More medicines for children: impact of the EU paediatric regulation

Autor: Sofia Nordenmalm, Chrissi Pallidis, Paolo Tomasi

Publikováno v: Archives of Disease in Childhood. 103:557-564

IntroductionThis paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authori

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9fd0a57c0a6cacf13c9fecfc33567fdc
https://doi.org/10.1136/archdischild-2017-313309

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

Autor: Jean Temeck, Dianne Murphy, Irmgard Eichler, Dobromir Penkov, Lynne Yao, Paolo Tomasi

Publikováno v: Therapeutic Innovation & Regulatory Science. 51:360-371

Pediatric legislation in the US and the EU is driving pediatric product development on an international scale. To facilitate harmonization and global development of pediatric medicines, it is important to understand the legislative requirements that

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc3c20d7ec7b0ecf8efc4d7ba72c0767
https://doi.org/10.1177/2168479017696265

Expanding Treatment Options for Youth With Type 2 Diabetes: Current Problems and Proposed Solutions

Autor: Janina Karres, William V. Tamborlane, Paula H. Hale, Kathleen E. Bethin, Rose Gubitosi-Klug, Jeffrey L. Blumer, George P. Giacoia, Georgeanna J. Klingensmith, Paolo Tomasi, Morey W. Haymond, Michael D. Reed, R. Ravi Shankar, Ingrid Libman, Ronald J. Portman, David B. Dunger

Publikováno v: Diabetes Care. 39:323-329

The Best Pharmaceuticals for Children Act of 2002 mandated that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) carries out critical reviews of the gaps in knowledge and unmet needs regarding safe and effec

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::12084089d38563690a3fad7691884e19
https://doi.org/10.2337/dc15-1649

Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations

Autor: Andrea Ecker, Ingeborg Barišić, Koenraad Norga, Thomas Girard, Paolo Tomasi, Segundo Mariz, Bruno Sepodes, Dirk Mentzer, Frauke Naumann-Winter

Publikováno v: Archives of disease in childhood

BackgroundMarket forces may not be sufficient to stimulate research and development of medicines for small patient populations, such as children and patients with rare diseases. Both the European Union Orphan and Paediatric Regulations were introduce

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::20b03b6befb0f84411c8a7e29750092c
https://pubmed.ncbi.nlm.nih.gov/29089318

Identifying High-Risk Chronic Lymphocytic Leukemia: A Pathogenesis-Oriented Appraisal of Prognostic and Predictive Factors in Patients Treated with Chemotherapy with or without Immunotherapy

Autor: Paolo Tomasi, Luca Formigaro, Elena Saccenti, Maria Ciccone, Massimo Negrini, Elisa Tammiso, Enrico Lista, Maurizio Cavallari, Olga Sofritti, Antonio Cuneo, Sara Martinelli, Giulia Daghia, Francesco Cavazzini, Eleonora Volta, Francesca Maria Quaglia, Sabrina Moretti, Melissa Dabusti, Antonella Bardi, Gian Matteo Rigolin

Publikováno v: Mediterranean Journal of Hematology and Infectious Diseases
Mediterranean Journal of Hematology and Infectious Diseases, Vol 8, Iss 0, Pp e2016047-e2016047 (2016)

Chronic lymphocytic leukemia (CLL) displays an extremely variable clinical behaviour. Accurate prognostication and prediction of response to treatment is important in an era of effective first-line regimens and novel molecules for high risk patients.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0e58460c3a8186d24b7aad923833564b
http://europepmc.org/articles/PMC5111525