory framework.
In: Pharmaceuticals Policy and Law 2010;12(1,2). (ISBN 978-1607506027)
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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