Microdosing Studies in Children: A US Regulatory Perspective

Clinical Pharmacology and Therapeutics

Volumn 98, Issue 3, 2015, Pages 232-233

  Cline, M Roth ^a   Nelson, R M ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2D6; DEXTROMETHORPHAN; NEW DRUG; PARACETAMOL; DRUG;

BLOOD SAMPLING; CHILD CARE; CHILD HEALTH; DRUG DEVELOPMENT; DRUG DISPOSITION; DRUG DOSE; ENZYME ACTIVITY; FOOD AND DRUG ADMINISTRATION; HUMAN; NONHUMAN; NOTE; ONTOGENY; PHARMACOKINETICS; PRIORITY JOURNAL; RISK ASSESSMENT; UNNECESSARY PROCEDURE; AGE; CHILD; DOSE CALCULATION; DRUG APPROVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GOVERNMENT REGULATION; INFANT; LEGISLATION AND JURISPRUDENCE; METABOLISM; NEWBORN; PATIENT SAFETY; PHASE 1 CLINICAL TRIAL (TOPIC); PRESCHOOL CHILD; RISK FACTOR; UNITED STATES;

AGE FACTORS; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG APPROVAL; DRUG DOSAGE CALCULATIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GOVERNMENT REGULATION; HUMANS; INFANT; INFANT, NEWBORN; PATIENT SAFETY; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RISK ASSESSMENT; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84946401192     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.165     Document Type: Note

References (5)

1. Food and Drug Administration. Guidance for Industry, Investigators, and Reviewers, Exploratory IND Studies. . 2006 [cited December 1, 2014].
2. Institute of Medicine. IOM Committee on Clinical Research Involving Children: Ethical Conduct of Clinical Research Involving Children. 2010/07/30 ed. (Eds. Field, M. J., Behrman, R. E.) (National Academies Press Washington, DC, 2004).
3. Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. Meeting Transcript, Exploratory IND Studies in the Pediatric Population. . May 11, 2011 [cited December 1, 2014].
4. Mooij, M. G. et al. Pediatric microdose study of [(14)C]paracetamol to study drug metabolism using accelerated mass spectrometry: proof of concept. Clin. Pharmacokinet. 53, 1045-1051 (2014).
5. Blake, M. J. et al. Ontogeny of dextromethorphan O-and N-demethylation in the first year of life. Clin. Pharmacol. Ther. 81, 510-516 (2007).