Mohrhaslund7829

Data are examined regarding possible waiver of in vivo bioequivalence testing (i.e. biowaiver) for approval of metformin hydrochloride (metformin) immediate-release solid oral dosage forms. Data include metformin's Biopharmaceutics Classification System (BCS) properties, including potential excipient interactions. Metformin is a prototypical transporter-mediated drug and is highly soluble, but only 50% of an orally administered dose is absorbed from the gut. Therefore, metformin is a BCS Class III substance. A BCS-based approval approach for major changes to marketed products and new generics is admissible if test and reference dosage forms have the identical active pharmaceutical ingredient and if in vitro dissolution from both are very rapid (i.e. at least 85% within 15 min at pH 1.2, 4.5, and 6.8). Recent International Council for Harmonisation BCS guidance indicates all excipients for Class III biowaivers are recommended to be qualitatively the same and quantitatively similar (except for preservatives, flavor agents, colorant, or capsule shell or film coating excipients). However, despite metformin being a prototypical transporter-mediated drug, there is no evidence that commonly used excipients impact metformin absorption, such that this restriction on excipients for BCS III drugs merits regulatory relief. Commonly used excipients in usual amounts are not likely to impact metformin absorption.The aim of this study was to evaluate the toxicological profile of biosurfactant encapsulated polymeric nanoparticles of Polylactic acid-Polyethylene glycol (PLA-PEG) in mice. Hematological, biochemical and histopathological samples of rodents were evaluated. Mice were selected randomly and divided into 3 treatment groups and one control group. Group I mice served as a control group, Group II were administrated with biosurfactant, Group III were treated with Polymeric nanoparticles of PLA-PEG. Group IV mice were injected with biosurfactant loaded polymeric nanoparticles of PLA-PEG. The formulations were administered intravenously via tail vein with 20 μg/mL dose concentration of biosurfactant. Hedgehog inhibitor The normal control group was injected with only PBS. Blood samples were collected on 7th, 14th and 21st day and hematological and biochemical assays were performed. After the blood collection, mice were sacrificed for histopathological examination. The results showed that there were no significant difference in hematology parameter between the control and treated group. Some minute, non-significant changes were found in biochemical parameters which were not considered. Histopathological result of selected vital organs revealed that the biosurfactant and/or PLA-PEG polymeric nanoparticles can be considered as safe as no toxicological features were observed in histopathology of tissues. Hence, it can be deliberated that the biosurfactant encapsulated in PLA-PEG copolymeric nanoparticles are non toxic and can provide a safe, suitable platform for biomedical applications in future.Clinicians supporting patients in lifestyle behavior change is an important strategy to help reduce chronic disease burden. Using National Health and Nutrition Examination Survey (NHANES) data from 2015 to 2018, this study assessed rates of and associations between patient-reported receipt of lifestyle behavior change advice and corresponding self-reported behavior change for four different lifestyle behaviors 1) weight loss, 2) increase physical activity, 3) reduce sodium, and 4) reduce fat and calories. Adult survey respondents with hypertension and/or diabetes (n = 4716) who received lifestyle advice ranged from 43% to 58%, with the most common recommendation being to increase physical activity. Between 61% and 73% of respondents reported currently modifying health behaviors, with the greatest number reporting weight loss. Multiple logistic regression models were used to test associations for each lifestyle behavior advice-behavior change pair, adjusting for demographic characteristics. Compared to those who received no advice, respondents who received advice had significantly higher odds of reporting losing weight (aOR 1.93; 95% CI 1.51, 2.48); increasing physical activity (aOR 2.02; 95% CI 1.73, 2.37); reducing dietary sodium (aOR 4.95; 95% CI 3.93, 6.25); and reducing intake of fat/cal (aOR 3.57; 95% CI 2.86, 4.45). This study utilized population level data to lend further evidence that provider advice about lifestyle behaviors for patients who have hypertension or diabetes may influence patient behavior. However, prevalence of advice is low, and differences in rates of behavior change exist across socioeconomic status and race/ethnicity, indicating a need to further research how providers might better support patients with varying social needs.Procalcitonin (PCT) is an important biomarker for sepsis diagnosis and management. To date, there is no higher-order reference measurement procedure (RMP) and certified reference material to achieve global standardization of results and results traceability to the SI units. Although efforts have been made to harmonize PCT results, a number of comparison studies and external quality assessment (EQA) schemes show conflicting results regarding results comparability and to date, equivalence of PCT results across the assays remains questionable in absence of studies relying on commutable EQA materials. In this context, the IFCC initiated activities to fill these gaps through the creation of the working group on standardization of PCT assays that gathers experts from National Metrology Institutes, calibration laboratories, clinicians, biologists, EQA providers and assay manufacturers. Among the activities, a higher order RMP and commutable reference materials are under development to build a robust reference measurement system (RMS). A commutability study is being organized to identify EQA materials that are fit for purpose to reliably estimate the current comparability of PCT results. This work will make it possible to evaluate the necessity and the feasibility for establishing and maintaining a new RMS for PCT assays, if deemed necessary.