{"title":"Bioequivalence Study Comparing a Generic and Innovator Drug of Rosuvastatin 20 mg","authors":"Dewi Ou","doi":"10.23880/beba-16000189","DOIUrl":"https://doi.org/10.23880/beba-16000189","url":null,"abstract":"The bioequivalence study was conducted to compare the bioavailability of two rosuvastatin 20 mg film-coated tablet formulations (test and reference formulation). This study was an open-label, randomized, single-dose, two-periods, twotreatments, and crossover study which included 32 healthy adult male and female subjects under fasting conditions. Each of the two study periods was separated by a 7 days washout period. A single oral dose of test or reference drug was administered to the subject in each period based on the randomization scheme. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were the area under the plasma concentration-time curve from time zero to 72 h (AUC0-72h), area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (Tmax), and the elimination half-life (T1/2). The geometric mean ratio (GMR) and 90% Confidence Interval (90% CI) for AUC0-72h and Cmax of test/reference drug for rosuvastatin were 97.05 % (89.07%– 105.74%) and 101.15% (89.53%– 114.26%). Since the 90% CI with α 0.05% for AUC0-72h and Cmax of rosuvastatin were within the standard bioequivalence range (80.00– 125.00%), it was concluded that the two rosuvastatin film-coated tablets (test and reference drug) were bioequivalence in terms of the rate and extent of absorption.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"37 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82745564","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 – Challenges and Advances in Drug Targeting","authors":"V. M.","doi":"10.23880/beba-16000186","DOIUrl":"https://doi.org/10.23880/beba-16000186","url":null,"abstract":"It has been a very challenging task in drug development to handle bioavailability of drug molecules during targeting. Foremost challenges include the time span involved apart from various complexities, wrong methods or failure in outcome, increasing manual and financial requirements to be managed in the drug discovery process. Among this bioavailability is one of the biggest challenges handled to successfully identify druggability in a molecule. Various methods of administration and targeting has been used including co-crystallization, micro emulsion, micellar solubilization and other traditionally which has also expanded to other methods as morphous solid dispersion, liposomes, and complexions. To enable precision in availability of drug molecule at the targeted site. There has been an increase in bioavailability of potential drugs. This review comprehensively determines challenges and methods used in drug targeting based on their bioavailability.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81683463","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":"Evaluation of the Participation of Phenolic Compounds Naturally Present in Food in Stimulating the Health of the Organism","authors":"Mancini-Filho J","doi":"10.23880/beba-16000187","DOIUrl":"https://doi.org/10.23880/beba-16000187","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"119 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76071059","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":"A Mini Review on Bioequivalence & the Bioavailability Study on Anticancer Drugs","authors":"Behera A","doi":"10.23880/beba-16000188","DOIUrl":"https://doi.org/10.23880/beba-16000188","url":null,"abstract":"Bioavailability has been one of the most important properties for the formulation to be an effective. The poor oral bioavailability and solubility of several anti-cancer drugs has challenged the scientists all over the world to think differently than the traditional drug delivery system. Recently, the use of natural polymer has been increased to increase the bioavailability of these drugs. Casein polymer has shown to be promising in increasing the bioavailability of the anticancer drugs due to its amphiphilic nature which can bind both hydrophilic and hydrophobic drugs. Due to the nature of the casein it has drawn the attention of the scientists all over the world. In this review, we have focused on the work of various scientists in increasing the oral bioavailability of poorly bioavailable anticancer drugs.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81245427","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":"Covid-19 Vaccinations and Menstrual Cycle Alteration","authors":"Hussain S","doi":"10.23880/beba-16000182","DOIUrl":"https://doi.org/10.23880/beba-16000182","url":null,"abstract":"The rapid development of safe and effective vaccines against Coronavirus Disease 2019 (COVID-19) has been a triumph of medical sciences, but vaccines only work if people take them. COVID-19 vaccination may be associated with change in menstrual cycle length following vaccination. Although there is extensive evidence that COVID-19 vaccination does not affect fertility, misinformation that it could has been a major source of vaccine hesitancy among young women. As the vaccination program was rolled out to younger age groups, some people noticed menstrual changes after COVID-19 vaccination, and many members of the public found these reports concerning. Research was needed to generate robust data to inform healthcare professionals and the public about these potential side effects. Menstrual changes have been reported in association with a variety of vaccines, including those against pathogens other than severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), so the aim of this work is to describe SARS-CoV-2 infection and the menstrual cycle changes because of it.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72786366","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":"Determination of Caffeine and Chlorogenic Acid (CGA) in the Methanolic Extracts Coffee (C. arabica. L) To seeds and peels (Unroasted and Roasted) Cultivars Grown in Yemen by High Performance Liquid Chromatography (HPLC)","authors":"Ali Sa","doi":"10.23880/beba-16000180","DOIUrl":"https://doi.org/10.23880/beba-16000180","url":null,"abstract":"In this study methanolic extract of one plant namely Arabic coffee, were screened for the presence of analysis Constituents and tested for their of liquid chromatographic separation (HPLC). The quantitative HPLC analysis revealed the results showed presence of Caffeine, chlorogenic acid (CGA) is the concentration of the contents Seeds, peels (unroasted) samples is higher than their contents in the Seeds, and peels (roasted) samples. The highest concentration of Caffeine was 5,334 % in unroasted Arabica coffee peels (Udaini) in Ibb (Kafr) region, while the highest value of chlorogenic acid was 68,460% in unroasted Arabica coffee peels (Tufahi) in Ibb (Kafr). The highest concentration of Caffeine was 9,948% in unroasted Arabic coffee seeds (Udaini) in Ibb (Kafr) region, while the highest concentration of chlorogenic acid was 97,280% in unroasted Arabic coffee seeds (Udaini) in Ibb (Kafr) region. The highest concentration of Caffeine was 1,964 % in roasted Arabica coffee peels (Udaini) in Ibb (Kafr) region, while the highest value of chlorogenic acid was 26,260% in roasted Arabica coffee peels (Bura’ai.) in Sana'a (Haraz). The highest concentration of Caffeine was 2,324% in roasted Arabic coffee seeds (Udaini) in Al- Mahweet (Hufash) region, while the highest concentration of chlorogenic acid was 47,09% in roasted Arabic coffee seeds (Dawairi) in Al- Mahweet (Hufash).","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"123 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85656018","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":"Therapeutic Monitoring-Guided Dosing of Factor Viii in Hemophilia A: From Pharmacodynamics and Pharmacokinetics toward Precision Therapy","authors":"Fortuna A","doi":"10.23880/beba-16000185","DOIUrl":"https://doi.org/10.23880/beba-16000185","url":null,"abstract":"Hemophilia is a rare hypocoagulation disorder that, depending on the lacking coagulation cascade factor, has different denominations. This review focuses on Hemophilia A (HA), particularly on the FVIII concentrates that are available in clinical practice to replace the scarce levels of FVIII observed in these patients. In fact, pharmacological responses are strongly heterogenic namely due to disease evolution and FVIII concentrates pharmacokinetic profiles. Therefore, therapeutic drug monitoring (TDM) is essential to maximize FVIII effectiveness and decrease adverse event rates. We provide a critical overview of current FVIII concentrates their mechanistic and pharmacokinetic differences as well as the factors that determine those profiles. Precision dosing through therapeutic drug monitoring is expanding and is essential in populations with altered pharmacokinetics and/or pharmacodynamics. However, there is still a need for studies correlating pharmacokinetics and patient outcomes. Herein, a pharmacokinetic-based optimization of FVIII therapy was revised and in deeply explained hot it can be successfully applied in clinical practice.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"655 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76841111","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":"Herceptin- A Revolutionary Tool among Personalized or Customized Medicines","authors":"Anju Pg","doi":"10.23880/beba-16000192","DOIUrl":"https://doi.org/10.23880/beba-16000192","url":null,"abstract":"Our current medicinal practices are based on population averages. Medicines discovered in one research centre of a particular country and tested on animals and a broad population available there, are used for the treatment of worldwide population. Medicines are applying based on statistical averages gained from their randomized clinical trials. The drugs available in the world markets are only effective in 50% of the total population. Rest of them are taking medicines like placebo, means they do not produce any effects actually. It is due to the genetic differences. We all are different in every aspect. Our choices of food, our cloths, our dreams, ambitions, rituals, and cultures everything is different. But medical system prescribes drugs based on “one size fits to all”. How can that be sensible? Here comes the importance of personalized medicine. Personalized medicine or precise medicine (PM) is a newer approach of pharmacogenomics under progression. It is actually a customized kind of medicine meant for individual patients according to their genetic makeup. For that we thoroughly understand the patient details not only age and sex but in a detailed way including their genetical variations. So we can understand their drug responsiveness as early as possible. That’s why precise or personalised medicines are also called as genomic medicines. And it will also eliminate the time, cost and failures in the clinical trials which are serious issues that developing countries currently facing.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78199849","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":"Level of Awareness & Attentiveness Associated to Novel Corona Virus (Covid-19) among People of Pakistan","authors":"S. Alam","doi":"10.23880/beba-16000183","DOIUrl":"https://doi.org/10.23880/beba-16000183","url":null,"abstract":"Background: Corona viruses are huge family of viruses named for the crown-like spikes on their surface. There are seven CoV viruses which will infect humans, including the “2019 Novel Corona virus” (the infection right now making features), SARS and MERS.. Symptoms include fever, breathlessness, and coughing. The illness spreads through animals and shut contact with people that have already been infected currently the virus is spreading from person to person in China as many recent cases don't seem to be related to animal markets. Method: A cross sectional investigation about the attention of corona virus (CoV), its symptoms, diagnosis and treatment was directed in several groups of individuals i.e, literate and illiterate people of Pakistan. Data was collected by means of survey based questionnaire which was prepared by the pharmacy students of Jinnah University for Women. Result: According to demographic data obtained by the cross sectional investigation about the attention of corona virus in Pakistan which was conducted among literate and illiterate people (18-25 of age).Out of which 47.9% were medical students, among these people 92.6% knew about corona virus and 97.5% people knew about its person to person transmission, and 58.8% understand its symptoms in keeping with this survey only 23.5% people knew the treatment, 76.5% people didn’t even understand the diagnosis of corona virus. Conclusion: The motivation behind this study was to assemble the information about the extent of control of corona virus with improving knowledge awareness of CoV (COVID-19) to raised inform patients about this life threatening disease in health care systems.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"172 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77986551","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":"Updates in Gastroenterology: Acotiamide for Treatment of Functional Dyspepsia","authors":"Bhalla A","doi":"10.23880/beba-16000195","DOIUrl":"https://doi.org/10.23880/beba-16000195","url":null,"abstract":"Functional dyspepsia (FD) comprises of two types, the postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). Acotiamide is a new prokinetic agent that acts by increased release of acetylcholine and is used in the treatment of FD-postprandial distress syndrome (FD-PDS). The drug initially launched in Japan is the world’s first approved treatment for FD. It exerts its activity via muscarinic receptor inhibition, which enhances acetylcholine (ACh) release, and via inhibition of acetylcholinesterase (AChE) activity in the stomach. It increases the availability of ACh on postsynaptic receptors in the enteric nervous system. The gastroprokinetic activity of acotiamide does not cause prolongation of the QT interval. Long-term studies of 48 weeks have shown a favorable clinical course with acotiamide in FD.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85869741","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}