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

{"title":"Monitoring Regulatory Compliance within the Pharmaceutical Industry","authors":"Md Moidul Islam, Sarjana Raikwar","doi":"10.2174/0126673371317148240529112603","DOIUrl":"https://doi.org/10.2174/0126673371317148240529112603","url":null,"abstract":"<jats:sec>\u0000<jats:title/>\u0000<jats:p/>\u0000</jats:sec>","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"65 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141388244","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":"Regulation of Nanomaterials and Nanomedicines for Clinical Application","authors":"Razi Ahmed, Vikash Maurya, Anurag Dwivedi, Manoj Kumar Mishra","doi":"10.2174/0126673371276087240129102832","DOIUrl":"https://doi.org/10.2174/0126673371276087240129102832","url":null,"abstract":"\u0000\u0000Treatment of complicated fatal diseases was difficult when nanotechnology was not\u0000more popular. The incorporation of nanomedicine has increased in the last 13 years, even though\u0000regulatory guidelines regarding nanomaterials and nanomedicine weren't sufficient. Hence, it\u0000was tough to decide valid inevitability for the manufacturers, administrators, health professionals,\u0000primary care providers, and rest of the public that could ultimately have a negative impact on\u0000the financing system, research, and development of such items, affecting the approval of the public\u0000and acceptance of nano-products. This review includes coverage across the therapeutic value\u0000of nanomaterials, problems in the regulation, regulatory challenges, synthesis, physicochemical\u0000properties, and clinical application. The hurdles to using nanotechnology, particularly in the\u0000pharmaceutical development of novel medicinal products and respective regulatory issues, are\u0000critically explored, considering the characteristics offered by the nanomaterials.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"18 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140264017","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":"Qualitative Analysis and Anti-oxidant Potential of Ethanolic Extract of\u0000Manilkara zapota (L.) P. Royen Leaves","authors":"Priyanka Sharma, A. Deep, Harish Kumar, Devendar Chaudhary, Neha Thakur, Shubham Batra","doi":"10.2174/0126673371270962240104071232","DOIUrl":"https://doi.org/10.2174/0126673371270962240104071232","url":null,"abstract":"\u0000\u0000The normal metabolic functioning of aerobic cells is related to free\u0000radical formation. The oxygen utilized in the cell growth gives rise to a number of oxygen free\u0000radicals. Further, these oxygen free radicals interact with lipidic molecules to produce hydroxyperoxides\u0000and various other peroxides also, radicals like superoxide, hydroxyls, and lipoid\u0000peroxides, which lead to cytotoxicity due to their interaction with biological systems. The uncontrolled\u0000generation of free radicals may lead to various diseases and disorders like prostate\u0000cancer, coronary heart disease and also ageing. The therapeutic potential of the plant M. zapota\u0000has been demonstrated in various diseases, such as cancers (e.g., breast, prostate, cervical, and\u0000hepatocellular cancer), diabetes mellitus, arthritis, bacterial infections, and gastrointestinal disorders\u0000(e.g., diarrhea and ulcers) and many medical conditions. The main phytocomponents of\u0000this plant are polyphenols, alkaloids, glycosides, flavonoids, saponins, triterpenoids, carbohydrates,\u0000tannins, and sterols.\u0000\u0000\u0000\u0000The objective of this study is to investigate qualitative analysis and anti-oxidant potential\u0000of ethanolic extract of Manilkara zapota (L.) P. Royen Leaves. In demand to minimize\u0000the damage caused by free radicals. It is very essential to develop such antioxidants which protect\u0000the body from the effect of free radicals and also do not cause much harm to the human\u0000body. The main phytocomponents of the plant are polyphenols, alkaloids, glycosides, flavonoids,\u0000saponins, triterpenoids, carbohydrates, tannins and sterols which are responsible for antioxidant\u0000activity.\u0000\u0000\u0000\u0000Phytochemical screening methods, Gas chromatography–mass spectrometry\u0000(GC-MS), Fourier transform infrared (FTIR), and Hydrogen Peroxide scavenging assay\u0000for analysis of an ethanolic extract of plant leaves.\u0000\u0000\u0000\u0000Antioxidant activity was determined by a hydrogen peroxide assay.\u0000Plant extract was examined using phytochemical screening, GC-MS analysis, and FTIR spectra.