Introduction Of New Medicines Research Articles

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.

The European Medicines Agency's conditional marketing authorization (CMA) aims to expedite patient access to medicines for unmet medical needs by shifting a part of the drug development process post-authorization. We highlight ethical issues surrounding CMA, comprising (i) the complexity of defining unmet medical need; (ii) poor understanding of CMA and its impact on informed consent; (iii) hope versus unrealistic optimism; (iv) implications of prolonged post-authorization studies and potential patient harm; (v) rights and duties of patients surrounding participation in post-authorization studies; (vi) access to previously authorized CMA medicines; and (vii) the "benefit slippage" phenomenon, defined as the gradual shift of strict criteria to less strict criteria. We propose a comprehensive research agenda to address these ethical issues, and stress the need for multi-stakeholder engagement to ensure patient-centered use of CMA.

Использование метода многоволновой спектрофотометрии при контроле качества тизоля геля и метронидазола в новой мягкой лекарственной форме «Метронидазоль»

Introduction. For the introduction of new medicines into medical practice, a mandatory stage is quality control, which includes determining the quantitative content of active components using modern methods of pharmaceutical analysis. Tizol gel, included in soft dosage forms, is an independent pharmacologically active agent, therefore it is important to evaluate its content in complex medicinal preparations. Aim. To develop a method for quantitative determination of tizol gel and metronidazole in a new semisolid dosage form «Metronidazole» using multiple-wavelength spectrophotometry. Materials and methods. Pharmaceutical substance metronidazole, tizol gel, «Metronidazole» ointment containing 5% nitroimidazole in a tizol base was used for analysis. The studies were performed on spectrophotometer SF-2000 by multiple-wavelength spectrophotometry in the UV region. On the basis of experimental data, the metrological parameters of the developed analytical technique were calculated. Results and discussion. Experimental studies allowed us to justify the use of an acetate buffer solution with pH = 4 as the optimum solvent for the spectrophotometric analysis of tisol gel and metronidazole in the mixture. Analytical wavelengths (238 nm for tisol gel, 316 nm for metronidazole) were selected according to the UV spectra of the drugs obtained. According to the results of quantitative determination of the components of the Metronidazole ointment, the content of medicines is within the limits: metronidazole from 0.4900 to 0.5219 g, tizol gel (in terms of the mass fraction of titanium) – 2.32–2.46%, which are acceptable according to regulatory documentation (FSF 42-3157-06, OFS.1.8.0001). Conclusion. Quantitative analysis of tisol gel in complex pharmaceutical preparations was proposed for the first time. The method of quantitative determination by multiple-wavelength spectrophotometry has been developed which allows to determine the content of tizol gel and metronidazole in a new semisolid dosage form «Metronidazole» with relative errors of the average result not exceeding ± 3.00%.

Promotional Tools in Pharmaceutical Marketing

Medicine are a core part of health-care services and their use has grown enormously during the last century with the advent of effective Antibiotics, Anesthetics, Analgesics, Anti-retroviral and many other medicines, they can cure diseases, relieve symptoms and prevent future ill health. Appropriate medicine use means providing the right medicine at the right dose, when it is needed and avoiding medicine that are unnecessary or are unlikely to result in health benefits it means choosing the treatment with the best effectiveness and safety profile among available alternatives and the least costly of equivalent treatments. The international pharmaceutical industry plays an important role in the development, production and distribution of medicines. In many countries it has also become the major funder of continuing medical education (CME) and research. However, a tension exists between pressure to expand products sales within a competitive market and patient care. The World Health Organization (WHO) describe" an inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way"( WHO Europe 1993)1 The Global Medicine Market: In 2007, global pharmaceutical sales amounted to US $ 712 billion (IMS 2008)2 The top product in term of sales, was the cholesterol lowering medicine, Lipitor (Atorvastatin), which had sales of US $ 13.6 billion (scrip.2007)3. This is more than the gross national income of over half of the world’s countries (World Bank, 2008)4. The effects of promotion in fueling sales of specific brands should not be underestimated e.g. sales of Lipitor (Atorvastatin) were higher than sales of simvastatin and Provaststin, two medicine in the same class that have similar effectiveness and are less costly (Preserire, 2006) 5. Newer Medicine are not necessarily better: To get a new medicine to market, a company must provide evidence of effectiveness, safety and manufacturing quality. Effectiveness and safety evidence includes laboratory animal and clinical studies. The largest are phase III randomized controlled trials in patient with the disease the medicine aims to treat. Most of these studies compare a new medicine to a placebo. Many people are unaware that manufacturers do not need to show that a new medicine is better than existing compound with placebo and be acceptably safe. To test the medicine 's efficacy, the manufacturers carried out the randomized, controlled trials involving patients with the condition to be treated by the new medicine. These are usually relatively short-term studies and many last a few weeks to a few months, even when the treatment for a chronic disease. For some serious disease for which placebo treatment would be unethical, a new medicine is compared with existing treatments. However, these studies aim to show that a new medicine is as effective as alternatives, or no less effective, it does not need to be better, when a new medicine comes to the market.it has only been tested on highly selected groups of clinical trials participants. e.g. the elderly and those with co-morbid, chronic conditions are usually excluded. To few people have been exposed to asses’ rare harmful effects, generally 3, 000 to 5, 000 peoples. Because of this inevitably incomplete safety assessment, there is a rational from a public health perspective and an individual patient Care perspective for a slow, cautious approach to the introduction of new medicines.

