“Insight” into Drug Quality: Comparison of Simvastatin Tablets from the US and Canada Obtained via the Internet

2007 ◽  
Vol 41 (7-8) ◽  
pp. 1111-1115 ◽  
Author(s):  
Michael A Veronin ◽  
Eunah Lee ◽  
E Neil Lewis

Background: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US. Objective: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product. Methods: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis, Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets’ internal structures. Results: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets. Conclusions: Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.

2008 ◽  
Vol 42 (5) ◽  
pp. 613-620 ◽  
Author(s):  
Michael A Veronin ◽  
Nga T Nguyen

Background: Convenient access to prescription drugs produced outside the US has been facilitated by the Internet. Of greatest concern to clinicians and policy-makers is product quality and patient safety. The Food and Drug Administration has issued warnings to potential buyers that the safety of drugs purchased through the Internet cannot be guaranteed and may present consumers with a health risk from substandard products. Objective: To determine whether generic simvastatin tablets and capsules obtained via the Internet from international markets are equivalent to the US innovator product regarding major aspects of pharmaceutical quality. Methods: Twenty simvastatin tablets and capsules were obtained for pharmaceutical analysis: 19 generic samples from international Internet pharmacy Web sites and the US innovator product. Tablet samples were tested according to US Pbarmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. These tests are often used to detect formulation defects of drug products during the manufacturing process. Results: Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution and 2 for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization. Conclusions: Results suggest that manufacturing standards for the international generic drug products compared with the US innovator product are not equivalent with regard to quality attributes. These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet.


2021 ◽  
Vol 5 ◽  
pp. 239920262110020
Author(s):  
Tomoko Sanada ◽  
Myu Ohnishi ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Hirohito Tsuboi

Background: Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan®), an antifungal medicine used to treat deep mycoses, as “female Viagra®.” Aim: The aim of this study was to investigate the authenticity and quality of Diflucan® tablets distributed on the Internet. Methods: We ordered Diflucan® tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy. Results: We obtained 11 samples of Diflucan® tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan® samples were confirmed as genuine and one sample was falsified. The genuine Diflucan® samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan® sample obtained in this study differed from the authentic Diflucan® tablet. The falsified Diflucan® sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan® tablet obtained in this study differed from the authentic Diflucan® tablet in near-infrared and Raman scattering spectroscopy. Conclusion: We confirmed that one falsified Diflucan® tablet was distributed online. Thus, continued measures against falsified medicines are required.


Think India ◽  
2019 ◽  
Vol 22 (2) ◽  
pp. 174-187
Author(s):  
Harmandeep Singh ◽  
Arwinder Singh

Nowadays, internet satisfying people with different services related to different fields. The profit, as well as non-profit organization, uses the internet for various business purposes. One of the major is communicated various financial as well as non-financial information on their respective websites. This study is conducted on the top 30 BSE listed public sector companies, to measure the extent of governance disclosure (non-financial information) on their web pages. The disclosure index approach to examine the extent of governance disclosure on the internet was used. The governance index was constructed and broadly categorized into three dimensions, i.e., organization and structure, strategy & Planning and accountability, compliance, philosophy & risk management. The empirical evidence of the study reveals that all the Indian public sector companies have a website, and on average, 67% of companies disclosed some kind of governance information directly on their websites. Further, we found extreme variations in the web disclosure between the three categories, i.e., The Maharatans, The Navratans, and Miniratans. However, the result of Kruskal-Wallis indicates that there is no such significant difference between the three categories. The study provides valuable insights into the Indian economy. It explored that Indian public sector companies use the internet for governance disclosure to some extent, but lacks symmetry in the disclosure. It is because there is no such regulation for web disclosure. Thus, the recommendation of the study highlighted that there must be such a regulated framework for the web disclosure so that stakeholders ensure the transparency and reliability of the information.


2019 ◽  
Vol 3 (4) ◽  
Author(s):  
J Michael Brick ◽  
Andrew Caporaso ◽  
Douglas Williams ◽  
David Cantor

Decisions on public policy can be affected if important segments of the population are systematically excluded from the data used to drive the decisions. In the US, Spanishspeakers make up an important subgroup that surveys conducted in English-only underrepresent. This subgroup differs in a variety of characteristics and they are less likely to respond to surveys in English-only. These factors lead to nonresponse biases that are problematic for survey estimates. For surveys conducted by mail, one solution is to include both English and Spanish materials in the survey package. For addresses in the US where Spanish-speakers are likely to be living, this approach is effective, but it still may omit some non-English-speakers. Traditionally, including both English and Spanish materials for addresses not identified as likely to have Spanish-speakers was considered problematic due to concerns of a backlash effect. The backlash effect is that predominantly English-speakers might respond at a lower rate because of the inclusion of Spanish materials. Prior research found no evidence of a backlash, but used a twophase approach with a short screener questionnaire to identify the eligible population for an education survey. In this paper, we report on experiments in two surveys that extend the previous research to criminal victimization and health communication single-phase surveys. These experiments test the effect of the inclusion of Spanish language materials for addresses not identified as likely to have Spanish-speakers. Our findings confirm most results of the previous research; however we find no substantial increase in Spanish-only participation when the materials are offered in both languages for addresses that are not likely to have Spanish-speakers. We offer some thoughts on these results and directions for future research, especially with respect to collecting data by the Internet.


