Quality Of Medicines Research Articles

Relationship between the root processing method and quality of herbal medicine of Rauvolfia serpentina cultivated in Japan

Rauvolfia serpentina roots are used as herbal medicine for snake and insect bites, fever, malaria, abdominal pain, hypertension, and dysentery in Southeast Asian countries. This study evaluates the content of reserpine, ajmaline, and ajmalicine in R. serpentina roots obtained with an efficient root processing method. The plants were cultivated in Tanegashima Island in southern part of Japan, where NIBIOHN's experimental farm station is located. We examined both the type of cork layer removal method (manual work, drum mixer washing, and high-pressure washing) and dried roots. We found that the resulting active ingredient contents were not significantly different between manual work and 30 min of drum mixer washing, and high-pressure washing. The washing in a drum mixer for 30 min could be an efficient root processing method. The amount of each active ingredient was compared in each root part (large-, middle-, and small-diameter roots), and there were no significant difference in their contents. In conclusion, R. serpentina roots having a diameter ≥ 0.5 cm contain a similar amount of active ingredients, suggesting that the quality of the crude drug does not vary in the root part. Thus, our study provides significant insights into the use of R. serpentina roots for herbal medicine applications as well as constituents of active ingredients.

Comparing the educational quality of YouTube and Facebook videos on tympanostomy tubes

PurposePatients often refer to online materials when researching surgical procedures. This study compares the educational quality of online videos about tympanostomy tubes on two popular video platforms: YouTube and Facebook. This study provides clinicians with context about the content and quality of information patients may possess after watching online videos on tympanostomy tubes. Materials and methodsYouTube and Facebook were searched using key terms related to tympanostomy tubes. Videos were screened and scored in triplicate. DISCERN quality, content, production, and alternative medicine scores were assigned. Statistical analysis was conducted using GraphPad Prism. Results76 YouTube and 86 Facebook videos were analyzed. DISCERN quality scores (mean = 1.8 vs. 1.4, P < .0001), content scores (mean = 1.7 vs. 1.0, P < .0001), and production scores (mean = 4.8 vs. 4.6, P = .0327) were significantly higher on YouTube compared to Facebook. 33 % of Facebook videos referenced alternative medicine, as compared with 0 % of YouTube videos (P < .0001). Physician/hospital-generated videos had significantly higher DISCERN and content scores than parent-, product-, and chiropractor-generated videos. Views did not correlate with DISCERN or content scores. ConclusionYouTube is a better platform than Facebook for educational videos about tympanostomy tubes. YouTube videos had higher educational quality, more comprehensive content, and less alternative medicine. One third of Facebook videos advocated for alternative treatments. Importantly, videos on both platforms were of limited educational quality as demonstrated through low DISCERN reliability scores and coverage of few important content areas.

A National Disaster Medicine Quality Management Tool in an International Context – A Theoretical Study

Abstract The impact of disasters is changing, with disaster events becoming more complex and often affecting multiple countries simultaneously. Despite this, quality management systems have not yet been established in the field of disaster medicine. The German research project QUARZ-SAND, developed a national disaster medicine quality management system and an online registry. This theoretical study ascertains the current state of quality management in disaster medicine and compares existing initiatives to QUARZ-SAND and highlights advantages and synergies in the pooling of incident data, in view of improving resilience to national and transboundary disaster events. A systematic literature research was conducted on December 18, 2020 in the databases PubMed and LIVIVO. Existing disaster medicine quality management tools were identified and compared with QUARZ-SAND. It was determined that a lot of effort is still needed to get to an internationally accepted common standard and a tool such as a registry for evaluating medical disaster responses. A first step toward the establishment of a registry is the development of a standardized data set.

