Pediatric Mïcrodose and Microtracer Studies Using 14C in Europe

article












Turner, M.A.

Mooij, M.G.

Vaes, W.H.J.

Windhorst, A.D.

Hendrikse, N.H.

Knibbe, C.A.J.

Körgvee, L.T.

Maruszak, W.

Grynkiewicz, G.

Garner, R.C.

Tibbocl, D.

Park, B.K.

Wildt, S.N. de
Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientifîc chaflenges One barrier to the evaluation of medicines for children is a lack of Innovative methodologies that have been adapted to the needs of chiIdren This article presents our successful experience of pediatric microdose and microtracer studies using ‘4C-Iabeled probes in Europe to iflustrate the strengths and limitations of these approaches.
Topics
































CarbonDrugAgeDose calculationDose responseDrug-Related Side Effects and Adverse ReactionsEconomicsEthicsLegislation and jurisprudenceMetabolismNewbornPhase 1 clinical trial (topic)Preschool childAge FactorsCarbon RadioisotopesChildChild, PreschoolClinical Trials, Phase I as TopicDose-Response Relationship, DrugDrug ApprovalDrug CostsDrug Dosage CalculationsDrug-Related Side Effects and Adverse ReactionsEuropeGovernment RegulationHumansInfantInfant, NewbornPatient SafetyPharmaceutical PreparationsPharmacokineticsRisk AssessmentRisk Factors
TNO Identifier
528505
Repository link
https://resolver.tno.nl/uuid:26814d1b-b57f-4021-9a19-2020ad1092b5
Source
Clinical Pharmacology & Therapeutics, 98(3), pp. 234-237.
Pages
234-237
Files
To receive the publication files, please send an e-mail request to TNO Repository.