Bioequivalence & Bioavailability International Journal最新文献

{"title":"Monkeypox Re-Emergence after Covid-19 Crisis","authors":"Hussain S","doi":"10.23880/beba-16000170","DOIUrl":"https://doi.org/10.23880/beba-16000170","url":null,"abstract":"Several contagious illness outbreaks have devastated the globe over the past. With the plethora of potential and reappearing infections such as MXP on the upswing, it is past time to draw lessons and insights from previous outbreaks to guide and effectively prepare for potential future outbreaks. Monkeypox (MXP) is a new zoonotic disease that has emerged as the most common orthopoxvirus infection in people since the elimination of smallpox. MXP's clinical manifestations are identical to that of smallpox. The illness is endemic in the Democratic Republic of the Congo (DRC), although other nations in Central Africa (CA) and West Africa (WA) have documented human cases or wildlife transmission. The MXP was also identified for the first time in the United States (US) in 2003. The condition has long been thought to be uncommon and self-limiting, although infrequent cases imply differently. Regrettably, the information gathered is scarce, fragmented, and sometimes inaccurate. Human MXP cases have grown in incidence and regional distribution in past years because there are significant gaps in knowledge of the condition's origin, epidemiology, and biology. The MXP virus is an elevated virus that infects a serious publichealth problem. As a result, there seems to be a necessity to emphasize developing surveillance capabilities that will give vital data for establishing suitable preventative, readiness, and response operations.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81763896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bioequivalence Study of Two Formulations of Cefixime","authors":"Setiawati E","doi":"10.23880/beba-16000169","DOIUrl":"https://doi.org/10.23880/beba-16000169","url":null,"abstract":"Cefixime is a broad-spectrum oral antibiotic used for treating a wide variety of bacterial infections. Study Objective: The objective of this study was to find out whether bioequivalence study of Cefixime 200 mg, Profim® capsule manufactured by PT Promedrahardjo Farmasi Industri in comparison with Cefixime 100 mg, Cefspan® capsule manufactured by PT Dankos Farma, For PT Kalbe Farma Tbk, under license by Astellas Pharma Inc., Osaka – Japan. Methods: The study was conducted using an open-label, randomized, single-dose, two-periods, two-treatments, crossover study under fasting conditions with 8 (eight) days washed-out period between each period. According to the random design, a single oral dose of the test drug or reference drug was administered to 30 healthy male subjects after overnight fasting. The number of subjects who finished the study was twenty-eight (28) healthy male subjects. Serial plasma samples were obtained over a 32 hours period. Plasma concentrations of the drug were determined by LC-MS/MS method. From the Cefixime concentration vs. time curves, the following pharmacokinetic parameters were obtained: AUC0-32h, AUC0-∞, and Cmax, while the statistical interval proposed was 80.00 - 125.00% for AUC0-32h and Cmax with 90% Confidence Interval (CI) with α = 5.00%. The estimation of Tmax and T1/2 in the bioequivalence study was based on a nonparametric statistical procedure on the original data using Wilcoxon Sign Test. Results: The main pharmacokinetic parameters of the test drug Profim® (BN: B051A21P-1)/ reference drug, Cefspan® (BN: KCEFB00038) ratio were as follows: AUC0-32h: 105.86 (95.41 - 117.44) with CV Intra Subjects was 22.72% and Cmax: 105.63 (95.33 - 117.03) with CV Intra Subjects was 22.43 %. Whilst TMAX of the test drug Profim® (BN: B051A21P-1)/ reference drug, Cefspan® (BN: KCEFB00038) were respectively 4.50 (3.50 – 6.00) h and 4.50 (3.00 – 6.00) h; mean T1/2 were respectively 4.18 ± 0.78 h and 4.14 ± 0.56 h; and mean Slope were respectively (-0.17) ± 0.03 h and (-0.17) ± 0.02 h. There is no adverse event that occurred during this study. Conclusion: The present study demonstrated that the evaluated test drug Profim® (BN: B051A21P-1) were bioequivalence in term of both rate and extent of absorption to the reference drug Cefspan® (BN: KCEFB00038).","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75827305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emerging Approaches and Perception of Toxicity Assessment in Nanomaterials","authors":"L. S.","doi":"10.23880/beba-16000168","DOIUrl":"https://doi.org/10.23880/beba-16000168","url":null,"abstract":"In the 21st century, nanotechnology, an interdisciplinary research has become an innovative field and made a new revolution in science and technology. Its unique properties has led an extensive research interest among the researchers and utilized in various fields including biomedical applications. Increased use of nanomaterials in health sciences and medicine aroused a global concern on the biological response, effectiveness, and toxicity of these materials. Therefore, it has become imperative in studying the toxicity of nanomaterial (Nanotoxicology) in therapeutic applications. The main aim of nanotoxicological studies is to determine the toxic/hazardous effects of nanomaterials on humans and to the environment. The toxicity of the nanomaterials depends on various physicochemical properties such as size, shape, surface area, surface chemistry, concentration and several others parameters. Nanomaterials have shown higher toxicity particularly in inhalation studies, hence stringent regulations are made for nanotechnology products to ensure the safety of the products. There are few approaches to overcome these toxicities and improve its therapeutic efficacy and safety. Hence development of nanotechnology should occur on par with risk assessment to identify and subsequently avoid possible dangers in the near future. This article highlights on the different nanomaterials, their unique properties and frameworks for assessing the toxicity of nanomaterials.