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Books > Medicine > Clinical & internal medicine > Paediatric medicine
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Pediatric Formulations - A Roadmap (Paperback, Softcover reprint of the original 1st ed. 2014)
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Pediatric Formulations - A Roadmap (Paperback, Softcover reprint of the original 1st ed. 2014)
Series: AAPS Advances in the Pharmaceutical Sciences Series, 11
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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 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.
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