Clinical research in newborn infants: difficulties and specificity

Author:

Ligi Isabelle,Boubred Farid,Grandvuillemin Isabelle,Simeoni Umberto

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference16 articles.

1. Conroy S, McIntyre J, Choonara I (1999) Unlicensed and off-label drug use in neonates. Arch Dis Child Neonatal Ed 80:F142–F145

2. Sammons H (2006) Ethical considerations for clinical trials on medicinal products with the paediatric population. Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/ethical_considerations.pdf .

3. Sutherland J (1959) Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol. Am J Dis Child 18:761–767

4. Silverman W et al (1956) A different mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens. Pediatrics 18:614–621

5. Committee for Medicinal Products for Human Use (2007) Guideline on the investigation of medicinal products in the term and preterm neonate. http://www.emea.europa.eu

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