Pediatric Drug Development

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Pediatric Drug Development by Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis, Wiley
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Author: Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis ISBN: 9781118312056
Publisher: Wiley Publication: May 20, 2013
Imprint: Wiley-Blackwell Language: English
Author: Andrew E. Mulberg, Dianne Murphy, Julia Dunne, Lisa L. Mathis
ISBN: 9781118312056
Publisher: Wiley
Publication: May 20, 2013
Imprint: Wiley-Blackwell
Language: English

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions.

Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.

This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally.

From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions.

Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations.

This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally.

From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.

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