Searching for just a few words should be enough to get started. If you need to make more complex queries, use the tips below to guide you.
Article type: Research Article
Authors: Catapano, M. | Manfredi, C. | Paolucci, P. | Cross, H. | Verhamme, K. | Mellado Peña, M.J. | Grosch-Wörner, I. | Knibbe, C. | Ceci, A.
Affiliations: Consorzio per Valutazioni Biologiche e Farmacologiche, Pavia, Italy | Department of Mother and Child, University of Modena and Reggio Emilia, Modena, Italy | University College London, London, UK | Pharmacoepidemiology Unit, Departments of Medical Informatics and Epidemiology & Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands | Department of Paediatrics, Hospital Carlos III, Madrid, Spain | Charité Universitätsmedizin Berlin, Berlin, Germany | Department of Clinical Pharmacology, San Antonio Hospital, Niewegein, The Netherlands
Note: [] Corresponding author: Adriana Ceci, Consorzio per Valutazioni Biologiche e Farmacologiche, Via Palestro 26, 27100 Pavia, Italy. Tel.: +39 0382 25075; Fax: +39 0382 536544; E-mail: aceci@cvbf.net
Abstract: One of TEDDY objectives is to "to identify unmet therapeutic needs for the development and use of medicinal products in male/female children" and it is compliant with the new provisions established by the Paediatric Regulation. Thus TEDDY set up 12 Therapeutic Experts Groups (TEGs) to identify the needs in some therapeutic areas of paediatric interest. Starting from the Assessment Documents released by EMEA-PEG and later on by EMEA-PDCO, a total of 14 therapeutic areas were analysed. TEDDY experts have identified 442 products that need to be specifically developed for children by either extending the current authorised indication or developing new indications. Moreover, the study shows that a total of 1480 studies (i.e. PK, dosage, efficacy, safety or long term safety) should be conducted in order to develop more drugs for children. In the light of these results, it is reasonable to question if all these studies are absolutely necessary and consequently if there are enough children to be enrolled in the trials for the same therapeutic area. It is imperative to adopt a procedure of selecting which drugs need to be developed for each therapeutic area in order to avoid repetitive and unnecessary trials in children.
Keywords: TEDDY, children, drug development, therapeutic needs, priority lists
DOI: 10.3233/PPL-2009-0207
Journal: Pharmaceuticals, Policy and Law, vol. 11, no. 1-2, pp. 61-70, 2009
IOS Press, Inc.
6751 Tepper Drive
Clifton, VA 20124
USA
Tel: +1 703 830 6300
Fax: +1 703 830 2300
sales@iospress.com
For editorial issues, like the status of your submitted paper or proposals, write to editorial@iospress.nl
IOS Press
Nieuwe Hemweg 6B
1013 BG Amsterdam
The Netherlands
Tel: +31 20 688 3355
Fax: +31 20 687 0091
info@iospress.nl
For editorial issues, permissions, book requests, submissions and proceedings, contact the Amsterdam office info@iospress.nl
Inspirees International (China Office)
Ciyunsi Beili 207(CapitaLand), Bld 1, 7-901
100025, Beijing
China
Free service line: 400 661 8717
Fax: +86 10 8446 7947
china@iospress.cn
For editorial issues, like the status of your submitted paper or proposals, write to editorial@iospress.nl
如果您在出版方面需要帮助或有任何建, 件至: editorial@iospress.nl