The Impact of the Packaging System on the Stability of Blood Samples Used for Safety Assessments in Clinical Trials

Rubrik: Originale

(Treffer aus pharmind, Nr. 02, Seite 284 (2017))

Obers A | Atemnkeng J | von Bühler B | Wnendt S

The Impact of the Packaging System on the Stability of Blood Samples Used for Safety Assessments in Clinical Trials / Obers et al. • Stability of Blood Samples · Obers A, Atemnkeng J, von Bühler B, Wnendt S · MLM Medical Labs GmbH, Mönchengladbach, Germany und
Clinical trials Sample logistics Thermal stress Central laboratory Safety parameters Accurate screening of potential study subjects for clinical trials and safety and efficacy assessments of drug candidates are well-known requirements by medicinal product authorities such as the European Medicines Agency and the U.S. Food and Drug Administration. The overall health of clinical trial participants and any physiological effects of the drug candidates are monitored through regular analyses of blood, serum and plasma samples, among other tests. The complete blood count (CBC) is used to test for a wide range of pathological conditions, including anemia, leukemia or erythropoietic disorders, when screening ...