Biology subjects

Lodder, R. A.

Publications and source records attributed to Lodder, R. A..

3 recordsLinked to original sources

bioRxiv2018

Characterization of BSN175: A Drug to Treat Prader-Willi Syndrome

The purpose of this research is to choose the best analytical method for determining stability of BSN175. This research uses an accelerated stability study to compare the decomposed and stable drug using IR and 1H NMR spectroscopy. The Bootstrap Error-adjusted Single-sample Technique (BEST) was used to compare the effectiveness of these analytical methods and choose the best option for determining stability.

pharmacology and toxicology↗

bioRxiv2018

Setting Starting Level for a Trial of an Biofilm-Disrupting Adjuvant

Combination therapy is beneficial treatment modality for multiple diseases. Cinnamon oil may be an advantageous agent in a number of combination therapies as cinnamon oil has antibacterial activity. Cinnamon oil has also been shown to be effective against biofilm cultures of Streptococcus mutans and Lactobacillus plantarum. Cinnamomum osmophloeum inhibits planktonic cultures of many gram-positive and gram-negative bacteria, including MRSA (methicillin-resistant Staphylococcus aureus). Subjecting S. epidermidis to cinnamon oil eliminates planktonic cells or staphylococci in biofilms. Cinnamon oil is an essential oil used throughout the food industry because of its pleasant and distinctive aroma. The purpose of this study is to estimate the amount of exposure to cinnamon through selected foods in the United States in order to propose an initial target level for pharmacokinetic studies of a novel combination drug.

pharmacology and toxicology↗

bioRxiv2018

The QNOAEL vs. BMD for Point of Departure

Quantile bootstrap (QB) methods can be applied to the problem of estimating the No Observed Adverse Effect Level (NOAEL) of a New Molecular Entity (NME) to anticipate a safe starting dose for beginning clinical trials. An estimate of the NOAEL from the extended QB method (called the QNOAEL) can be calculated using multiple disparate studies in the literature and/or from laboratory experiments. The QNOAEL is similar in some ways to the Benchmark Dose (BMD) and is superior to the BMD in others. The Benchmark Dose method is currently widely used in toxicological research.\n\nResults are used in a simulation based on nonparametric cluster analysis methods to calculate confidence levels on the difference between the Effect and the No Effect studies. The QNOAEL simulation generates an intuitive curve that is comparable to the dose-response curve.\n\nThe QNOAEL of ellagic acid (EA) will be calculated for clinical trials of its use as a component therapeutic agent (in BSN476) for treating Chikungunya infections. This will be the first application of QB to the problem of NOAEL estimation for a drug. The specific aims of the proposed study are to evaluate the accuracy and precision of the QB Simulation and QNOAEL compared to the Benchmark Dose Method, and to calculate the QNOAEL of EA for BSN476 Drug Development.

pharmacology and toxicology↗