United States Pharmacopeia
  • Rockville, United States
Recent publications
HIV-prevention efforts focusing on women of child-bearing potential are needed to end the HIV epidemic in the African region. The use of antiretroviral drugs as pre-exposure prophylaxis (PrEP) is a critical HIV prevention tool. However, safety data on new antiretrovirals during pregnancy are often limited because pregnant people are excluded from drug development studies. Calls from communities, healthcare professionals, and regulators to improve the information supporting decision-making around the use of medical products during pregnancy have been increasing. Post-marketing safety surveillance is an essential tool for detecting adverse outcomes and evaluating real-world, longer-term effects of drugs. Detecting and evaluating uncommon pregnancy outcomes requires large sample sizes, highlighting the benefits of and need for safety surveillance. Surveillance systems vary widely across Africa, and the need for enhanced surveillance of PrEP use during pregnancy highlights the limitations of current regulatory and surveillance systems. Challenges include weak regulation and insufficient resources. Pooling of resources and regulatory harmonization could address resource challenges. The African Medicines Agency, as a specialized agency of the African Union, has the potential to improve African medical product regulation, including post-marketing safety surveillance. This can strengthen regulation and ensure that market authorization holders meet their responsibility to invest in post-marketing surveillance systems, such as pregnancy registries. At the same time, independent post-marketing studies are needed to ensure generation of essential safety data. The Forum for Collaborative Research has initiated a project to facilitate interactions between regulators in Africa, the USA, and Europe, as well as other stakeholders, and to work toward consensus on safety data generation from PrEP during pregnancy before and after marketing authorization.
Recombinant adeno-associated virus (AAV) is one of the main viral vector-based gene therapy platforms. AAV is a virus consisting of a ≈25 nm diameter capsid with a ≈4.7 kb cargo capacity. Therapeutic safety and efficacy depend on the correct encapsidation of the DNA in individual virus particles, which is often characterized by the single scalar value of the ratio of full capsids with complete viral genomes to the total viral capsid number [the full-to-total (FTT) ratio]. This study reports on the interlaboratory and intertechnique variations of measurement methods for FTT among a cohort of organizations. The analytical methods used were sedimentation velocity analytical ultracentrifugation (SV-AUC) with UV/Vis and/or Rayleigh interference optics, size exclusion chromatography (SEC) with multi-angle light scattering (MALS), and tandem UV/Vis and/or refractive index, cryogenic electron microscopy, dual-wavelength ultraviolet spectrophotometry, and ELISA coupled with quantitative PCR (qPCR, dPCR, or ddPCR). FTT measurements for both AAV5 and AAV8 serotypes were similar, except for PCR-ELISA. The optical techniques (UV spectroscopy/SEC-MALS) showed <10% SD between laboratories, likely from the uniformity of existing industry protocols. AUC, while demonstrating good repeatability, had ≈25% SD interlaboratory, suggesting the need for standardized methods. PCR and ELISA had poor reproducibility due to variations in both PCR and ELISA protocols and instrumentation. The discussion presents intended future efforts to improve and harmonize these measurements to increase both the repeatability and reproducibility of AAV viral particle critical quality attributes such as FTT.
The aim of this review was to update knowledge about the prevalence of periodontitis in Latin America and the Caribbean. A critical review of was performed of all cross-sectional or cohort studies selected, pertaining to the region, and thirty-five studies conducted in 12 countries were selected. The countries with nationally representative studies were Brazil, Chile, Colombia, and Uruguay. The prevalence of periodontal disease or need for periodontal treatment varied between the different studies and countries depending on the age group, the methodology used, and the case definition. The prevalence of severe periodontitis aged between 5.8% and 49.7% in adults. In adolescents, the prevalence of moderate to severe periodontitis was 15.3%. Furthermore, a high prevalence of gingival bleeding in adolescents was reported. When analyzing the studies that used the Community Periodontal Index (CPI), Centers for Diseases Control and American Academy Periodontology (CDC/AAP) case definition, it was observed that as the age of the individuals analyzed increased, the prevalence of periodontal disease also increased. Whereas this rereview revealed that although the number of regional and nationally representative studies that analyzed the prevalence of periodontitis has risen in recent years, their methodological heterogeneity prevents global conclusions to be drawn concerning the region. Therefore, this ratifies the need to generate alliances between countries with the purpose of joining individual efforts to achieve collective goals which, among other objectives, will translate into conducting multicenter studies. These studies would allow description and monitoring of the epidemiological behavior of periodontitis in Latin America and the Caribbean.
