Pediatric Formulations - A Roadmap (Paperback, Softcover reprint of the original 1st ed. 2014)

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.

General

Imprint:	Springer-Verlag New York
Country of origin:	United States
Series:	AAPS Advances in the Pharmaceutical Sciences Series, 11
Release date:	August 2016
First published:	2014
Editors:	Daniel Bar-Shalom • Klaus Rose
Dimensions:	235 x 155 x 23mm (L x W x T)
Format:	Paperback
Pages:	439
Edition:	Softcover reprint of the original 1st ed. 2014
ISBN-13:	978-1-4939-4521-4
Categories:	Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing Books > Medicine > Clinical & internal medicine > Paediatric medicine > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	1-4939-4521-1
Barcode:	9781493945214

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