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86426530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bioequivalence Trial of Two Piracetam 800 Mg ImmediateRelease Oral Tablets in Mexicans: Insights in the Use and Abuse of Nootropics","authors":"Marcelín-Jimenez G","doi":"10.23880/beba-16000171","DOIUrl":"https://doi.org/10.23880/beba-16000171","url":null,"abstract":"Objective: To share pharmacokinetic data and a bio-analytical method for the conduction of a bioequivalence trial of Piracetam 800-mg immediate release tablets in Mexicans. Methods: Twelve male and 18 female healthy volunteers were administered with a single oral dose of one 800-mg Piracetam tablet under fasting conditions, in a cross-over design study, with blood sampling up to 24 h post-dose. Piracetam was measured by tandem Mass Spectrometry coupled to Ultra-Performance Liquid Chromatography (UPLC-MS/MS) using metronidazole as internal standard. Logarithmic ratios of maximal plasma concentration (Cmax ) and Area Under the Curve (AUC) were used to establish 90% Confidence Intervals [CI] for bioequivalence. Results: Both formulations (Nootropil™ as reference product, and PIRACETAM generic formulation as test product) were safe and well tolerated. The analytical method proved to be linear with accuracy and precision within a range of 1-60 µg/mL; 90% CI for and were [82.62–94.68] and [95.22–102.06]. Cmax was reached at approximately 1 h, and plasma elimination half-life (t1/2) was around 5.1 h for both products. Conclusion: Assayed products met the criteria established by the Mexican regulatory agency (COFEPRIS) to be declared bioequivalent. Mexican population appears to be a high absorber of Piracetam, exhibiting a 300% higher and an ABC0-inf 60% greater than other populations previously reported.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82890515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bioavailability and Functionality of Conjugated Fatty Acids in Foods","authors":"M. J.","doi":"10.23880/beba-16000167","DOIUrl":"https://doi.org/10.23880/beba-16000167","url":null,"abstract":"Dietary conjugated fatty acids are associated with heart disease, obesity, diabetes, cancer and others; in addition, many functions of cell membranes are dependent on lipid composition and lipids ingested through the diet can modify this composition and their biochemical activity. Due to the discoveries of their chemical and physiological properties, there is a growing interest in conjugated fatty acids as well as in the properties of their isomers. Conjugated fatty acids (CFAs) are the general term to describe the positional and geometric isomers of polyunsaturated fatty acids with conjugated double bonds, which are separated by a single carbon-carbon bond rather than being separated by a methylene group (CH2). Theoretically, several isomers of conjugated fatty acids are possible, with multiple combinations of numerical, positional and geometric configurations of the conjugation of double bonds, which may present as conjugated linoleic and α-linolenic acids and may have different functionalities in the body.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81217341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multifunctional Nanotherapeutics for Drug-Resistant Breast Cancer","authors":"Song Lou","doi":"10.23880/beba-16000160","DOIUrl":"https://doi.org/10.23880/beba-16000160","url":null,"abstract":"Tumors are inherently resilient and always develop drug-resistance, leading to poor patient therapy effect. With the developing of sophisticated analytical tools, some novel strategy on improving targeting of anti-cancer delivery is developed to better thwart drug-resistance. This report demonstrates a multilayered nano-system to serve as a multifunctional platform for the treatment of drug-resistant breast cancers. This nano-system is composed of a poly (lactic-co-glycolic acid) core, a liposome second layer, and a hyaluronic acid outmost layer. The different types of drug, loaded in different layers, are released in a controlled and sequential manner upon internalization and localization. This recreated the time-staggering effect necessary for maximal efficacy.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81919388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chimeric Antigen Receptor T-Cell Therapy (Car T-Cells) in Solid Tumors, Resistance and Success","authors":"E. Y.","doi":"10.23880/beba-16000163","DOIUrl":"https://doi.org/10.23880/beba-16000163","url":null,"abstract":"CARs are chimeric synthetic antigen receptors that can be introduced into an immune cell to retarget its cytotoxicity toward a specific tumor antigen. CAR T-cells immunotherapy demonstrated significant success in the management of hematologic malignancies. Nevertheless, limited studies are present regarding its efficacy in solid and refractory tumors. It is well known that the major concerns regarding this technique include the risk of relapse and the resistance of tumor cells, in addition to high expenses and limited affordability. Several factors play a crucial role in improving the efficacy of immunotherapy, including tumor mutation burden (TMB), microsatellite instability (MSI), loss of heterozygosity (LOH), the APOBEC Protein Family, tumor microenvironment (TMI), and epigenetics. In this minireview, we address the current and future applications of CAR T-Cells against solid tumors and their measure for factors of resistance and success.