Author(s):  
Ji-Hyun Lee ◽  
Jin-Hee Ha

This study evaluated the effectiveness of a microcurrent toothbrush (approved by the US Food and Drug Administration [FDA]), which employs a superimposed alternating and direct electric current, named as a Proxywave® technology, similar to the intensity of the biocurrent, in plaque removal and reducing gingivitis by biofilm removal through the bioelectric effect. This study enrolled 40 volunteers with gingivitis. Dental observations were made every two weeks, before and after the use of each toothbrush. We randomly assigned participants into two groups: one group used the Proxywave® toothbrush (PB) for two weeks followed by the control toothbrush (CB) for two weeks, while the other group used the CB for two weeks followed by the PB. The participants had a two-week washout period. If the toothbrush used earlier has had an effect on the bacterial flora in the oral cavity, this is to remove this effect and return it to its previous state. During each dental visit, we recorded plaque index (PI) and gingival index (GI) scores. The PI and GI scores were significantly lower in both the PB and the CB (p < 0.05). Considering the PI, there was no significant difference between the toothbrushes on all the surfaces. Considering the GI, the PB showed a significant decrease in the interproximal surface, compared to the CB (p < 0.05). The PB showed a significant decrease in the interproximal GI and had a beneficial effect in the interproximal area where the bristles could not reach. No adverse events were observed in the participants during the clinical trial. The microcurrent toothbrush is a device that can be safely used for plaque removal.


2021 ◽  
Vol 6 (3) ◽  
pp. 111
Author(s):  
Sherry Zhang ◽  
Isabella Lopez ◽  
Bernard Washington ◽  
Brittney Gaudet ◽  
Carina A. Rodriguez ◽  
...  

In adults, data support the utility and acceptance of home HIV testing; however, in youth, particularly in the US, this has not been well studied. In this exploratory study, we surveyed Tampa Bay youth aged 16−27 and attending sexual health clinics between 1 June and 31 June 2018 (n = 133) regarding attitudes and perceptions towards HIV self-testing. While most indicated the clinic over home when asked for preferred testing location, study population and subgroup analysis demonstrated a positive response (agree) to Likert-scale questions regarding the use of home HIV self-testing kits and negative responses (strongly disagree) to “would not use self-testing kit”. There was a significant difference between genders in testing location preference (p = 0.031) for those respondents that specified gender (n = 123), with males more likely to prefer home testing than females. This study suggests an openness of youth towards HIV home testing that could help to expand the number of youth aware of their HIV status.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1833.2-1833
Author(s):  
B. C. Detlef ◽  
S. El-Nawab-Becker ◽  
M. Toellner ◽  
A. Kleinheinz ◽  
T. Witte

