Details

Autor(en) / Beteiligte

• Heinig, Katja
• Zwanziger, Elke
• Potter, Julian
• Fraier, Daniela

Titel

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

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.