Integrating traditional medicine into a modern health care system

Traditional Medicine collectively referred to as complementary and alternative medicine (CAM) when commonly used outside their traditional context, alongside other medical systems, including Western biomedicine.The World Health Organization officially promoted traditional medicine in developing countries in 1978, there have been increasing interests among developing countries in integrating traditional medicine into a national health care system. Integrating traditional medicine into a modern health care system, moreover, can benefit industrialized nations as well. The contributions of Traditional and Modern Scientific Medicines to health care delivery have attracted a great deal attention in most communities worldwide. Traditional Chinese medicine, Ayurveda, Kampo, traditional Korean medicine, and Unani have been practiced in some areas of the world and have blossomed into orderly-regulated systems of medicine. More than 80% of the world’s population in over 170 of WHO’s 194 Member States currently use some form of traditional medicine, such as herbal medicine, yoga, Ayurveda, acupuncture and acupressure, and indigenous therapies.To generate awareness about traditional medicine, since the 1980s, a number of publications on self-health care have been developed to inform people about the benefits and uses of traditional medicine. Some of the areas of focused research include studies on the development of anticancer drugs, cardiovascular diseases such as arteriosclerosis and angina pectoris, respiratory diseases such as bronchial asthma, obesity, diabetes and other metabolic disorders, and basic studies on acupuncture therapeutic mechanisms for various bone and joint and spinal disorders, and on different kinds of composition of the human body. To ensure the safety, standardization, efficacy and quality of traditional medicines, the practitioners must follow the same stringent standards and regulations for production and use of traditional medicines as are followed for allopathic medicines. This study aims to summarize the advancements made in understanding the efficacy, effectiveness of Traditional Medicine. Traditional and local knowledge systems need to be protected, preserved, and studied as different ways to approach modern healthcare, science, and technology at large. Significant challenges exist in integrating the differing perspectives. Traditional knowledge is derived from years of history and experience and is preserved through long, complex narrations lacking the traditionally rigorous scientific scrutiny required by modern medicine. Modern scientists are prone to quickly dismiss its merit, considering it to be irrelevant as a result. For many, traditional medicine is the first port of call, and practitioners of traditional medicine have played an important role in treating chronic illnesses. These traditional medicines and practices have been preserved, organized and modernized during the past several decades, and have been fully integrated into the national health-care delivery systems from the central to the most peripheral administrative levels.

Improving of vitamins C and D3 content of medicinal pumpkin plant grown under organic farming programs

This study aimed to evaluate the application of different farming programs. Three organic farming (P2, P3, P3) were used and compared with traditional programs (P1, chemical). Their effect in improving medicinal pumpkin seeds quality was examined. As a quality addition of supplying chain, the quantitative and qualitative content of vitamins C and D3 were assayed. This plant seeds are considered of healthy and medical importance, and have their marketing placement. A big amount of the seeds have been consumed directly by human year round. Using the seeds in food production processes increased their nutritional value. The field experiment was conducted on two dates. The design used was the randomized complete block design. All data were collected and analyzed according to ANOVA table using Duncan’s multiple range test at P= 0.05. The results obtained showed significant distinguish of the organic farming program (P3) compared to the rest the programs used. This treatment had significant increase of vitamins C and D3 content in the seeds in the two dates (0.0883 mg l-1, 0.08671 mg l-1, 12.38 mg l-1 and 12.32 mg l-1 respectively). The other two organic programs (P2, P4) were significantly distinct compared to the traditional one (P1). The study concluded that these studied organic programs can be an effective choice to improve seed quality of this crop. The healthy and nutritional value are enhanced, and the side effects of traditional agriculture on the environment are reduced

Rapid Mold Detection in Chinese Herbal Medicine Using Enhanced Deep Learning Technology.

Mold contamination poses a significant challenge in the processing and storage of Chinese herbal medicines (CHM), leading to quality degradation and reduced efficacy. To address this issue, we propose a rapid and accurate detection method for molds in CHM, with a specific focus on Atractylodes macrocephala, using electronic nose (e-nose) technology. The proposed method introduces an eccentric temporal convolutional network (ETCN) model, which effectively captures temporal and spatial information from the e-nose data, enabling efficient and precise mold detection in CHM. In our approach, we employ the stochastic resonance (SR) technique to eliminate noise from the raw e-nose data. By comprehensively analyzing data from eight sensors, the SR-enhanced ETCN (SR-ETCN) method achieves an impressive accuracy of 94.3%, outperforming seven other comparative models that use only the response time of 7.0 seconds before the rise phase. The experimental results showcase the ETCN model's accuracy and efficiency, providing a reliable solution for mold detection in Chinese herbal medicine. This study contributes significantly to expediting the assessment of herbal medicine quality, thereby helping to ensure the safety and efficacy of traditional medicinal practices.

