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Bioanalytical aspects and challenges in supporting pediatric drug development
Ist Teil von
Bioanalysis, 2020-11, Vol.12 (21), p.1505-1508
Ort / Verlag
London: Newlands Press Ltd
Erscheinungsjahr
2020
Link zum Volltext
Beschreibungen/Notizen
[...]physicians either did not administer potentially beneficial drugs to children or took the decision to treat them with a drug off-label (2). [...]the number of drugs with pediatric labeling has significantly increased and pharmaceutical companies include pediatric patients much earlier in drug development (5). To achieve this, preclinical safety, metabolism and PK needto be considered (including the conduct of juvenile toxicity studies), formulations adapted to pediatric use, the correct dose and dosing regimen established, appropriate sampling techniques definedand methods for data collection and evaluation developed (modeling and simulation, population PK). [...]the authors recommend comparing drug levels obtained from finger or heel prick sampling with venous collection.