منابع مشابه
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"
متن کاملIncurred sample reproducibility and stability assessment in a cell-based drug concentration assay.
Joleen White is Principal Scientist in Translational Sciences at Biogen Idec. Throughout her career, she has applied her background in biophysical protein chemistry to pharmaceutical development in therapeutic indications with significant unmet medical need. In her current role, she supports method development and regulated bioanalysis of biomarkers, biopharmaceuticals, and immunogenicity in bi...
متن کاملIncurred sample stability of ASP3258 in the presence of its acyl glucuronide
The acyl glucuronide (AG) of ASP3258 was abundant in incurred monkey samples, and because an AG generally back-converts to its aglycone, accurate quantification of ASP3258 in monkey plasma was a challenge. To prevent the back-conversion of ASP3258-AG, cooling and acidification were incorporated during sample collection, storage, and extraction. To demonstrate that the AG did not affect the dete...
متن کاملConjoint Prediction of Paid and Incurred Losses
Actuaries use paid and incurred methods to predict losses. Then one method is selected, and usually the information contained in the other(s) is jettisoned. Sometimes methods are weighted together, but without statistical justification. And even when an incurred method is deemed sufficient, present valuing will require predictions of loss payments. This paper will present a statistical model wh...
متن کاملSpinal Cord Injury Incurred by Neck Massage
Massage is generally accepted as a safe and a widely used modality for various conditions, such as pain, lymphedema, and facial palsy. However, several complications, some with devastating results, have been reported. We introduce a case of a 43-year-old man who suffered from tetraplegia after a neck massage. Imaging studies revealed compressive myelopathy at the C6 level, ossification of the p...
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ژورنال
عنوان ژورنال: Bioanalysis
سال: 2011
ISSN: 1757-6180,1757-6199
DOI: 10.4155/bio.11.69