Applied Drug Research, Clinical Trials and Regulatory Affairs
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Published By Bentham Science Publishers Ltd.

2667-3371

Author(s):  
Sankha Bhattacharya

: Artificial intelligence and robotics are two of the hottest and most recent technologies to emerge from the world of science. There is tremendous potential for these technologies to solve a wide 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 the quality of drug products, and an increase in the demand for pharmaceuticals. Nanorobotics is a new subfield that has emerged from the field of robotics itself. This technique makes use of robots that 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, are extensively discussed throughout this article. Internationally renowned pharmaceutical companies are collaborating with Artificial Intelligence behemoths in order to revolutionise the discovery and development process of potential drug molecules and to ensure the highest possible quality in their products.


Author(s):  
Tanya Ralli ◽  
Vivekanandan Kalaiselvan ◽  
Ritu Tiwari ◽  
Shatrunajay Shukla ◽  
Kanchan Kholi

Introduction: Silymarin 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. Aims of this review: This 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. Methods: Information 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. Key findings: 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. Conclusion: Phytochemical 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.


Author(s):  
Sankha Bhattacharya ◽  
Dnyanesh Saindane

: Intellectual 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.


Author(s):  
Qaiser Jahan ◽  
K. Pallavi ◽  
R. Hamshika ◽  
Varun Talla ◽  
Jupally Venkateshwar Rao ◽  
...  

Background: 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. Objective: The objective of the present study was to identify and assess the drug-related problems in the pediatric department of tertiary care hospitals. Methods: The 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. Results: 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. Conclusion: The 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.


Author(s):  
Amit Dang ◽  
Dimple Dang ◽  
Pawan Rane

: The 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.


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