\u0000The plant extract showed hydrogen peroxide scavenging activity (IC50 = 16.45 μg/ml)\u0000compared to the IC50 values of standard ascorbic acid (IC50 = 9.079 μg/ml).\u0000\u0000\u0000\u0000The present study concluded the antioxidant and phytochemical assessment of the\u0000ethanolic extract of the leaves of Manilkara zapota. The results of the present research study\u0000demonstrated that the antioxidant activity of the plant extract was strong as compared to ascorbic\u0000acid.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"37 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140487649","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 Current Regulatory Environment for Software Used in Medical Devices: A Need for Refined International Strategies","authors":"N. S. Patil, Animesh Ranjan, Gaurav, Amandeep Singh","doi":"10.2174/0126673371279532240102113651","DOIUrl":"https://doi.org/10.2174/0126673371279532240102113651","url":null,"abstract":"\u0000\u0000In the fast-evolving landscape of healthcare technology, Software as a Medical Device\u0000(SaMD) has emerged as a transformative force, redefining how medical functionalities are delivered\u0000and accessed. From diagnostic algorithms to treatment monitoring applications, SaMD\u0000has ushered in a new era of innovation and patient care[1]. As this field continues to burgeon,\u0000regulatory frameworks play a pivotal role in ensuring the safety, efficacy, and reliability of these\u0000digital health solutions[2]. In this editorial, we delve into the dynamic regulatory landscape\u0000of SaMD in both the BRICS (Brazil, Russia, India, China, and South Africa) nations and the United States (US), exploring the\u0000nuances and challenges that underscore the need for more refined strategies. By examining the regulatory intricacies and aligning\u0000them with technological advancements, we aim to shed light on the imperative of adaptive regulatory approaches that can\u0000harness the full potential of SaMD while safeguarding public health. A remarkable role of \"software as a medical device\"\u0000(SaMD) in contemporary healthcare software that is intended to be used for medical purposes but is not a component of a\u0000hardware medical device is referred to as \"software as a medical device\" (SaMD)[3]. SaMD is essential to contemporary\u0000healthcare since it makes it possible to use software applications for a variety of medical functions, diagnoses, treatments, and\u0000monitoring [4].\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"39 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139602348","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 comparative study on approval of follow-on version of Sevelamer Carbonate and Glatiramer Acetate (GA) in US, EU","authors":"V. Shukla, Nisha Sankhwar","doi":"10.2174/2667337109666230428094012","DOIUrl":"https://doi.org/10.2174/2667337109666230428094012","url":null,"abstract":"\u0000\u0000Many non-biological drugs, different in terms of their structure and mode of action, pharmacological classification, and therapeutic indication, have a common factor of structural complexity and are grouped as non-biological complex drugs (NBCDs). When an innovator drug nears the time of off-patent, different manufacturers attempt to produce its subsequent version, so the patients will have a cost-effective therapeutic equivalent. Since the innovator molecule is complex, its follow-on drug can be called its true generic version, if its bioavailability, bioequivalence and therapeutic equivalence to the innovator drug are demonstrated. However, it is observed that a case-to-case basis approach is implemented by European Medicines Agency (EMA) and Food and Drug Administration, US (USFDA) in the approval of such drugs and there is no uniformity observed between the two. \u0000In this study, an attempt is made to study the complexity of molecules compare and understand the data requirements, and procedures adopted for the review and approval of such complex products. Therefore, drug sevelamer carbonate and glatiramer acetate are selected for the study. A methodical approach was followed. European assessment reports and drug approvals available in the orange book database of the former two regulatory agencies were studied. It is observed that the generic version of glatiramer acetate is approved as an abbreviated new drug application (ANDA) by Food and Drug Administration whereas the same was approved as the hybrid application by European Medicines Agency requiring the applicant to generate and submit more data. Thus, harmonization of the regulatory requirements for the approval of follow-on versions of such complex drugs is essential for better understanding, predictability of the regulatory process, and acceleration of the drug approval process, in the interest of patients. This will help the faster access of the drugs to the patients and allow interchangeability of the innovator drugs with its cost-effective generic version.