Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates

Author:

Nellis Georgi,Metsvaht Tuuli,Varendi Heili,Lass Jana,Duncan Jennifer,Nunn Anthony J.,Turner Mark A.,Lutsar Irja

Funder

Estonian Research Council

ERA-NET PRIOMEDCHILD

Agence Nationale de la Recherche

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pediatrics, Perinatology, and Child Health

Reference36 articles.

1. Fabiano V, Mameli C, Zuccotti GV. Paediatric pharmacology: remember the excipients. Pharmacol Res. 2011;63:362–5.

2. Rowe CR, Sheskey JP, Cook GW, Fenton EM. Handbook of pharmaceutical excipients. 7th ed. London: Pharmaceutical Press and American Pharmacists Association; 2012.

3. European Medicines Agency. Reflection paper: formulations of choice for the paediatric population. 2006; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003782.pdf . Accessed 15 Mar 2016

4. Leeder JS, Kearns GL, Spielberg SP, van den Anker J. Understanding the relative roles of pharmacogenetics and ontogeny in pediatric drug development and regulatory science. J Clin Pharmacol. 2010;50:1377–87.

5. European Medicines Agency. Guideline on the investigation of medicinal products in the term and preterm neonate. 2009; http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003750.pdf . Accessed 15 Mar 2016

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