High Point University
  • High Point, NC, United States
Recent publications
The United States Food and Drug Administration (USFDA) demands that the generic industry prove topical ocular products' pharmaceutical and bioequivalence (BE). In contrast to generic oral drugs, topical ocular product BE testing has proved difficult. New generic versions are compared to an authorized drug product known as a Reference Listed Drug (RLD) to demonstrate their bioequivalence. If the excellent in-vitro results may support the presumption of equivalence in-vivo performance and the only clinically significant difference between the generic and RLD is in its physicochemical qualities and drug release rate, then in-vivo BE studies may be waived. Proving BE through dissolution tests is a golden standard for most conventional dosage forms. However, due to the limited number of biorelevant in-vitro drug release testing (IVRT) approaches capable of differentiating their performance based on product quality and physicochemical properties, the development of generic ophthalmic products has been slow and time-consuming. Often, BE of topical ophthalmic formulations cannot be proved using a single in-vitro test; therefore, an elaborated discussion on various IVRT methods performed to demonstrate bioequivalence of complex generis like ophthalmic emulsions, suspensions, ointments, and gels is necessary. This manuscript aims to review the status of biowaiver criteria for complex ophthalmic products concerning the product-specific FDA guidance to the generic industry.
Purpose Investigate the impact of sex, menstrual cycle phase and oral contraceptive use on intestinal permeability and ex-vivo tumour necrosis factor alpha (TNFα) release following treatment with lipopolysaccharide (LPS) and hyperthermia. Methods Twenty-seven participants (9 men, 9 eumenorrheic women (MC) and 9 women taking an oral contraceptive pill (OC)) completed three trials. Men were tested on 3 occasions over 6 weeks; MC during early-follicular, ovulation, and mid-luteal phases; OC during the pill and pill-free phase. Intestinal permeability was assessed following a 4-hour dual sugar absorption test (lactulose: rhamnose). Venous blood was collected each trial and stimulated with 100 μg·mL⁻¹ LPS before incubation at 37 °C and 40 °C and analysed for TNFα via ELISA. Results L:R ratio was higher in OC than MC (+0.003, p = 0.061) and men (+0.005, p = 0.007). Men had higher TNFα responses than both MC (+53 %, p = 0.004) and OC (+61 %, p = 0.003). TNFα release was greater at 40 °C than 37 °C (+23 %, p < 0.001). Conclusions Men present with lower resting intestinal barrier permeability relative to women regardless of OC use and displayed greater monocyte TNFα release following whole blood treatment with LPS and hyperthermia. Oral contraceptive users had highest intestinal permeability however, neither permeability or TNFα release were impacted by the pill cycle. Although no statistical effect was seen in the menstrual cycle, intestinal permeability and TNFα release were more variable across the phases.
Temporomandibular (TM) disorders afflict many people globally and, despite the presence of existing peer-reviewed material that assists conservative orthopedic providers, recent advances in knowledge indicate that updated resources are required for students, clinicians, and educators. This two-part series builds off previously published material to present newer supplementary information that can be useful during the evaluation and management processes. Content in Part 1 of this series includes a discussion about the factors that have been shown to contribute to TM disorders, an updated perspective of relevant pain science, a discussion of self-report outcome measures, and various different topics related to the examination of patients with TM disorders. Part 2 addresses information related to the temporomandibular joint disc, joint hypermobility, oral splints, and clinical reasoning. In combination with other available publications, this two-part series provides clinicians an opportunity to improve their delivery of effective and efficient clinical services for people diagnosed with TM disorders.
