Applied drug research, clinical trials and regulatory affairs最新文献

{"title":"Review of Modified Oral Solid Drug Delivery System and Recent Active Patents","authors":"S. Gaikwad, Shrikant K. Ainor, Narayan B. Lande, Salunkhe","doi":"10.2174/2667337109666221108141059","DOIUrl":"https://doi.org/10.2174/2667337109666221108141059","url":null,"abstract":"\u0000\u0000A tablet is a solid dosage form containing active pharmaceutical ingredients (API) and various excipients. Different procedures, such as direct compression of powder mixtures, and dry and wet granulation technologies, are used to create distinct types of tablets. Tablet development is aided by technological advancements in the form of modified-release tablets.\u0000\u0000\u0000\u0000The modified release dosage form can be manufactured to obtain a specific pharmaceutical profile, the specific site of action and reduce the number of dose administrations using a variety of coating technologies. For modified released drug delivery, various sorts of patents are explored. The review's primary goal is to provide information on modified release formulations, formulation methodologies, current active patents based on modified release, and tablet coating technologies.\u0000\u0000\u0000\u0000The tablet is a common and convenient pharmaceutical dosage form. Recently, modified release drug administration has largely supplanted traditional tablet drug delivery technologies. The chrono pharmaceutical drug delivery can also involve modified drug delivery. Modified release tablets are used to boost the therapeutic impact of medicine by targeting the location of action on the illness condition. Modified-release tablets are very handy, easy to create, cost-effective, and do not require high-cost equipment, and they are gaining in popularity these days. Patents for modified-release tablet dosage formulations that are currently active were also discussed.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84862140","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":"Preliminary results of the combined BlockACE2® Prevention and BlockACE2® functional food scheme for the prevention of COVID-19 in working population. Clinical trial , controlled, randomized, triple-blind, phase II.","authors":"Beatriz H. Aristizabal-B, Clara I. Aristizabal-B, Bernardo Agudelo-J, Luis Miguel Gomez- O, Luz Elena Cano-R, Beatriz Estella Lopez-M, Juan Fernando Saldarriaga-F, Olga L. Rincon-C","doi":"10.2174/2667337109666220329180338","DOIUrl":"https://doi.org/10.2174/2667337109666220329180338","url":null,"abstract":"\u0000\u0000It is urgent to adopt public health measures and implement a preventive approach, its contagiousness and alleviate severe COVID-19, by reducing excessive inflammation.\u0000\u0000\u0000\u0000To establish the efficacy and safety of the combined use of BlockACE2® oropharyngeal spray, and emulsion, in comparison with placebo on the reduction of the risk of infection by COVID-19, expressed in the negative result of immunoglobulins for COVID-19.\u0000\u0000\u0000\u0000The clinical study includes 156 participants, ended with 125 adherent participants, 69 in the placebo group and 56 in the BlockACE2 group, with follow-up for 45 days. IgM seroconversion and confirmed with a RT-PCR test for COVID-19 were analyzed.\u0000\u0000\u0000\u0000the cases diagnosed in the placebo group were 5/64 = 0.078% and in the BlockACE2 group 1/55 = 0.018%. The practice of evidence-based medicine considers the randomized clinical trial as the standard to assess the efficacy of health technologies and recommends that decisions be made, with therapeutic options of proven efficacy. The recommended way to present the results of a randomized clinical trial and other types of study should include Relative risk reduction (RRR), Absolute Risk Reduction (RAR) and Necessary number of patients to treat to reduce an event (NNT). This way of presenting the results quantifies the effort to be made to achieve the reduction of an unfavorable event. Relative risk (RR) was 0.25, with a 95% CI (0.03 to 2.05) not statistically significant due to relatively small sample; however, other statistical measures from the clinical evidence were used, such as the Absolute Power, which was 0.753, which means that BlockACE2 could reduce the risk of coronavirus disease of any severity by 75.3%. The number needed to treat (NNT) is 18.31 people,\u0000\u0000\u0000\u0000Due to its characteristics as a food that has no indication for the treatment of diseases as a medicine, or as a nutritional supplement, it requires a rigorous stance to guarantee the validity of the findings from the conduct of the research protocol. In this way, a clinically relevant finding, although “not statistically significant”, appears as a signal to scale models of clinical experimentation in the area, for new indications or new presentations. These natural support products could improve the immune conditions to neutralize the entry of the virus into the body and stimulate the cellular immune response to control the aggression of the virus, support and help control the pandemic in an efficient way.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"506 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72433921","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":"Building and implementing a quality assurance/quality improvement program for clinical research.","authors":"Reva Bruns,&nbsp;Marietta Barton-Baxter,&nbsp;Roxane Poskin,&nbsp;Philip A Kern,&nbsp;William W Stoops","doi":"10.2174/2667337109666220615125134","DOIUrl":"10.2174/2667337109666220615125134","url":null,"abstract":"<p><strong>Background: </strong>A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices.</p><p><strong>Objective: </strong>One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical and safe.