Formulation and Evaluation of Soap Containing Extracts of Various Ethnomedicines

The herbal soap’s formulation includes neem leaf; all herbal ingredients are easily obtained from the local herbal market. Use of cosmetics is part of caring for the skin and other body parts due to the damaging effects of modern pollution and UV rays on human health; aloe plants produce a material used in cosmetic goods to treat burns, psoriasis, acne, and other skin disorders; preparation of herbal soap is a medication or therapy with therapeutic benefits for the skin, including antibacterial and antifungal qualities; the raw material used to make soap has a number of properties that make it a good medicinal or cosmetic. The plant used to manufacture soap has properties that can help eliminate acne, soften the skin’s epidermis, increase penetration, and hasten healing and resolution. Natural remedies like aloe vera are used to both prevent and cure a range of skin conditions. The medicinal properties of aloe vera soap include antiseptic, antimicrobial, antiviral, antioxidant, and antifungal properties. The aloe vera plant features tubular yellow blossoms, many-seeded fruits, and triangular, fleshy leaves with serrated edges. Each leaf consists of three layers: an inner, transparent gel that contains 99% water and glucomannans, amino acids, lipids, sterols, and vitamins in the remaining 2%. The intermediate layer of latex is composed of a bitter-yellow sap. Neem provides additional medicinal benefits. Studies have demonstrated the anti-inflammatory, anti-hyperglycemic, anti-ulcer, antimalarial, antifungal, antibacterial, antimutagenic, and anticarcinogenic properties of neem and its chemical components. Tulsi provides many skin-benefiting qualities, such as beep-clean skin. Turmeric and vitamin C are also used to help tone the skin when treating breakouts. Homegrown cleaning solutions with medicinal or sedative qualities, such as antimicrobial and antifungal qualities, can benefit the skin. The rough material used in the cleanser formulation has multiple prescription drugs or cosmetics attached to it. The plant used in cleanser formulations has the ability to smooth out skin imperfections, enhance skin texture, prevent breakouts, and hasten healing and resolution.

Genome resequencing reveals the genetic basis of population evolution, local adaptation, and rewiring of the rhizome metabolome in Atractylodes lancea.

The formation of high-quality Chinese medicinal materials is a micro-evolutionary process of multiple genes involving quantitative inheritance under environmental stress. Atractylodes lancea is a traditionally used medicinal plant in China that is broadly distributed and possesses a considerable amount of essential oils. However, to date, limited research has been conducted to characterize the genetics and metabolites of A. lancea shaped by natural variation. Hence, we assembled a high-quality genome of A. lancea, featuring a contig N50 of 1.18Mb. We further integrated population resequencing of A. lancea and conducted analyses to characterize its genetic diversity, population evolution, and rewiring of volatile metabolites. The natural variation effect exerted significant pressure on A. lancea from different geographic locations, resulting in genetic differentiation among three groups. Correlation analysis of metabolites in A. lancea revealed significant natural variations of terpenoids, heterocyclic compounds, ketones, and esters. We also found that 427 metabolites displayed noteworthy divergence due to directional selection. Additionally, our genome-wide association studies on the metabolome for medicinal quality traits identified several candidate genes, such as AlZFP706 and AlAAHY1, exhibiting significant correlations with atractylodin and hinesol levels, respectively. Overall, this study provides an intricate genomic resource for A. lancea, thereby expanding our understanding of the effect of natural variation on metabolites and facilitating the genetic improvement of its medicinal properties.

