Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10143271 | Contemporary Clinical Trials Communications | 2018 | 8 Pages |
Abstract
The concept of the presented feasibility study that simultaneously assesses PK/PD sampling, sample preparation, logistics and bioanalysis proved to be a promising tool for trial preparation. It revealed improperly installed processes and bottlenecks that required adjustments prior to start of recruitment. It facilitated high-quality conduct from the first moment of paediatric pivotal studies.
Keywords
CmaxPercentage pointsEMAACEFDARIAGCPLC-MS/MSAngiotensin-converting-enzymeEuropean Medicines agencyEuropean UnionU.S. Food and Drug AdministrationFeasibilityELISAEnzyme-linked immunosorbent assaymaximum serum concentrationPilotradioimmunoassayRenin-angiotensin-aldosterone systemLiquid chromatography-tandem mass spectrometrygood clinical practicepharmacodynamicpharmacokineticPharmacokinetic(s)LENAClinical trial
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Authors
Agnes Maria Ciplea, Stephanie Laeer, Bjoern Bengt Burckhardt,