</p><p><strong>Methods: </strong>The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program's goal was to improve research design quality and from the start of the project, \"find it, fix it\", leading to improved PI education, without being viewed as punitive.</p><p><strong>Results: </strong>Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth.</p><p><strong>Conclusion: </strong>A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational and well accepted by all clinical research stakeholders.</p>","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"9 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9815204/pdf/nihms-1805204.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9475379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A note on robotics and artificial intelligence in pharmacy","authors":"Sankha Bhattacharya","doi":"10.2174/2667337108666211206151551","DOIUrl":"https://doi.org/10.2174/2667337108666211206151551","url":null,"abstract":"\u0000\u0000Artificial intelligence and robotics are two of the hottest and most recent technologies to\u0000emerge from the world of science. There is tremendous potential for these technologies to solve a\u0000wide range of pharmaceutical problems, including the reduction of the enormous amounts of money and time invested in the drug discovery and development process, technical solutions related to\u0000the quality of drug products, and an increase in the demand for pharmaceuticals. Nanorobotics is a\u0000new subfield that has emerged from the field of robotics itself. This technique makes use of robots\u0000that are as small as nano- or micron-sized to diagnose diseases and deliver drugs to the targeted organ, tissue, or cell. These techniques, as well as their various applications in the pharmacy sector,\u0000are extensively discussed throughout this article. Internationally renowned pharmaceutical companies are collaborating with Artificial Intelligence behemoths in order to revolutionise the discovery\u0000and development process of potential drug molecules and to ensure the highest possible quality in\u0000their products.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83999020","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":"Clinical and Regulatory Status of Silymarin","authors":"Tanya Ralli, V. Kalaiselvan, Ritu Tiwari, S. Shukla, Kanchan Kholi","doi":"10.2174/2667337108666211112153807","DOIUrl":"https://doi.org/10.2174/2667337108666211112153807","url":null,"abstract":"\u0000\u0000Silymarin is a mixture of 9 different active flavanolignans extracted from the seeds of the milk thistle (Silybum marianum) plant. It has been extensively used by local people and medicinal practitioners in European countries from around 2,000 years for the treatment of liver and biliary-related disorders.\u0000\u0000\u0000\u0000This review article documents and critically assesses, for the first time, up to date the regulatory status of the silymarin extract for the treatment of hepatic and other diseases.\u0000\u0000\u0000\u0000Information was collected systematically from electronic scientific databases including Google Scholar, Science Direct, PubMed, Web of Science, ACS Publications, Elsevier, SciFinder, and Wiley Online Library, as well as other literature sources (e.g., books). Additionally, various regulatory authority websites have been searched for exploring the data.\u0000\u0000\u0000\u0000 Silymarin has been approved in different doses for the treatment or adjuvant therapy for liver disorders by the regulatory authorities of different countries. But, silymarin has still been used as a dietary supplement in the US, despite its high sales. The potential of silymarin to be approved for various other indications has been proved by assessing its efficacy in human patients. In addition to efficacy, it is found to be safe and well-tolerated.\u0000\u0000\u0000\u0000Phytochemical and pharmacological studies have demonstrated that silymarin is an important medicinal herb with prominent bioactivities. Thus, there is a need to conduct clinical trials in a larger number of patients to get approval for use in diseases like metabolic syndrome, diabetes mellitus, cancer, and many more.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85365704","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":"Intellectual Property Rights and computer applications for pharmaceutical research and development","authors":"Sankha Bhattacharya, Dnyanesh Saindane","doi":"10.2174/2667337108666211103105845","DOIUrl":"https://doi.org/10.2174/2667337108666211103105845","url":null,"abstract":"\u0000\u0000Intellectual property rights (IPR) are intellectual privileges that allow authors and inventors to defend their original inventions from misuse or theft. With the assistance of algorithms, clinical science has taken on a different level in recent years. Various advanced tools can be used to investigate pharmacokinetics profiling, in silico experiments, receptor simulations, drug synergistic effects, and so on. Computational scientists are making continuous efforts to figure out how to connect business models in pharmacology. However, software theft and security rights remain major concerns for all. In order to avoid such violations, IPR compliance for R&D as well as promoting machine applications is critical. This compilation will illustrate diverse software concepts, the latest patent data structures, copyright management laws for software, trade secrets, compliance rights, software patenting and contracts, artificial technology priorities and problems, licenses, and case studies relating to IPR violations in pharmaceutical and other fields.