The aim of this study was to develop a mixture of dimethacrylate isomers (PG6EMA) as a potential monomer for dental adhesives and composites. PG6EMA was synthesized de novo and characterized in the presence of ethanol (3%, 6% or 9%). BisGMA/TEGDMA (BTEG, 50/50 wt.%) was used as the resin control. Composites were formulated with 60 wt.% of either PG6EMA or BisGMA (40 wt.% TEGDMA and 70 wt.% filler). DMPA (0.2 wt.%) and DPI-PF6 (0.4 wt.%) were added as photoinitiators, irradiated with a mercury arc lamp (320–500 nm, 500 mW/cm²; Acticure). All materials were tested for polymerization kinetics (near-infrared), viscosity (η) and storage modulus (G’, oscillatory rheometry). The composites were further characterized for water sorption/solubility, wet/dry flexural strength/modulus and polymerization stress. Data were analyzed with one-way ANOVA/Tukey’s test (α = 0.05). The PG6EMA resins showed lower rates of polymerization compared with BTEG (p = 0.001) but high degrees of conversion (p = 0.002). Solvent concentration did not affect RPMAX but the 6% and 9% mixtures showed higher final DC, likely due to reduced viscosity. PG6EMA had much higher viscosity than BTEG (p <0.001) and lower G’ (p = 0.003). Composites modified with PG6EMA have slower polymerization rates (p = 0.001) but higher final DC (p = 0.04) than the control. PG6EMA/TEGDMA showed lower dry/wet flexural strength and comparable dry modulus. The PG6EMA/TEGDMA composite showed a 18.4% polymerization stress reduction compared to the BTEG composite. Both base monomers had similar WS/SL and G’. Within its limitations, this study demonstrated that the newly synthesized PG6EMA was a viable alternative to BisGMA in dental composites.
Advanced bioinformatics analysis, such as systems biology (SysBio) and artificial intelligence (AI) approaches, including machine learning (ML) and deep learning (DL), is increasingly present in stem cell (SC) research. An approximate timeline on these developments and their global impact is still lacking. We conducted a scoping review on the contribution of SysBio and AI analysis to SC research and therapy development based on literature published in PubMed between 2000 and 2024. We identified an 8-10-fold increase in research output related to all three search terms between 2000 and 2021, with a 10-fold increase in AI-related production since 2010. Use of SysBio and AI still predominates in preclinical basic research with increasing use in clinically oriented translational medicine since 2010. SysBio- and AI-related research was found all over the globe, with SysBio output led by the United States (US, n=1487), United Kingdom (UK, n=1094), Germany (n=355), The Netherlands (n=339), Russia (n=215), and France (n=149), while for AI-related research the US (n=853) and UK (n=258) take a strong lead, followed by Switzerland (n=69), The Netherlands (n=37), and Germany (n=19). The US and UK are most active in SCs publications related to AI/ML and AI/DL. The prominent use of SysBio in ESC research was recently overtaken by prominent use of AI in iPSC and MSC research. This study reveals the global evolution and growing intersection between AI, SysBio, and SC research over the past two decades, with substantial growth in all three fields and exponential increases in AI-related research in the past decade.
This paper investigates the effectiveness of various metrics for selecting the adequate model for binary classification when data is imbalanced. Through an extensive simulation study involving 12 commonly used metrics of classification, our findings indicate that the Matthews Correlation Coefficient, G-Mean, and Cohen’s kappa consistently yield favorable performance. Conversely, the area under the curve and Accuracy metrics demonstrate poor performance across all studied scenarios, while other seven metrics exhibit varying degrees of effectiveness in specific scenarios. Furthermore, we discuss a practical application in the financial area, which confirms the robust performance of these metrics in facilitating model selection among alternative link functions.
In a time of environmental calamities, pandemics, and social inequality, the development of people to deal with complex situations and solve threats to the planet's sustainability becomes relevant. In this context, Higher Education Institutions (HEIs) play an important role, as they are instruments for developing competencies for sustainability (DCS). However, how to move forward to this purpose remains a gap in the literature. To address this issue, the present research aims to develop and validate a model for DCS to HEIs. A systematic literature review gathered 271 articles on DCS and HEIs, which were systematized, categorized, and analyzed. The analysis resulted in the Model “Development of Competencies for Sustainability in Higher Education Institutions” (DCS-IES) validated through interviews with 30 experts. The proposed model represents the first model for creating an integrated program focused on the institutionalization and development of CS at universities besides incorporating different audiences of HR from HEIs, such as professors and staff. Another research contribution focuses on the model's potential to promote programs and institutional politics at HEIs and to favor government planning and the design of public policies and practices.
The integration of physical and cybernetic systems introduces new functionalities that modify the configuration of autonomous driving vehicles. The vehicle's driving behavior is subject to respond differently than the driver expects, causing accidents. Innovation in cybernetic systems is based on still immature information. To achieve socially responsible innovation, it is necessary to dispel the uncertainties of the black box of new technologies. We use an argumentative method to show that there is a pattern, a unique structure, that appears repeatedly in the cognitive linguistic process of both human beings and intelligent systems. From this, we aim not only show that this pattern guarantees coherence to the decision-making performed by cognitive computing, but also that it reveals what is at stake in the intelligence of autonomous cars and in the biases of the black box of AI. Therefore, by clarifying the dynamic of the unique cognitive linguistic process, as a common process for individuals and machines, it is possible to manage the interpretive activity of cyber-physical systems and the way they decide, providing safe and sustainable autonomous cars.
