The authors assess the equivalence of 2 assays and put forward a general approach for assay agreement analysis that can be applied during drug discovery. Data sets generated by different assays are routinely compared to each other during the process of drug discovery. For a given target, the assays used for high-throughput screening and structure-activity relationship studies will most likely differ in their assay reagents, assay conditions, and/or detection technology, which makes the interpretation of data between assays difficult, particularly as most assays are used to measure quantitative changes in compound potency against the target. To better quantify the relationship of data sets from different assays for the same target, the authors evaluated the agreement between results generated by 2 different assays that measure the activity of compounds against the same protein, ALK5. The authors show that the agreement between data sets can be quantified using correlation and Bland-Altman plots, and the precision of the assays can be used to define the expectations of agreement between 2 assays. They propose a scheme for addressing issues of assay data equivalence, which can be applied to address questions of how data sets compare during the lead identification and lead optimization processes in which assays are frequently added and changed. (Journal of Biomolecular Screening 2005:508-516)
Background:Management of diabetes mellitus (DM) remains a challenge in the US, as almost half of patients with diabetes are uncontrolled with a hemoglobin A1c (HbA1c) >7%. Over the last decade there has been increasing evidence supporting the integration of Clinical Pharmacy Specialists (CPSs) to multidisciplinary medical teams which have demonstrated improved glycemic control and better clinical outcomes in the primary care setting.Objectives:The primary objective of this study was to evaluate the change in HbA1c levels in patients with diabetes followed by a CPS. The secondary objectives of this study were to evaluate the percent of patients who reached American Diabetes Association (ADA) goal HbA1c (<7%) by study conclusion and evaluate documentation of hypoglycemic events in progress notes.Methods:A retrospective chart review evaluating glycemic control was conducted on patients with DM managed by a CPS at a large Veterans Affairs Medical Center. Patients with a diagnosis of Type 1 or Type 2 DM with a baseline HbA1c ≥9% and at least three CPS visits over twelve months were included in this study. Patients with cognitive impairment as documented by ICD-9 codes or with less than three CPS visits over twelve months were excluded.Results:A sample of 79 patients was identified. The mean HbA1c declined by 1.5 percentage points (from 10.6%, SD=1.4 to 9.1%, SD=1.5) after one year. No patients reached ADA goal of HbA1c <7% at study conclusion, however 23% of patients reached a less stringent goal of <8%. All CPS progress notes assessed episodes of hypoglycemia and provided education, and no hospitalizations were related to hypoglycemic events.Conclusions:Integration of a CPS into a veteran’s diabetes care was associated with improved outcomes and enhanced hypoglycemic education. Our results advance the existing literature by demonstrating a positive association between CPS intervention and improved glycemic control in a complex veteran population.
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