An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics
In recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an i...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-04-01
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| Series: | Medicina |
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| Online Access: | https://www.mdpi.com/1648-9144/58/5/625 |
| _version_ | 1827668028670607360 |
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| author | Roberto Bernardini Gaia Toschi Vespasiani Arianna Giannetti |
| author_facet | Roberto Bernardini Gaia Toschi Vespasiani Arianna Giannetti |
| author_sort | Roberto Bernardini |
| collection | DOAJ |
| description | In recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an important public health issue, especially for children with rare conditions or with diseases not responsive to conventional treatments. The present paper is a narrative review of the literature of off-label drug use in children. The aim of our study is to summarize the main works dealing with the off-label use of biological drugs in paediatrics. Further studies analyzing their efficacy, safety, and cost–benefit ratios are needed to extend the use of biological therapies to the paediatric population. |
| first_indexed | 2024-03-10T03:28:28Z |
| format | Article |
| id | doaj.art-ea478b8e84574e86ae24bde64939a3dd |
| institution | Directory Open Access Journal |
| issn | 1010-660X 1648-9144 |
| language | English |
| last_indexed | 2024-03-10T03:28:28Z |
| publishDate | 2022-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Medicina |
| spelling | doaj.art-ea478b8e84574e86ae24bde64939a3dd2023-11-23T12:03:33ZengMDPI AGMedicina1010-660X1648-91442022-04-0158562510.3390/medicina58050625An Overview of Off-Label Use of Humanized Monoclonal Antibodies in PaediatricsRoberto Bernardini0Gaia Toschi Vespasiani1Arianna Giannetti2Paediatrics and Neonatology Unit, San Giuseppe Hospital, 50053 Empoli, ItalySpecialty School of Paediatrics, Alma Mater Studiorum, University of Bologna, 40138 Bologna, ItalyPaediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, ItalyIn recent years, off-label and unlicensed drug use has extensively developed in the paediatric population. For a long time, clinical trials in the paediatric population were considered complicated to perform because of ethical problems, causing frequent off-label use. Off-label drug use remains an important public health issue, especially for children with rare conditions or with diseases not responsive to conventional treatments. The present paper is a narrative review of the literature of off-label drug use in children. The aim of our study is to summarize the main works dealing with the off-label use of biological drugs in paediatrics. Further studies analyzing their efficacy, safety, and cost–benefit ratios are needed to extend the use of biological therapies to the paediatric population.https://www.mdpi.com/1648-9144/58/5/625off-labelhumanized monoclonal antibodiespaediatricschildrenomalizumabmepolizumab |
| spellingShingle | Roberto Bernardini Gaia Toschi Vespasiani Arianna Giannetti An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics Medicina off-label humanized monoclonal antibodies paediatrics children omalizumab mepolizumab |
| title | An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics |
| title_full | An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics |
| title_fullStr | An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics |
| title_full_unstemmed | An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics |
| title_short | An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics |
| title_sort | overview of off label use of humanized monoclonal antibodies in paediatrics |
| topic | off-label humanized monoclonal antibodies paediatrics children omalizumab mepolizumab |
| url | https://www.mdpi.com/1648-9144/58/5/625 |
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