9781493945214 - pediatric formulations: a roadmap: 11 (10 risultati)
Lingua: Inglese
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Lingua: Inglese
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Serie: Libro 10 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Altre immaginiLingua: Inglese
Editore: Springer Nature B.V., 2016
Serie: Libro 10 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Taschenbuch. Condizione: Neu. Pediatric Formulations | A Roadmap | Daniel Bar-Shalom (u. a.) | Taschenbuch | xv | Englisch | 2016 | Springer Nature B.V. | EAN 9781493945214 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
Lingua: Inglese
Editore: Springer New York, 2016
Serie: Libro 10 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Taschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulat…ions in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.
Lingua: Inglese
Editore: Springer, 2016
Serie: Libro 10 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Editore: Springer US, Springer New York Aug 2016, 2016
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Taschenbuch. Condizione: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appr…opriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed. 456 pp. Englisch.
Lingua: Inglese
Editore: Springer, 2016
Serie: Libro 10 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Lingua: Inglese
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Serie: Libro 10 di 38 - AAPS Advances in the Pharmaceutical Sciences
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