Increasing politicization of health guidance and fluctuating trust in public health institutions have challenged effective coronavirus disease 2019 (COVID-19) public health communication in the United States. Applying the extended parallel process model, this research reports findings from two online survey experiments conducted at different points in the pandemic regarding two advocated risk reduction behaviors. Analyses test US adults’ emotional and argument strength reactions to experimental tweets attributed to the Centers for Disease Control (CDC) and Prevention which vary with regards to advocated behavior (social distancing; vaccination), emotional appeal, wellbeing orientation (individual vs. collective), and content frame (health vs. economic outcomes). Trust in the CDC is treated as a potential moderator. Results of path analyses indicated that emotional appeal and content frame had little impact on emotional or cognitive responses to the social distancing tweets, though unvaccinated adults with low trust in the CDC experienced greater hope and fear responses to tweets emphasizing collective benefits of vaccination. Hope reactions in both studies predicted greater perceived response efficacy for the advocated behavior, particularly among those with low CDC trust, while message annoyance undermined efficacy among low trust participants. Particularly among adults with low trust in the CDC, fear reactions led to reduced efficacy. Perceived efficacy of vaccination predicted greater intention to receive a COVID-19 vaccine, controlling for prior intention. Messages which inspire hope with regards to risk reduction behaviors and include sound arguments may be more motivating than fear-appeal messages, particularly among individuals with low levels of trust in public health institutions.
This article describes the design, implementation, and evaluation of five faculty development sessions focused on inclusive teaching strategies in pharmacy education. Inclusive strategies ensure that every student can clearly understand and engage in meaningful learning opportunities. Three sessions were implemented in fall 2020 and two in spring 2021. Sessions focused on experiential, didactic, and graduate education. A convergent parallel mixed methods evaluation was conducted using descriptive statistics and thematic analysis. Sessions were highly rated, and participants provided suggestions for curriculum improvement (e.g., creating resources, surveying students, and peer auditing syllabi for aspects of inclusiveness). Given the increasing emphasis on inclusion in pharmacy education, this work is timely for sharing strategies aimed at faculty development and teaching practices.
Clostridioides difficile infection (CDI) disproportionately affects certain populations, but few studies have investigated health outcome disparities among patients with CDI. This study aimed to characterize CDI treatment and health outcomes among patients by age group, sex, race, and ethnicity. This was a nationally representative, retrospective cohort study of patients with laboratory-confirmed CDI within the Premier Healthcare Database from January 2018 to March 2021. CDI therapies received and health outcomes were compared between patients by age group, sex, race, and Hispanic ethnicity using bivariable and multivariable statistical analyses. A total of 45,331 CDI encounters were included for analysis: 38,764 index encounters and 6567 recurrent encounters. CDI treatment patterns, especially oral vancomycin use, varied predominantly by age group. Older adult (65+ years), male, Black, and Hispanic patients incurred the highest treatment-related costs and were at greatest risk for severe CDI. Male sex was an independent predictor of in-hospital mortality (aOR 1.17, 95% CI 1.05–1.31). Male sex (aOR 1.25, 95% CI 1.18–1.32) and Black race (aOR 1.29, 95% CI 1.19–1.41) were independent predictors of hospital length of stay >7 days in index encounters. In this nationally representative study, CDI treatment and outcome disparities were noted by age group, sex, and race.
Branched‐chain amino acids (BCAA) are essential in the diet and promote several vital cell responses which may have benefits for health and athletic performance, as well as disease prevention. While BCAA are well‐known for their ability to stimulate muscle protein synthesis, their effects on cell energetics are also becoming well‐documented, but these receive less attention. In this review, we highlight much of the current evidence demonstrating BCAA ability (as individual amino acids or as part of dietary mixtures) to alter regulators of cellular energetics with an emphasis on mitochondrial biogenesis and related signaling. Several studies have shown, both in vitro and in vivo, that BCAA (either individual or as a mixture) may promote signaling associated with increased mitochondrial biogenesis including the upregulation of master regulator of mitochondrial biogenesis peroxisome proliferator‐activated receptor gamma coactivator 1‐alpha (PGC‐1α), as well as numerous downstream targets and related function. However, sparse data in humans and the difficulty of controlling variables associated with feeding studies leaves the physiological relevance of these findings unclear. Future well‐controlled diet studies will be needed to assess if BCAA consumption is associated with increased mitochondrial biogenesis and improved metabolic outcomes in healthy and/or diseased human populations. This article is protected by copyright. All rights reserved
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926 members
Michael J Oudshoorn
  • School of Enginering
Scott E Hemby
  • Fred Wilson School of Pharmacy
James M Smoliga
  • School of Health Sciences
Nicole M Hughes
  • Department of Biology
Jeffrey Taylor
  • School of Health Sciences
833 Montlieu Avenue, 27262, High Point, NC, United States
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