Improvement of Microbiological Methods for Testing the Quality of Non-sterile Medicines with Antimicrobial Effects

INTRODUCTION. Microbiological testing of any medicine begins with the determination of its antimicrobial activity—that is, its effect on the growth of aerobic bacteria, yeasts, and moulds. Therefore, the improvement of microbiological testing methods to enhance the quality of resulting data remains a high priority.AIM. The study aimed to develop a methodological approach to testing non-sterile medicines with antimicrobial effects for microbiological quality, as well as to improve the accuracy and reliability of existing microbiological testing methods.MATERIALS AND METHODS. The study used 12 non-sterile pharmaceuticals, 5 diluents (phosphate buffer solution, phosphate buffer solution with polysorbate 80 (1% and 5%), neutralising fluid, and trypticase soy broth), culture media, and test strains required for microbiological quality testing according to the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of the Eurasian Economic Union.RESULTS. This study established microbiological testing conditions for non-sterile medicines with known antimicrobial effects. The analytical procedures developed in the study were tested on 10 medicines. The authors demonstrated the applicability of analytical procedures for the quantitative determination of microscopic fungi in samples with fungistatic activity. The proliferation factors in growth promotion tests with Candida albicans and Aspergillus brasiliensis were within the acceptable range of 76–128% of the calculated value for a standardised inoculum. The authors proposed a modification to the analytical procedure for the qualitative determination of Escherichia coli; the modification involved using a 50 mL sample at a 1:50 dilution, corresponding to 1 g of the test product, for transfer to 450 mL of an appropriate culture medium. Having compared diluents containing non-specific agents neutralising antimicrobial activity, the authors showed that the neutralising fluid should be preferred.CONCLUSIONS. The authors proposed a methodological approach to microbiological quality testing of medicines, postulating that the results should be considered reliable only if they account for the antimicrobial activity of the test product. The study demonstrated the feasibility of increasing the sample volume up to 10 mL and using a dilution exhibiting no antimicrobial activity (e.g., 1:100). The authors recommended using 150 mm Petri dishes, 50 mL of an agarised culture medium, and diluents with up to 5% of polysorbate 80 for plating. The study demonstrated the suitability of using a dilution exhibiting no antimicrobial activity. The study results indicated the need to increase the sample volume to be proportionally transferred to a culture medium; the sample should contain the amount of the test product regulated by pharmacopoeias (i.e., not less than 1 g (1 mL)). Diluents with up to 5% of polysorbate 80 were recommended for neutralising bacteriostatic and fungistatic effects.

Atypical enantioseparation of a non-ionic form of allantoin with Cinchona alkaloid-based zwitterionic chiral stationary phases

Allantoin represents a compound widely employed in pharmaceutical and cosmetic fields. Its safety has been acknowledged by regulatory bodies such as the US Food and Drug Administration, the European Commission for Cosmetics and Consumer and Health and European Directorate for the Quality of Medicines & HealthCare. This justifies its wide use in dermatological/cosmetic formulations and allows their safe use.Allantoin possesses an asymmetric carbon atom, resulting in two enantiomers, with the (S)-enantiomer predominating in plants, although racemization may potentially occur during manufacturing processes. Notably, literature currently lacks enantioselective LC methods for allantoin analysis.In this study, two zwitterionic Cinchona alkaloid-based chiral stationary phases (CSPs), commercially known as CHIRALPAK® ZWIX(+) (CSP1) and CHIRALPAK® ZWIX(-) (CSP2), were utilized for the enantioseparation of allantoin under polar-ionic conditions. By employing a mobile phase consisting of acetonitrile/methanol/water/acetic acid (96:2:2:0.1, v/v/v/v), nearly complete baseline separation (with α=1.08) of allantoin enantiomers was achieved in less than 15 min with both CSPs. Due to the “pseudo-enantiomeric” nature of the two chiral selectors (quinine-based in CSP1 and quinidine-based in CSP2), an inversion of the enantiomer elution order was observed with the two CSPs under identical experimental conditions. Remarkably, this represents a rare instance where these CSPs demonstrate the ability to enantioseparate a non-ionic, non-ionizable species.The application of a molecular dynamics in silico protocol proved useful in elucidating the retention mechanism in depth, casting light on the central role of the H-bond formation and the involvement of the anionic moiety of the CSP 1.

