pharmaceutical research
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Author(s):  
Maharshi Thalla ◽  
Purushottam Suryavanshi ◽  
V. G. M. Naidu ◽  
Upadhyayula Suryanarayana Murty ◽  
Subham Banerjee

Materials ◽  
2022 ◽  
Vol 15 (2) ◽  
pp. 419
Author(s):  
Mikołaj Dembek ◽  
Szymon Bocian

Industrial research, including pharmaceutical research, is increasingly using liquid chromatography techniques. This involves the production of large quantities of hazardous and toxic organic waste. Therefore, it is essential at this point to focus interest on solutions proposed by so-called “green chemistry”. One such solution is the search for new methods or the use of new materials that will reduce waste. One of the most promising ideas is to perform chromatographic separation using pure water, without organic solvents, as a mobile phase. Such an approach requires novel stationary phases or specific chromatographic conditions, such as an elevated separation temperature. The following review paper aims to gather information on stationary phases used for separation under purely aqueous conditions at various temperatures.


2021 ◽  
Vol 12 ◽  
Author(s):  
Zhonghong Yan ◽  
Guanran Wang ◽  
Xingyang Shi

Chronic kidney disease (CKD) is one of the increasingly serious public health concerns worldwide; the global burden of CKD is increasingly due to high morbidity and mortality. At present, there are three key problems in the clinical treatment and management of CKD. First, the current diagnostic indicators, such as proteinuria and serum creatinine, are greatly interfered by the physiological conditions of patients, and the changes in the indicator level are not synchronized with renal damage. Second, the established diagnosis of suspected CKD still depends on biopsy, which is not suitable for contraindication patients, is also traumatic, and is not sensitive to early progression. Finally, the prognosis of CKD is affected by many factors; hence, it is ineviatble to develop effective biomarkers to predict CKD prognosis and improve the prognosis through early intervention. Accurate progression monitoring and prognosis improvement of CKD are extremely significant for improving the clinical treatment and management of CKD and reducing the social burden. Therefore, biomarkers reported in recent years, which could play important roles in accurate progression monitoring and prognosis improvement of CKD, were concluded and highlighted in this review article that aims to provide a reference for both the construction of CKD precision therapy system and the pharmaceutical research and development.


2021 ◽  
Author(s):  
Julia Katharina Metz ◽  
Marius Hittinger ◽  
Claus-Michael Lehr

AbstractThe drug development process is a lengthy and expensive challenge for all involved players. Experience with the COVID-19 pandemic underlines the need for a rapid and effective approval for treatment options. As essential prerequisites for successful drug approval, a combination of high-quality studies and reliable research must be included. To this day, mainly in vivo data are requested and collected for assessing safety and efficacy and are therefore decisive for the pre-clinical evaluation of the respective drug. This review aims to summarize the current state of the art for safety and efficacy studies in pharmaceutical research and industry to address the relevant regulatory challenges and to provide an outlook on implementing more in vitro methods as alternative to animal testing. While the public demand for alternative methods is becoming louder, first examples have meanwhile found acceptance in relevant guidelines, e.g. the OECD guidelines for skin sensitizer. Besides ethically driven developments, also the rather low throughput and relatively high costs of animal experiments are forcing the industry towards the implementation of alternative methods. In this context, the development of orally inhaled drug products is particularly challenging due to the complexity of the lung as biological barrier and route of administration. The replacement of animal experiments with focus on the lungs requires special designed tools to achieve predictive data. New in vitro test systems of increasing complexity are presented in this review. Limits and advantages are discussed to provide some perspective for a future in vitro testing strategy for orally inhaled drug products. Graphical abstract


2021 ◽  
pp. 1-12
Author(s):  
Laurent Servais ◽  
Karl Yen ◽  
Maitea Guridi ◽  
Jacek Lukawy ◽  
David Vissière ◽  
...  

In 2019, stride velocity 95th centile (SV95C) became the first wearable-derived digital clinical outcome assessment (COA) qualified by the European Medicines Agency (EMA) for use as a secondary endpoint in trials for Duchenne muscular dystrophy. SV95C was approved via the EMA’s qualification pathway for novel methodologies for medicine development, which is a voluntary procedure for assessing the regulatory acceptability of innovative methods used in pharmaceutical research and development. SV95C is an objective, real-world digital ambulation measure of peak performance, representing the speed of the fastest strides taken by the wearer over a recording period of 180 hours. SV95C is correlated with traditional clinic-based assessments of motor function and has greater sensitivity to clinical change over 6 months than other wearable-derived stride variables, for example, median stride length or velocity. SV95C overcomes many limitations of episodic, clinic-based motor function testing, allowing the assessment of ambulation ability between clinic visits and under free-living conditions. Here we highlight considerations and challenges in developing SV95C using evidence generated by a high-performance wearable sensor. We also provide a commentary of the device’s technical capabilities, which were a determining factor in the regulatory approval of SV95C. This article aims to provide insights into the methods employed, and the challenges faced, during the regulatory approval process for researchers developing new digital tools for patients with diseases that affect motor function.


