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Books > Medicine > Clinical & internal medicine > Paediatric medicine
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Safety Efforts in Pediatric Drug Development (Hardcover, New)
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Safety Efforts in Pediatric Drug Development (Hardcover, New)
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This book focuses on the safety efforts being implemented in
paediatric drug development. Although children suffer from many of
the same diseases as adults and are often treated with the same
drugs, only about one-third of the drugs that are prescribed for
children have been studied and labelled for paediatric use. This
has placed children taking drugs for which there have not been
adequate paediatric drug studies at risk of being exposed to
ineffective treatment or receiving incorrect dosing. In order to
encourage the study of more drugs for paediatric use, Congress
passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to
provide marketing incentives to drug manufacturers for conducting
paediatric drug studies. Drug manufacturers may obtain six months
of additional market exclusivity for drugs on which they have
conducted paediatric studies in accordance with pertinent law and
regulations. This book also evaluates the impact of BPCA on
labelling drugs for paediatric use and the process by which the
labelling was changed, and illustrates the range of diseases
treated by the drugs studied under BPCA. Additionally this book
provides guidance on the role and timing of animal studies in the
non-clinical safety evaluation of therapeutics intended for the
treatment of paediatric patients. The guidance discusses some
conditions under which juvenile animals can be meaningful
predictors of toxicity in paediatric patients and makes
recommendations on non-clinical testing. This book consists of
public documents which have been located, gathered, combined,
reformatted, and enhanced with a subject index, selectively edited
and bound to provide easy access.
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