Biopharmaceutic Planning in Pediatric Drug Development

Author:

Purohit Vivek S.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference11 articles.

1. Pediatric Research Equity Act of 2007, Title IV. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf . Accessed on: 17 Jan 2012.

2. Best Pharmaceuticals for Children Act of 2007, Title V. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf . Accessed on 17 Jan 2012.

3. Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 12, 2006, on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf . Accessed on 17 Jan 2012.

4. Benedetti MS, Whomsley R, Baltes EL. Differences in absorption, distribution, metabolism and excretion of xenobiotics between the pediatric and adult populations. Expert Opin Drug Metab Toxicol. 2005;1(3):447–71.

5. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology—drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;359:1157–67.

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