Concerns about health hazards associated with the consumption of trans-delta-8-tetrahydrocannabinol products were highlighted in public health advisories from the U. S. Food and Drug Administration and U. S. Centers for Disease Control and Prevention. Simple and rapid quantitative methods to determine trans-delta-8-tetrahydrocannabinol impurities are vital to analyze such products. In this study, a gas chromatography-flame ionization detection method was developed and validated for the determination of delta-8-tetrahydrocannabinol and some of its impurities (recently published) found in synthesized trans-delta-8-tetrahydrocannabinol raw material and included olivetol, cannabicitran, Δ ⁸-cis-iso-tetrahydrocannabinol, Δ ⁴-iso-tetrahydrocannabinol, iso-tetrahydrocannabifuran, cannabidiol, Δ 4,8-iso-tetrahydrocannabinol, Δ ⁸-iso-tetrahydrocannabinol, 4,8-epoxy-iso-tetrahydrocannabinol, trans-Δ ⁹-tetrahydrocannabinol, 8-hydroxy-iso-THC, 9α-hydroxyhexahydrocannabinol, and 9β-hydroxyhexahydrocannabinol. Validation of the method was assessed according to the International Council for Harmonization guidelines and confirmed linearity with R² ≥ 0.99 for all the target analytes. The limit of detection and limit of quantitation were 1.5 and 5 µg/mL, respectively, except for olivetol, which had a limit of detection of 3 µg/mL and a limit of quantitation of 10 µg/mL. Method precision was calculated as % relative standard deviation and the values were less than 8.4 and 9.9% for the intraday precision and inter-day precision, respectively. The accuracy ranged from 85 to 118%. The method was then applied to the analysis of 21 commercially marketed vaping products claiming to contain delta-8-tetrahydrocannabinol. The products analyzed by this method have various levels of these impurities, with all products far exceeding the 0.3% of trans-Δ ⁹-tetrahydrocannabinol limit for hemp under the Agriculture Improvement Act of 2018. The developed gas chromatography-flame ionization detection method can be an important tool for monitoring delta-8-tetrahydrocannabinol impurities in commercial products.
Maca (Lepidium meyenii), a biennial herbaceous plant indigenous to the Andes Mountains, has a rich history of traditional use for its purported health benefits. Maca’s chemical composition varies due to ecotypes, growth conditions, and post-harvest processing, contributing to its intricate phytochemical profile, including, macamides, macaenes, and glucosinolates, among other components. This review provides an in-depth revision and analysis of Maca’s diverse bioactive metabolites, focusing on the pharmacological properties registered in pre-clinical and clinical studies. Maca is generally safe, with rare adverse effects, supported by preclinical studies revealing low toxicity and good human tolerance. Preclinical investigations highlight the benefits attributed to Maca compounds, including neuroprotection, anti-inflammatory properties, immunoregulation, and antioxidant effects. Maca has also shown potential for enhancing fertility, combating fatigue, and exhibiting potential antitumor properties. Maca’s versatility extends to metabolic regulation, gastrointestinal health, cardio protection, antihypertensive activity, photoprotection, muscle growth, hepatoprotection, proangiogenic effects, antithrombotic properties, and antiallergic activity. Clinical studies, primarily focused on sexual health, indicate improved sexual desire, erectile function, and subjective wellbeing in men. Maca also shows promise in alleviating menopausal symptoms in women and enhancing physical performance. Further research is essential to uncover the mechanisms and clinical applications of Maca’s unique bioactive metabolites, solidifying its place as a subject of growing scientific interest.
The United States Pharmacopeia (USP) is an independent, nonprofit science-based organization whose mission is to improve global health through public standards and related products for medicines, food and dietary supplements. Probiotic-based dietary supplements are increasingly popular in the marketplace and USP has developed fourteen monographs specific to probiotic ingredients, including representatives from the Genera Lactobacillus, Bacillus, Streptococcus, and Bifidobacterium. These monographs include the definition of the article, tests for identification, quantification assays (enumeration in the case of probiotics), limits for contaminants, and other quality parameters when appropriate. In addition to quality, the USP also considers the safety of probiotics for monograph development. This report includes an overview of the USP admission evaluation process for probiotics as well as a tabular summary of the probiotic monographs currently available. Pharmacopeia monographs can guide manufacturers and brand owners and protect consumers through establishment of quality standards.
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20 members
Sean P. Delaney
  • Excipients
Mark Verdecia
  • Global Biologics
Ryan Crawford
  • Biologics and Biotechnology
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