Background:Nail psoriasis is an extreme diagnostic and therapeutic challenge and represents an enormous physical and psychological burden for affected patients.50% of patients with psoriasis vulgaris develop nail involvement (NailPso)during the course of their disease. NailPso is the strongest predictor of psoriatic arthritis (PsA). Through the synovio-enthesial concept we have learned that there is an anatomical-pathophysiological relationship between DIP joint, extensor tendon and nail matrix. We have observed in daily practice that hypervascularization (HV) in ultrasound Power Doppler (US-PD)the nail matrix may be a pathognomonic element in its own right. There are no data on this in the literature.Objectives:Is there a difference in the ultrasound PD examination of the DIP joint and nail area and in the capillary microscopy of the corresponding nail fold in patients with psoriasis vulgaris and nail psoriasis versus patients with psoriasis vulgaris without nail psoriasis.Methods:Monocentric prospective study of all consecutive patients with psoriasis vulgaris who have come to a rheumatic practice to clarify a PsA. Inaddition to demographic data, assessments (PASI,DLQI,CASPAR,GEPARD, DAS28, SJ,TJ,FFBH), clinical examination, a standardized ultrasound PD examination and capillary microscopy of the affected fingertips in PsO patients suffering from nail psoriasis was performed as well as corresponding examinations of the 2nd and 3rd finger right in PsO patients without nail involvement.Results:79 patients could be included during the study period. Thereof 25 PsO patients without nail involvement and 44 PsO patients with nail involvement. Since the patients were examined consecutively, the difference results. There was no difference in age, BMI and sex in both groups (Pso and NailPso). The Caspar criteria as classification criteria for a PsA were positive in 65% of the NailPso patients and positive in 50% of all PsO patients without nail infestation. Hypervascularization in the US-PD examination in the area of the nail matrix could be seen significantly more frequently in NailPso compared to non-NagelPso patients. Such a difference did not exist in the HV of the extensor tendons.Capillary microscopy showed a significant difference in the number of torsions/twist capillaries in NailPso compared to Pso patients without NailPso.Hypervascularization of the nail matrix is seen significantly more frequently in patients with psoriasis of the nail than in patients without psoriasis of the nail. Such a difference does not exist in DIP joint -extensor tendon- enthesitis. At the same time, torsions are significantly more frequently seen in capillary microscopy in NailPso than in patients without NailPso.Conclusion:The US-PD examination is a simple and non-invasive procedure which can be performed routinely in daily practice. The hypervascularization of the nail matrix should also make one think of nail psoriasis in the early stage of PsO, in order to be able to start early an appropriate therapy for this very stigmatizing and therapeutically extremely difficult manifestation of PsO. It seems to occur independently of extensor tendon synovitis as an independent manifestation phenomenon.The occurrence of torsions in capillary microscopy >50 % also seems to be groundbreaking for a NagelPso, whereby capillary microscopy is a temporal challenge in daily routine.References:§ The present study (7734-BO-S2018 Ethics Commission of the MHH, Medical School Hannover, Germany) contains parts of the PhD thesis of M.TöllnerDisclosure of Interests:Becker-Capeller Detlef Grant/research support from: Novartis, Speakers bureau: Pfizer, Soham El-Nawab-Becker: None declared, Malo Toellner: None declared, Andreas Kleinheinz: None declared, Torsten Witte: None declared


Sensors ◽  
2021 ◽  
Vol 21 (9) ◽  
pp. 3052
Author(s):  
Mas Ira Syafila Mohd Hilmi Tan ◽  
Mohd Faizal Jamlos ◽  
Ahmad Fairuz Omar ◽  
Fatimah Dzaharudin ◽  
Suramate Chalermwisutkul ◽  
...  

Ganoderma boninense (G. boninense) infection reduces the productivity of oil palms and causes a serious threat to the palm oil industry. This catastrophic disease ultimately destroys the basal tissues of oil palm, causing the eventual death of the palm. Early detection of G. boninense is vital since there is no effective treatment to stop the continuing spread of the disease. This review describes past and future prospects of integrated research of near-infrared spectroscopy (NIRS), machine learning classification for predictive analytics and signal processing towards an early G. boninense detection system. This effort could reduce the cost of plantation management and avoid production losses. Remarkably, (i) spectroscopy techniques are more reliable than other detection techniques such as serological, molecular, biomarker-based sensor and imaging techniques in reactions with organic tissues, (ii) the NIR spectrum is more precise and sensitive to particular diseases, including G. boninense, compared to visible light and (iii) hand-held NIRS for in situ measurement is used to explore the efficacy of an early detection system in real time using ML classifier algorithms and a predictive analytics model. The non-destructive, environmentally friendly (no chemicals involved), mobile and sensitive leads the NIRS with ML and predictive analytics as a significant platform towards early detection of G. boninense in the future.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1086.2-1087
Author(s):  
T. Okano ◽  
T. Koike ◽  
K. Inui ◽  
K. Mamoto ◽  
Y. Yamada ◽  
...  

