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Expert Opinion on Investigational Drugs Volume 5, 1996 - Issue 1
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Original Article

Clinical Perspective Paediatric clinical pharmacology: Reclaiming the therapeutic orphan

Henry C Farrar Section on Pediatric Clinical Pharmacology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
,
Thomas G Wells Section on Pediatric Clinical Pharmacology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
&
Gregory L Kearns Section on Pediatric Clinical Pharmacology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
Pages 7-13 | Published online: 03 Mar 2008

References

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  • KAUFFMAN RE, KEARNS GL: Pharmacolcinetic studies in espaediatric patients: clinical and ethical considerations.Clin. Pharmacokinet. (1992) 23(1):10–29. A practical review of the techniques to ensure the successful completion of ethically defensible studies.
  • FOOD AND DRUG ADMINISTRATION: 21 CFR Part 201: Specific requirements on content and format of label-ing for human prescription drugs; revision of the pediatric use subsection in the labeling. Federal Register (1994) 59(238):64240–64250
  • COMMIITEE ON BIOETHICS: Informed consent, paren- atal permission and assent in pediatric practice. Pediatr. (1995) 95(2):314–317. A clear definition of the process of obtaining informed consent in paediatrics.

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