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75458989","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":"Pediatric Drug-Related Problems in an Indian Tertiary Care Hospital","authors":"Q. Jahan, K. Pallavi, R. Hamshika, V. Talla, J. Rao, S. Pattnaik","doi":"10.2174/2667337108666211029122255","DOIUrl":"https://doi.org/10.2174/2667337108666211029122255","url":null,"abstract":"\u0000\u0000 Improper drug usages expose patients to drug-related problems (DRPs) and can be the cause of patient morbidity and even mortality, especially frequent in hospitalized patients and pediatric groups. \u0000\u0000\u0000\u0000\u0000The objective of the present study was to identify and assess the drug-related problems in the pediatric department of tertiary care hospitals. \u0000\u0000\u0000\u0000\u0000The cross-sectional, observational study was carried out for six months included pediatric in-patients of age ≤15 years of either gender in pediatric units of tertiary care hospitals of India. The enrolled pediatric patients were observed for any drug-related problem that were further recorded and classified using the DRP registration format taken from Cipolle et al. The assessment of therapy was done by using positional statements from standard organizations and guidelines. Main outcome measure: Incidences of drug-related problems and their assessment and root cause analysis. \u0000\u0000\u0000\u0000\u0000 A total of 970 DRPs were identified in 296 patients, with an overall incidence of 49.3%. The incidence of DRPs was maximum in the age group of 2-12 years of children (51.2%). Patients who took six or more drugs were around eight (OR:8.41 , 95% CI: 5.22 to 13.55) times more likely to have DRPs compared to those patients who took less than six drugs. The incidences of DRPs were more in patients who were hospitalized for ≥ 7 days. \u0000\u0000\u0000\u0000\u0000The present study revealed significantly higher incidences of DRPs in hospitalized pediatric patients necessitating the involvement of clinical pharmacists in the pediatric department of tertiary care hospitals. \u0000\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90308979","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":"Regulations and Reimbursement of Digital Therapeutics: A Review of Current Global Practices and Future Prospects","authors":"A. Dang, Dimple Dang, P. Rane","doi":"10.2174/2667337108666211018101106","DOIUrl":"https://doi.org/10.2174/2667337108666211018101106","url":null,"abstract":"\u0000\u0000The ever-increasing use of digital technologies is rapidly changing the face of modern healthcare delivery. Healthcare systems are embracing digital health solutions to improve patient outcomes, enhance healthcare delivery, and reduce costs. Digital therapeutics (DTx) are now a popular category of digital health solutions aimed at preventing, managing, or treating medical disorders. These evidence-based technologies/products either complement a conventional therapy or are prescribed as stand-alone treatments for a range of conditions, including chronic diseases and mental health disorders. Many pharmaceutical companies and healthcare start-ups are developing DTx products for different health conditions. Despite similarities between DTx and conventional medicines, DTx products are not covered under reimbursement at present in many countries. There are no uniform regulations for DTx prescription and reimbursement. This review aims to analyse the current DTx scenario, particularly highlighting the regulatory aspect and reimbursement of DTx products globally.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91250376","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":"Lessons Learned from the COVID-19 Pandemic","authors":"S. Abouchacra, M. Yaman, S. Nair","doi":"10.2174/2213476x07999200918180556","DOIUrl":"https://doi.org/10.2174/2213476x07999200918180556","url":null,"abstract":"\u0000\u0000The COVID19 pandemic has devastated the entire globe with an astounding\u0000death toll and various forms of human suffering worldwide. In its wake, it has uncovered serious\u0000flaws and shortcomings in healthcare systems and beyond.\u0000\u0000\u0000\u0000The objective of this perspective is to highlight the lessons learned from the catastrophic\u0000pandemic and propose recommendations for optimal future preparedness.\u0000\u0000\u0000\u0000Current literature was reviewed to identify common and serious challenges faced during\u0000and in the process of instituting solutions for addressing the COVID19 pandemic.\u0000\u0000\u0000\u0000The uncovered challenges appear to be similar in various countries across the globe, clearly\u0000demonstrating universal patterns in lack of preparedness. This spanned critical shortage in healthcare\u0000facilities, equipment, consumables and staffing along with technological gaps needs to keep\u0000up with the emerging needs. There are also major obstacles impeding the rapid development and\u0000implementation of diagnostics and therapeutics, and in addition, public awareness and international\u0000collaborations are immature to effectively handle the crisis.\u0000\u0000\u0000\u0000Fortunately many of these shortfalls lend themselves to intervention, however country-\u0000specific strategies must be preplanned with proactive readiness for rapid implementation during\u0000crisis situations. These go beyond readiness with physical space, essential equipment and consumables,\u0000and further involve proper capacity and manpower planning as well as local and global coordinated\u0000communication and cooperative collaborations. Moreover, self-sufficiency and sustainability\u0000are key to ensure the continuous provision of essential supplies and other needs. COVID19 has\u0000taught us that the world could never be too ready or prepared for such unexpected future events.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91289469","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}