Background:In rheumatoid arthritis (RA), biologics treatment is one of the effective treatment options. Usually, there is no difference in therapeutic effect regardless of which biologics is used, but the effect for joint synovitis is unknown. Recently, ultrasound (US) has played a role of sensitive imaging modality in the diagnosis and follow-up of patients with RA.Objectives:The aim of this study was to compare the improvement of US findings between TNF inhibitors and non-TNF inhibitors at first biologics in patients with RA.Methods:Fifty-four RA patients who started the first biologics from September 2016 to December 2018 were included in this longitudinal study (SPEEDY study, UMIN000028260). All the patients were performed clinical examination, blood test and US examination at baseline, 4, 12, 24, 36 and 52 weeks. A US examination was performed at the bilateral first to fifth metacarpophalangeal (MCP) joints, first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) joints, wrist joints (three part of radial, medial and ulnar) and first to fifth metatarsophalangeal (MTP) joints, by using HI VISION Ascendus (Hitachi Medical Corporation, Japan) with a multifrequency linear transducer (18-6 MHz). The gray scale (GS) and power Doppler (PD) findings were assessed by the semi-quantitative method (0-3). GS score and PD score (both 0-108 points) were defined as the sum of each score. The change of disease activity and US findings were compared between TNF group and non-TNF group.Results:Among 54 cases, 32 patients were used TNF inhibitor and 22 were non-TNF inhibitor. Age and duration of RA were significantly higher in the non-TNF group, and MTX dose was significantly lower in the non-TNF group. The baseline inflammatory markers tended to be higher in the non-TNF group and the disease activity was also higher in the non-TNF group. However, the US findings showed no significant difference in both GS and PD between two groups at baseline. US improvement ratio was no difference between TNF group and non-TNF group at 4, 12, 24, 36 and 52 weeks in both GS and PD score. Regardless of the type of biologics, patients with long-term disease duration tended to have poor improvement in US synovial fingings.Table 1.Baseline patient and disease characteristicsTNF (n=32)non-TNF (n=22)P valueFemale patients, n (%)21 (65.6)16 (72.7)0.767Age (years)63.5±15.471.0±9.00.030Disease duration (years)6.5±8.213.0±11.70.032CRP (mg/dl)1.8±2.53.0±3.20.170DAS28-ESR5.0±1.45.8±1.20.022GS score26.1±18.831.8±21.10.313PD score17.6±11.423.1±14.60.150Figure 1.GS and PD improvement ratio at 4, 12, 24, 36 and 52 weeksConclusion:There was no difference in the US findings improvement between patients with TNF inhibitor and non-TNF inhibitor at first biologics in patients with RA.References:[1]Grassi W, Okano T, Di Geso L, Filippucci E. Imaging in rheumatoid arthritis: options, uses and optimization. Expert Rev Clin Immunol. 2015;11:1131-46.[2]Nishino A, Kawashiri SY, Koga T, et al. Ultrasonographic Efficacy of Biologic andTargeted Synthetic Disease-ModifyingAntirheumatic Drug Therapy in RheumatoidArthritis From a Multicenter RheumatoidArthritis Ultrasound Prospective Cohort in Japan. Arthritis Care Res (Hoboken). 2018;70:1719-26.Acknowledgements:We wish to thank Atsuko Kamiyama, Tomoko Nakatsuka for clinical assistant, Setsuko Takeda, Emi Yamashita, Yuko Yoshida, Rika Morinaka, Hatsue Ueda and Tomomi Iwahashi for their special efforts as a sonographer and collecting data.Disclosure of Interests:None declared


2020 ◽  
Vol 57 (6) ◽  
pp. 341-347
Author(s):  
Jaeyeon Chung ◽  
Sang-Hwan Ji ◽  
Young-Eun Jang ◽  
Eun-Hee Kim ◽  
Ji-Hyun Lee ◽  
...  

Near-infrared spectroscopy devices can measure peripheral tissue oxygen saturation (StO<sub>2</sub>). This study aims to compare StO<sub>2</sub> using INVOS® and different O3™ settings (O3<sup>25:75</sup> and O3<sup>30:70</sup>). Twenty adults were recruited. INVOS® and O3™ probes were placed simultaneously on 1 side of forearm. After baseline measurement, the vascular occlusion test was initiated. The baseline value, rate of deoxygenation and reoxygenation, minimum and peak StO<sub>2</sub>, and time from cuff release to peak value were measured. The parameters were compared using ANOVA and Kruskal-Wallis tests. Bonferroni’s correction and Mann-Whitney pairwise comparison were used for post hoc analysis. The agreement between StO<sub>2</sub> of devices was evaluated using Bland-Altman plots. INVOS® baseline value was higher (79.7 ± 6.4%) than that of O3<sup>25:75</sup> and O3<sup>30:70</sup> (62.4 ± 6.0% and 63.7 ± 5.5%, respectively, <i>p</i> &#x3c; 0.001). The deoxygenation rate was higher with INVOS® (10.6 ± 2.1%/min) than with O3<sup>25:75</sup> and O3<sup>30:70</sup> (8.4 ± 2.2%/min, <i>p</i> = 0.006 and 7.5 ± 2.1%/min, <i>p</i> &#x3c; 0.001). The minimum and peak StO<sub>2</sub> were higher with INVOS®. No significant difference in the reoxygenation rate was found between the devices and settings. The time to reach peak after cuff deflation was faster with INVOS® (both <i>p</i> &#x3c; 0.001). Other parameters were similar. There were no differences between the different O3™ settings. There were differences in StO<sub>2</sub> measurements between the devices, and these devices should not be interchanged. Differences were not observed between O3™ device settings.


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