2021 ◽  
Vol 10 (4) ◽  
pp. 127-132
Author(s):  
V.V. Shapovalov (Jr.) ◽  
V.A. Shapovalova ◽  
V.V. Shapovalov

Background. Around the world, drug-related road traffic accidents are one of the leading causes of injury and death among road users. Traffic safety is a system that includes the following components: a person – a person's health condition – the use of dangerous drugs of different classification and legal groups – adverse drug reactions – a vehicle – a road. The share of road traffic accidents under the influence of drugs is more than 75 %, they are also the most socially dangerous, because they have grave consequences, cause irreparable harm to the health and death of the victims. The purpose of the study was to analyze the achievements of forensic and pharmaceutical researches in Ukraine on the impact of drugs on the safety, life and health of road users within the framework of the organization of pharmaceutical business, drug technology, pharmaceutical and medical law in a retrospective aspect. Materials and methods. The materials of the imperative research were legislative, regulatory and legal documents; materials of the formation of the scientific school of forensic pharmacy; scientific publications on the topic of the article; Internet resources, sources of scientific literature. To achieve the set goals, the methods of forensic and pharmaceutical, regulatory, documentary, bibliographic, comparative, historical and graphic analysis were used. Results. The experience of the countries of the world in the prophylaxis and prevention of road traffic accidents under the influence of drugs was analyzed. The causes and conditions for the occurrence and consequences of road traffic accidents are multifactorial in nature and are associated with the victims (driver - pedestrian), vehicle, road conditions, and the use of psychoactive drugs. A system of organizational, regulatory and preventive measures has been developed to provide first medical aid to victims of a road traffic accident. Shown that there is a need for scientifically grounded organizational and legal, clinical and pharmacological, forensic pharmaceutical and socio-economic studies on causal relationships between adverse reactions due to the use of drugs of various classification and legal groups, traffic safety and road traffic accidents. For the first time in Ukraine, a mathematical model was proposed to establish the effect of psychoactive drugs on the driver's condition when driving a vehicle, depending on the calculation of the stopping path of the car in accordance with the selected speed and a decrease in the driver's response. The structure of road traffic accidents under the influence of psychoactive drugs has been investigated. Conclusions. A classification of first-aid kits for providing first medical aid to victims of road traffic accidents was proposed, which made it possible to substantiate the need to improve them both in qualitative and quantitative composition, depending on the type of vehicle and the likelihood of an accident with serious consequences. Recommendations were proposed for providing information on the possibility of obtaining medical care and the signal-calling system on the roads, marking the packages of psychoactive drugs with a special mark in the form of a red triangle. The need for further forensic pharmaceutical research has been proven.


2021 ◽  
Vol 10 (3) ◽  
pp. 98-106
Author(s):  
V.V. Shapovalov (Jr.) ◽  
V.A. Shapovalova ◽  
V.V. Shapovalov

Background. In recent years, the COVID-19 pandemic has spread and is developing in all countries of the world without exception, affecting not only medical and pharmaceutical, but also social, economic, toxicological and criminal aspects. In such conditions, it is of great importance in the field of healthcare and the pharmaceutical industry of Ukraine to improve the system of legal relations "doctor-patient-pharmacist", based solely on the principles of pharmaceutical and medical law. Among the components of medical and pharmaceutical law there is forensic pharmacy, which studies the causes of offenses in the field of healthcare. The purpose of the study was to analyze history of formation and development of forensic and pharmaceutical researches in Ukraine within the organization of pharmaceutical business, drug technology and pharmaceutical law. Materials and methods. Legislative and regulatory documents were used in the study; scientific publications in the field of "forensic pharmacy"; Internet resources. Normative and legal, documentary, historical, bibliographic, forensic and pharmaceutical, comparative and graphic methods of analysis were used. Results. Forensic pharmacy in the world as a scientific field is known and developed since 1946. The article covers the period of 1990-2004. Prominent scientists of Ukraine were of great importance in the formation of forensic pharmacy. The formation of forensic pharmacy began with the generalization of forensic and pharmaceutical practice in historical retrospect "from police chemistry to forensic chemical and pharmaceutical examination – from forensic pharmacy to pharmaceutical law and medical law" with the support of prof. Chernykh V.P. In the period of 1997-2003, the development of forensic pharmacy took place by improving the regulatory and legal support of the control and licensing system of circulation of medicines. Trends in the prevalence of diseases involving uncontrolled and irrational use and abuse of surfactants have been identified. The causal links between drug addiction, substance abuse and crime have been investigated. The interpretation of "potent", "poisonous" substances in the regulations of Ukraine have been improved. It is substantiated that the main indicator of classifying drugs as "potent" and "poisonous" substance is a forensic criterion that qualifies the consequences of irrational use of drugs by severity of injuries: from mild, moderate to severe injuries, or those that caused fatalities. At the next stage (2003-2004) the scientific and theoretical generalization and the new approach to the decision of a problem which is connected with development of scientifically-based principles of optimization of system of the state control over circulation of narcotic drugs, psychotropic substances and precursors were studied. The possibility of participation of a pharmacy specialist (pharmacist-forensic scientist) at the stages of: investigation, pre-trial investigation in forensic chemical and pharmaceutical studies of physical evidence and participation as a forensic expert in a criminal case in court has been researched. Conclusions. It is substantiated that the formation of forensic and pharmaceutical researches within the organization of pharmaceutical business, drug technology and pharmaceutical law in Ukraine has taken place. Further forensic pharmaceutical research needed to harmonize domestic legislation, international human rights standards in the field of health care, legal regulation of the pharmaceutical market and the medical services market.


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