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Analytical Method and Assay
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
While conceptually meaningful and relevant to ensure the future quality of analytical results, the AQbD paradigm poses several challenges from a statistical standpoint and requires a methodological shift from traditional statistical practices. Indeed, demonstrating robustness for the analytical results that will be provided tomorrow (e.g. during routine) implies the necessity to make predictions about the future quality given the past evidence and data. It appears that the framework of Bayesian statistics is particularly well-suited for this type of computation. Evaluating the predictive probability of success of jointly meeting each set of specifications of the ATP, given the assumed underlying model and high dependencies between measurements, is a challenge that may prove cumbersome or even impossible using the better-known frequentist statistics.
Biobanks in personalized medicine
Published in Expert Review of Precision Medicine and Drug Development, 2018
Kurt Zatloukal, Cornelia Stumptner, Penelope Kungl, Heimo Mueller
The in-depth analysis of workflows and procedures helps to reveal deviations from the requirements of standards and guidelines and shows where optimization measures are needed. However, the successful implementation of biospecimen quality standards or best practices in everyday medical and research practice poses several challenges. Many steps of the pre-analytical workflow occur in various independent institutions or departments. Some of them are performed by non-laboratory staff without supervision of a laboratory, pathology or biobank professional or by personnel that does not have profound understanding of how their actions may affect biospecimen quality and analytical results [49]. Particularly for hospital-integrated biobanks implementation is difficult when various departments are involved in biospecimen-related processes and different carrier organizations are responsible for patient care and biobanking. Finally, performing procedures according to the recommendations of standards, and the certification or accreditation of biobanks by authorized standardization bodies are both cost-intensive.
The association between hospital admission and substance use among trauma patients
Published in Journal of Substance Use, 2018
Therese Rye Eriksen, Linnea Shumba, Øivind Ekeberg, Stig Tore Bogstrand
It was a strength that the study site was at a hospital that is both a local hospital and a regional trauma center. This gave a more comprehensive overview of all injury types, considering that the hospital treats both major traumas and less severe injuries. A further strength of this study was that the data was collected over a 12-month period, avoiding seasonal variations in the sample of injuries. An accredited laboratory in forensic toxicology carried out the analyses of the blood samples and this supports the high quality of analytical results (Christophersen & Morland, 1997).