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77852807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Protective Effects of Different Types of Yemeni Honey on Hepatorenal Toxicity Induced by Gentamicin on Guinea Pigs","authors":"Al-Awar Msa","doi":"10.23880/beba-16000159","DOIUrl":"https://doi.org/10.23880/beba-16000159","url":null,"abstract":"Aim: This study aimed to investigate the antioxidant properties of different types of Yemeni honey in reducing hepatotoxicity and nephrotoxicity caused by gentamicin in the female guinea pigs. Method and Results: The administration of Osaimi sider honey, Athel honey, Dam Al-Akhawain honey, Salam honey (5 mg/kg orally), Gentamicin (80 mg/kg i.p.), gentamicin+Osaimi sider honey, gentamicin+ Athel honey, gentamicin+ Dam Al-Akhawain honey, and gentamicin+ Salam honey for 7days caused a significant increase in the levels of AST and ALT, and also caused a significant decrease in the levels of total protein and albumin in gentamicin treated groups together with significant elevation in levels of urea and no significant increase in the level of creatinine. However, co-administration of gentamicin with different types of Yemeni honey used in this study ameliorated the harmful effects of gentamicin in most of the tested parameters. Different types of Yemeni honey used in this study have a protective effect on the histological changes of liver and kidney tissues induced either by gentamicin administration. Conclusion: The present study concluded that the use of antioxidants (Yemeni Honey) showed a highly significant protective effect on the functions and tissue of the liver and kidney when they were used as co-treatment. The effects of honey that were found in our experiment are due to the presence of many antioxidant compounds such as flavonoids, ascorbic acid, tocopherols, catalase, and phenolic compounds, that work together to provide a synergistic antioxidant effect, scavenging and eliminating free radicals. But the protective effect of the treatment with sider honey and Dam Al-Akhawain honey had a greater protective effect on the liver and the treatment with Dam Al-Akhawain honey and Athel honey had a greater protective effect on the kidney which was almost similar to the control.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80538095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Distinguish Thyroid Malignant from Benign Alterations Using X-Ray Fluorescence Analysis of Trace Element Contents in Nodular Tissue","authors":"Z. V","doi":"10.23880/beba-16000161","DOIUrl":"https://doi.org/10.23880/beba-16000161","url":null,"abstract":"Introduction: Thyroid benign (TBN) and malignant (TMN) nodules are a common thyroid lesion. The differentiation of TMN often remains a clinical challenge and further improvements of TMN diagnostic accuracy are warranted. Objective: The aim of present study was to evaluate possibilities of using differences in trace elements (TEs) contents in nodular tissue for diagnosis of thyroid malignancy. Methods: Contents of TEs such as bromine (Br), copper (Cu), iron (Fe), iodine (I), rubidium (Rb), strontium (Sr), and zinc (Zn) were prospectively evaluated in nodular tissue of thyroids with TBN (79 patients) and to TMN (41 patients). Measurements were performed using energy-dispersive X-ray fluorescent analysis. Results: It was observed that in TMN tissue the mass fractions of Br, I and Zn were approximately 2.9, 20, and 1.3 times, respectively, lower while the mass fraction of Rb 41% higher than in TBN tissue. Contents of Cu, Fe, and Sr found in the TBN and TMN groups of nodular tissue samples were similar. Conclusions: It was proposed to use the I mass fraction and I/Rb mass fraction ratio in a needle-biopsy of thyroid nodules as a potential tool to diagnose thyroid malignancy. Further studies on larger number of samples are required to confirm our findings and proposals.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88391430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Elevated Levels of Some Intra-Thyroidal Trace Elements with Goiter and Cancer Risk of Female Thyroid","authors":"Z. V","doi":"10.23880/beba-16000164","DOIUrl":"https://doi.org/10.23880/beba-16000164","url":null,"abstract":"Introduction: Advancing age is known to influence the formation of adenomatous goiter and thyroid cancer. An excess or deficiency of specific TEs contents in thyroid can play an important role in goitro- and carcinogenesis of this gland. Objective: This study aimed to assess the variation with age of fifty trace element (TE) contents in normal female thyroid. Methods: Samples of the human thyroid were obtained from randomly selected autopsy specimens of 33 females (European- Caucasian) aged 3.5 to 87 years after a sudden death mainly from trauma. The mass fractions of TEs in normal female thyroids were investigated using neutron activation analysis and inductively coupled plasma mass spectrometry. Tissue samples were divided into two portions. One was used for morphological study while the other was intended for TEs analysis. Results: This work revealed that there is a statistically significant increase in Co, Cs, Fe, La, Pb, Rb, Sb, Se, Sn, Tl, and Zn mass fraction in the normal thyroid of female during a lifespan. Contents of such carcinogenic or potentially carcinogenic TEs as Co, La, Pb, Sb, Sn, and Tl in thyroid of seniors are 5-10 times higher than those in thyroid of girls or young women. Conclusions: From results of our study, a goitrogenic and carcinogenic effect of elevated Co, Cs, Fe, La, Pb, Rb, Sb, Se, Sn, Tl, and Zn levels in the thyroid of elderly females is shown to be a very likely consequence.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77403095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}