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"96 1-3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83349342","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":"Misery of Long Haulers of COVID-19 - A Review","authors":"Pragi, Varun Kumar, Deepak Garg","doi":"10.2174/2667337109666230301145233","DOIUrl":"https://doi.org/10.2174/2667337109666230301145233","url":null,"abstract":"\u0000\u0000Early in December 2019, Wuhan City, Hubei Province, China, had an epidemic of the Coronavirus illness 2019 (COVID-19), which was brought on by a brand-new severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). The epidemic was deemed a Public Health Emergency of International Concern by the World Health Organization on January 30, 2020. Many governments have implemented a range of control measures as a result of perceived illness risk.\u0000\u0000\u0000\u0000The pandemic revealed that COVID-19 affects a variety of organs in addition to the lungs, including the heart and brain, raising the risk of long-term health consequences. The illness can affect someone's health even after recovery in a variety of ways. The long-term effects of COVID-19 on locals are still being researched. The objective is to compile knowledge regarding the virus and the present Post pandemic complications in Long Haulers.\u0000\u0000\u0000\u0000We reviewed the body of publicly available literature. To discover publications published between December 2019 and October 2020, we conducted a systematic search utilizing the keywords in online databases such as Pub Med, Scopus, Science Direct, Up to Date, and Web of Science. The review includes peer-reviewed original publications published that matched the qualifying requirements.\u0000\u0000\u0000\u0000Although the majority of patients recovered quickly after receiving COVID-19, the possibility of long-term issues induced by COVID-19 necessitates the search for and research of its late consequences. This article aims to provide a comprehensive assessment of COVID-19 late complications in order to determine how prevalent these symptoms are and who is most likely to be impacted.\u0000\u0000\u0000\u0000There are a number of difficulties with the COVID-19 pandemic that has yet to be resolved. Review of the literature reported several long-lasting clinical problems that affect different phases of health, including chronic fatigue, reduced physical capacity, muscle weakness, increased depression, anxiety, post-traumatic stress disorder and sleep problems. A complete turndown in quality of life has been observed even one year after major Coronavirus outbreaks. \u0000The pandemic revealed that COVID-19 affects a variety of organs in addition to the lungs, including the heart and brain, raising the risk of long-term health consequences even after years making them to be “Long Haulers”.\u0000The causal agent, pathogenesis, immunological responses, epidemiology, diagnosis, therapy, and management of the disease, as well as control and preventive efforts, are all included in this review of the literature.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88796944","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":"Artificial Intelligence In Drug Regulatory Submissions In India","authors":"V. Shukla, Manvi Mittal","doi":"10.2174/2667337109666230209152153","DOIUrl":"https://doi.org/10.2174/2667337109666230209152153","url":null,"abstract":"\u0000\u0000Regulatory affairs are one of the most crucial connections between the pharmaceutical company and the other stakeholder’s or regulatory agencies such as FDA, EMA, etc. Strategies in drug approval and marketing to assure the quality, safety, and efficacy of the drug follow the guidelines and laws stated under the drug and cosmetic act 1940 and rules 1945. Their primary responsibility is to keep the company in compliance with changing guidelines, which necessitates constant monitoring of the most recent industry updates. Drug regulation is a complex process as every country has its own set of documentation that must be done while regulatory submissions. From drug development and drug approval to drug commercialisation, there is a large amount of documentation that must be completed with accuracy, which can be challenging for the professional to complete, therefore, this leads to the introduction of the concept of big data that can be incorporated which will map the regulations according to 5vs model of big data. Thus, to make it more efficient, we can work big data with artificial intelligence to ease the process using natural language processing. This concept will map all the rules and guidelines together and make a cluster of similar rules together. Now, users can use the tool to locate the data of interest in a single site in a more comprised universal language that can be accessed by any professional to complete the task in the given time schedule.