A Physiological and Molecular Docking Insight on Quercetin Mediated Salinity Stress Tolerance in Chinese Flowering Cabbage and Increase in Glucosinolate Contents.

The present study was performed to investigate the negative impact of salinity on the growth of Chinese flowering cabbage (Brassica rapa ssp. chinensis var. parachinensis) and the ameliorative effects of quercetin dihydrate on the plant along with the elucidation of underlying mechanisms. The tolerable NaCl stress level was initially screened for the Chinese flowering cabbage plants during a preliminary pot trial by exposing the plants to salinity levels (0, 50, 100, 150, 200, 250, 300, 350, and 400 mM) and 250 mM was adopted for further experimentation based on the findings. The greenhouse experiment was performed by adopting a completely randomized design using three different doses of quercetin dihydrate (50, 100, 150 µM) applied as a foliar treatment. The findings showed that the exposure salinity significantly reduced shoot length (46.5%), root length (21.2%), and dry biomass (32.1%) of Chinese flowering cabbage plants. Whereas, quercetin dihydrate applied at concentrations of 100, and 150 µM significantly diminished the effect of salinity stress by increasing shoot length (36.8- and 71.3%), root length (36.57- and 56.19%), dry biomass production (51.4- and 78.6%), Chl a (69.8- and 95.7%), Chl b (35.2- and 87.2%), and carotenoid contents (21.4- and 40.3%), respectively, compared to the plants cultivated in salinized conditions. The data of physiological parameters showed a significant effect of quercetin dihydrate on the activities of peroxidase, superoxide dismutase, and catalase enzymes. Interestingly, quercetin dihydrate increased the production of medicinally important glucosinolate compounds in Chinese flowering cabbage plants. Molecular docking analysis showed a strong affinity of quercetin dihydrate with three different stress-related proteins of B. rapa plants. Based on the findings, it could be concluded that quercetin dihydrate can increase the growth of Chinese flowering cabbage under both salinity and normal conditions, along with an increase in the medicinal quality of the plants. Further investigations are recommended as future perspectives using other abiotic stresses to declare quercetin dihydrate as an effective remedy to rescue plant growth under prevailing stress conditions.

On-site analysis and rapid identification of citrus herbs by miniature mass spectrometry and machine learning.

Natural medicines present a considerable analytical challenge due to their diverse botanical origins and complex multi-species composition. This inherent complexity complicates their rapid identification and analysis. Tangerine peel, a product of the Citrus species from the Rutaceae family, is widely used both as a culinary ingredient and in traditional Chinese medicine. It is classified into two primary types in China: Citri Reticulatae Pericarpium (CP) and Citri Reticulatae Pericarpium Viride (QP), differentiated by harvest time. A notable price disparity exists between CP and another variety, Citri reticulatae "Chachi" (GCP), with differences being based on the original variety. This study introduces an innovative method using portable miniature mass spectrometry for swift on-site analysis of QP, CP, and GCP, requiring less than a minute per sample. And combined with machine learning to differentiate the three types on site, the method was used to try to distinguish GCP from different storage years. This novel method using portable miniature mass spectrometry for swift on-site analysis of tangerine peels enabled the characterization of 22 compounds in less than one minute per sample. The method simplifies sample processing and integrates machine learning to distinguish between the CP, QP, and GCP varieties. Moreover, a multiple-perceptron neural network model is further employed to specifically differentiate between CP and GCP, addressing the significant price gap between them. The entire analytical time of the method is about 1minute, and samples can be analyzed on site, greatly reducing the cost of testing. Besides, this approach is versatile, operates independently of location and environmental conditions, and offers a valuable tool for assessing the quality of natural medicines.

