Here we describe a simple method that allows for rapid and easy sequence determination of cyclic peptoids. The key idea in this strategy is a post-screening "ring-opening" reaction to convert cyclic peptoids selected from a high-throughput screen into linear peptoids, which can be sequenced by tandem mass spectrometry. Thus, there is no need for encoding.
Objectives
Prednisone is a widely used anti-inflammatory for a variety of conditions. While oral liquid formulations of prednisone enable weight-based dosing, children frequently find them to be objectionable due to bitter taste. This limitation of prednisone can adversely impact patient acceptance and may result in non-compliance. Efforts to mask flavors often result in poorly controlled, heterogeneous particle distributions and can provide ineffective taste masking. The present work utilized a novel drug delivery technology developed by Orbis Biosciences, Inc., to create an oral taste-masked formulation of prednisone.
Methods
The study examined the palatability of Orbis’ microsphere prednisone formulation in healthy young adults (n=24). Four test articles were used in the study including a reference formulation (Roxane Laboratories), a control, and the test formulation (Orbis) prepared in two different ways. Study participants were randomized in a crossover design.
Key Findings
Results indicated that the test prednisone formulation was indistinguishable from the control, and both were preferable to the reference formulation in every category of palatability assessed using a validated 9-point Hedonic Scale. The data also suggested that preparing the microsphere suspension immediately prior to administration results in the most ideal palatability properties.
Conclusions
In conclusion, the novel microsphere formulation technology was effective in taste-masking prednisone.
The current standard of practice for use of clinical biomarkers is to set a dichotomous cutoff on a continuous variable to distinguish between "positive" or "negative" results. As the majority of infection biomarker tests are fundamentally quantitative, the practice of assigning a cutoff discards a significant amount of information that could contribute to improved diagnostic utility.
METHODS:We developed a new method to calculate precise post-test probabilities directly from experimental data and then applied the method to patient data sets. The data of interest included measures of C-reactive protein (CRP), procalcitonin (PCT), and nasopharyngeal lytA gene PCR (lytA) along with the gold standard etiologic criteria for patients.
RESULTS:We found that any dichotomous cutoff was essentially arbitrary, as a large range of values serve similarly well as cutoffs. We then computed post-test probabilities for every possible biomarker value. We found that our method provided more accurate post-test probability estimates than any optimal dichotomous cutoff. In addition, we found that our method allowed computing the probability of various categories of outcome variables: for example, the probability of Gram positive or Gram negative, or the probability of a specific bacterium. CONCLUSIONS: Using the described method in clinical practice is a cheap and easy means of calculating exact post-test probabilities for a range of important possible outcomes. This approach avoids dichotomous cutoffs and thereby avoids discarding valuable quantitative information.CLINICAL IMPLICATIONS: Our findings suggest dichotomous cutoffs limit the value of biomarker data, and that data obtained from a number of tests can be better analyzed to guide diagnosis and clinical decision making.
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