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"41 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78482747","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":"Novel Approaches of Self Emulsifying Drug Delivery Systems and recent patents: A Comprehensive Review","authors":"A. Deep, Rimmy, S. Tahlan","doi":"10.2174/2667337109666230120095944","DOIUrl":"https://doi.org/10.2174/2667337109666230120095944","url":null,"abstract":"\u0000\u0000The main aim of the current work is to set up a revolutionary Self Nano-emulsifying drug delivery system to improve the necessary bio-availability and to boost clinical efficacy when administered orally.\u0000\u0000\u0000\u0000This study's main target is to develop a novel self-nano emulsifying drug delivery system (SNEDDS) for orally administered, poorly water-soluble medicines. SNEDDS is designed to intensify weakly water dissolvable or lipophilic drugs. SNEDDS is designed to intensify weakly water dissolvable or lipophilic drugs. It contains a micro- or nano-emulsion of oil carrying medicament that spontaneously agitates an aqueous medium. For enhancing the solubility of lipophilic medicines, SNEDDS is the most significantly used in biopharmaceutics classification system [BCS class] II and IV pharmaceuticals.\u0000\u0000\u0000\u0000The improved rate of dissolution and prevention of interfacial tension are clearly demonstrated by SNEDDS. In aqueous mediums, such as gastrointestinal fluid, SNEDDS produces a stable emulsion after dilution.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85246178","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":"Combating childhood cancer: Paediatric patients living with Neuroblastoma - Regulatory ramifications and roadblocks","authors":"Manfred Kurz","doi":"10.2174/2667337109666221207154414","DOIUrl":"https://doi.org/10.2174/2667337109666221207154414","url":null,"abstract":"\u0000\u0000This paper relates to Neuroblastoma (NBL), a rare, solid cancer affecting children and aims to describe regulatory obligations to adhere to during development, marketing authorisation application (MAA) and post-authorisation stage. The focus is on European Union (EU) paediatric legislation, although essential US Food and Drug Administration (FDA) elements are briefly outlined. Practical regulatory aspects and reporting requirements, players in the therapeutic area as well as clinical management are described. The feasibility and limitations of future harmonised clinical development are pointed out.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84162199","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":"Safety of Soluplus® in Pediatrics","authors":"G. Schmitt","doi":"10.2174/2667337109666221116092457","DOIUrl":"https://doi.org/10.2174/2667337109666221116092457","url":null,"abstract":"\u0000\u0000This paper provides information on the risk and acceptability of the polymeric solubilizer Soluplus® as an excipient in pediatric formulations. The assessment was performed based on safety data available from the manufacturer and publicly available data sources. Soluplus® is virtually non-toxic in rats and dogs after oral administration, consistent with its negligible systemic exposure. The non-toxic dose levels established in animals translate into a substantial Human Equivalent Dose (>300 mg/kg). Clinical safety data in adult subjects further support the presumed safe use of Soluplus® in pediatric clinical formulations. Based on existing data, additional toxicology studies in juvenile animals are not warranted. Overall, the use of Soluplus® as an excipient in pediatric clinical formulations in 300 mg or 30 mg/kg can be considered reasonably safe.\u0000","PeriodicalId":72255,"journal":{"name":"Applied drug research, clinical trials and regulatory affairs","volume":"75 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79178892","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}