Marine-derived Anti-Tuberculosis compounds

Tuberculosis (TB), which is caused primarily by Mycobacterium tuberculosis, is the largest cause of death among all infectious diseases, accounting for more than two million fatalities each year. Marine natural products and some of their derivatives have been found to have potent antitubercular activity against Mycobacterium TB, and some of them have been chosen as prototype molecules for the development of novel anti-tubercular drugs. Because of their strong medicinal qualities, a variety of marine natural products such as terpenoids, alkaloids, pyrones, sterols, and quinones derived from marine sources have piqued interest in recent decades. In this review study, we present current discoveries on the anti-tubercular action of marine natural products, emphasizing their medicinal potential for the treatment of tuberculosis. Based on the research from the last decade, this review provides a full grasp of marine natural products as anti-tubercular agents, as well as a plausible mechanism of action.

STRATEGIC IMPERATIVES FOR DIGITISATION OF THE UKRAINIAN PHARMACEUTICAL INDUSTRY

The purpose of the paper is to identify the strategic imperatives of the pharmaceutical industry in the context of the development of the digital economy. Inclusion of the pharmaceutical industry in the list of priority sectors of the economy will help attract state investment support for production and increase the number of jobs. This will help to prevent a collapse in the supply of medicines and medical devices to the healthcare system and ensure their uninterrupted production and supply to the end consumer. The population of Ukraine will have access to quality medicines and medical products. Methodology. The article presents an analysis of the indicators of the pharmaceutical industry for the period 2019-2023. These include the volume of import and export of pharmaceutical products, the structure of the main marketing organisations in the pharmaceutical market, leading drugs in terms of sales volume on the Ukrainian market, the structure of sales of "pharmacy basket" products, and the volume of hospital supplies in terms of funding sources. This paper analyses the main trends of digitisation in the pharmaceutical industry at the global level and in Ukraine in particular. A SWOT analysis was conducted to assess the development of the pharmaceutical industry in Ukraine. The analysis focused on identifying the key factors that contribute to the successful development of e-commerce in the pharmaceutical industry. Results. The publication identifies the main positive and negative manifestations of digitalisation of the pharmaceutical industry in Ukraine and the factors that hinder its development. Practical implications. Thus, the introduction of digitalisation tools in the Ukrainian pharmaceutical industry is an important step towards improving its competitiveness. The deployment of smart manufacturing systems makes it possible to produce medicines faster and more accurately. Such technological solutions can help to optimise the supply chain, which is important for the pharmaceutical industry, where the accuracy and speed of supply of medicines is critical. The use of digital technologies improves control over the safety of pharmaceutical products and increases production efficiency. Automation of business processes through the use of AI, VR, AR, cloud computing, big data, etc. can help reduce production costs and improve product quality. However, the implementation of digitalisation technologies in the pharmaceutical industry also requires significant investments and qualified personnel, which may temporarily reduce competitiveness due to higher prices for finished products.

Rapid and comprehensive quality evaluation of Huang-qin from different origins by FT-IR and NIR spectroscopy combined with chemometrics.

Quality evaluation of Huang-qin is significant to ensure its clinical efficacy. This study aims to establish an accurate, rapid and comprehensive Huang-qin quality evaluation method to overcome the time-consuming and laborious shortcomings of traditional herbal medicine quality assessment methods. The contents of baicalin, baicalein and scutellarin in Huang-qin from five different origins were analyzed by FT-IR and NIR spectra combined with multivariate data technology. The quality of Huang-qin from different origins was evaluated by TOPSIS and consistency analysis based on the content of three active ingredients. The correlation between ecological factors and the accumulation of active ingredients was explored. Satisfactory prediction results of PLS models were obtained. Relatively, the model based on FT-IR combined with the PLS regression method has higher R2 and smaller RMSE than the NIR combined with the PLS method. TOPSIS and consistency analysis results showed that the quality of Huang-qin from different geographical origins was significantly different. The results showed that the quality of Huang-qin produced in Shanxi Province was the best among the five origins studied. The results also found that the quality of Huang-qin in different growing areas of the same origin was not completely consistent. The correlation study showed that altitude, sunshine duration and rainfall were the main factors that caused the quality difference of medicinal materials in different geographical origins. This study provides a reference for the rapid quantitative analysis of the active components of herbal medicine and the quality evaluation of them.

Landscape assessment of the availability of medical abortion medicines in India

BackgroundMedical abortion with mifepristone and misoprostol can be provided up to 63 days’ gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India.MethodsWe applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021.ResultsMedicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment.ConclusionOpportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed.

Why Assuring the Quality of Antimicrobials Is a Global Imperative.

Poor-quality antimicrobial medicines continue to proliferate across supply chains, threatening patients' health and safety, especially in low- and middle-income regions. This article discusses consequences and risks of antimicrobial resistance and other ways in which antimicrobial medicines can be of poor quality and recommends regulatory and policy reforms to help maintain supply chain resilience and quality of antimicrobial medicines.

Telling Time: Patient Experiences of Temporality in Brain Tumor Comics.

This article explores three different comics by creators with brain tumors: Rick, written and drawn by Gordon Shaw; Going Remote, written by Adam Bessie and drawn by Peter Glanting; and Parenthesis, written and drawn by Élodie Durand. It examines how the affordances of the comics medium enables the creators to present an experience of subjective time that is multiple, diffuse, and contradictory, in contrast to the regular apportioning of time via calendars, schedules, and pathways essential to institutional neuro-oncology. The question of time here is significant because the side effects of brain tumors can include blackouts, seizures, and periods of extreme fatigue, during which the experience of time can be significantly disrupted. The title of the article therefore evokes a temporal duality: on the one hand, it refers to the common phrase used to describe what clocks do, as well as our ability to read them; on the other hand, it speaks to one of the most important qualities of graphic medicine, which is that it allows patients dealing with medical or health issues to tell time differently. The article explores the representation of personal time in Rick, social time in Going Remote, and lost time in Parenthesis.

Experience on Utilization of Novel Modeling &amp; Simulation Approaches in Generic Product Development

Modeling and simulation approaches such as Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modeling (PBBM) are gaining importance due to their impact to transform drug development paradigm. Development of such modeling approaches include integration of drug substance, drug product and physiological aspects followed by validation against clinical data. In this manuscript, we have highlighted utility of PBPK and PBBM in generic product development using case examples. An application where PBBM was utilized to obtain biowaivers and dissolution safe space was portrayed. Utility of such modeling approaches in obtaining fed bioequivalence studies was discussed with case example. Impact of gender evaluation on bioequivalence study outcome using PBPK approach was highlighted with a case example. Evaluation of safety aspects of extended release formulation with help of modeling approach was discussed with practical example. In the last case study, understanding the impact of critical bioavailability attributes with help of PBBM was indicated. Further, future direction in terms of sharing best practices across academia, industry and regulatory was highlighted. Overall, this manuscript summarizes experience on utilization of modeling and simulation approaches in generic product development with an aim to have more affordable and quality medicines to the patients.

Development of a high-speed and ultrasensitive UV/Vis-CM for detecting total triterpenes in traditional Chinese medicine and its application

This study proposes a novel colorimetric method based on the ultraviolet/visible spectrophotometry-colorimetric method (UV/Vis-CM) for detecting and quantifying total triterpenoids in traditional Chinese medicine. By incorporating the colourants 2-hydroxy-5-methylbenzaldehyde and concentrated sulfuric acid, triterpenoid compounds colour development became more sensitive, and the detection accuracy was significantly improved. 2-hydroxy-5-methylbenzaldehyde and concentrated sulfuric acid were incorporated in a 1:3 vol ratio at room temperature to react with the total triterpenes for 25 min, incorporated to an ice bath for 5 min, and then detected at the optimal absorption wavelength. The accuracy and reliability of this method were verified by comparison with high-performance liquid chromatography and four other colorimetric methods. Additionally, this approach has the advantages of not requiring heating during operation, high sensitivity, short usage time, low solvent usage, and low equipment costs. This study not only offers a reliable method for detecting total triterpenes in traditional Chinese medicine but also offers a rapid detection tool for on-site testing and large-scale screening, laying a foundation for the modernization of traditional Chinese medicine research, quality control, and drug development.