The Establishment of the Concept of Shu Yi and Its Significance in the History of Knowledge

Plague is one of the severe infectious diseases which has had a huge impact on human society throughout history. Although there is abundant research on the disease, few studies focus on the concept of plague itself. It is generally believed that Shu Yi was first coined by Chinese doctors in the late 19th century, and it was closely related to the introduction of new medicine. This statement is not accurate, because plague was prevalent in Yunnan and Guangdong provinces in the late Qing Dynasty. At that time, people had already recognized the relationship between the outbreak of plague and the death of rats, and gradually named the epidemic disease as Shu Yi. This name was used by literati and doctors by coincidence. As the epidemic became more and more serious, more related works were widely disseminated, and Shu Yi changed from a folk name to a formal name. Later, with the help of the government’s active introduction of modern health and epidemic prevention mechanisms and the implementation of rodent control measures, Shu Yi became more popular and gradually recognized by all walks of society. The emergence and prevalence of Shu Yi created the history of zoonosis in China, and thus formed a new paradigm of naming human epidemics after related animal names.

PHARMACISTS’ VIEW OF DRUG PROMOTION BY SALES REPRESENTATIVES: A SURVEY FROM INDONESIA


 
 
 Interactions between pharmaceutical representatives and pharmacists are increasing. This study aimed to evaluate pharmacists’ views towards the drug promotion conducted by sales representatives in Indonesia. Adopting a cross-sectional survey study design, pharmacists completed questionnaires (n=120) to examine attitudes toward drug promotion by sales representatives, perception of the impact of drug promotion on attitudes and knowledge, and their experience in training in dealing with sales representatives and drug promotion. A total of 120 pharmacists participated in the study, of these; the majority of the respondents were females (80.83%) and aged 30-45 years (45.00%). Most respondents (55.83%) had experience in practice collaboration with doctors. However, only a small number of respondents (25.83%) were trained in drug promotion ethics. Approximately 71.67% of pharmacists do not agree with pharmaceutical company support of conferences and speakers, and the majority of respondents (73.33%) do not agree on the appropriateness of gifts provided by pharmaceutical companies. The majority of respondents believe that discussions with sales representatives impact prescribing (76.67%) and receiving gifts influences prescribing (72.50%). We found that majority of pharmacists accept promotion as a source of drug promotion and promotion as a source of information for the introduction of new medicines. Teaching the ethics or effects of drug company promotion has been never taught in pharmacy education. It is recommended that the structured curriculum of pharmacy education include courses/discussion groups on the ethical relationship between pharmacists and pharmaceutical companies.
 
 

PP89 The Investigation And Development Of A National Formulary Monitoring System Across Wales

IntroductionThe New Treatment Fund (NTF), launched in January 2017, aims to support the faster introduction of new medicines recommended by the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG). The NTF requires seven health boards and one trust to make recommended medicines available within 60 days of any positive recommendation decision. The project goal was to develop a system for demonstrating how monitoring the NTF improves medicines access for the people of Wales.MethodsThe process was derived via a series of task and finish group meetings with relevant stakeholders. The monitoring criteria were agreed through a collaborative expert approach using a nominal group technique. This determined a minimal dataset of formulary status, which included time to formulary addition. Pre-NTF medicines data (n = 59) were available for a six-month period.ResultsBy the three-year milestone of the NTF, the average time taken for newly recommended medicines (n = 219) to become available to patients across Wales had decreased by eighty-five percent from 90 to 13 days (p < 0.01).ConclusionsAn innovative and robust system has been created for accurately monitoring the formulary addition of medicines within the NTF, supporting the rapid and comprehensive uptake of medicines deemed clinically and cost effective by NICE and the AWMSG.

Alternative Splicing Role in New Therapies of Spinal Muscular Atrophy.

It has been estimated that 80% of the pre-mRNA undergoes alternative splicing, which exponentially increases the flow of biological information in cellular processes and can be an attractive therapeutic target. It is a crucial mechanism to increase genetic diversity. Disturbed alternative splicing is observed in many disorders, including neuromuscular diseases and carcinomas. Spinal Muscular Atrophy (SMA) is an autosomal recessive neurodegenerative disease. Homozygous deletion in 5q13 (the region coding for the motor neuron survival gene (SMN1)) is responsible for 95% of SMA cases. The nearly identical SMN2 gene does not compensate for SMN loss caused by SMN1 gene mutation due to different splicing of exon 7. A pathologically low level of survival motor neuron protein (SMN) causes degeneration of the anterior horn cells in the spinal cord with associated destruction of α-motor cells and manifested by muscle weakness and loss. Understanding the regulation of the SMN2 pre-mRNA splicing process has allowed for innovative treatment and the introduction of new medicines for SMA. After describing the concept of splicing modulation, this review will cover the progress achieved in this field, by highlighting the breakthrough accomplished recently for the treatment of SMA using the mechanism of alternative splicing.

Challenges in Positioning and Penetration of a New Medicine in the Minds of The Physicians: An Opinion Survey of Medical Representatives

This study examines the challenges faced by medical representatives in positioning and penetrating a new medicine in the minds of physicians. A survey of medical representatives was conducted to explore the key challenges, which include competition from established brands, limited time with physicians, lack of physician awareness, and limited access to physicians. These challenges can hinder the successful introduction of new medicines in the market. Therefore, it is essential for pharmaceutical companies to develop effective marketing strategies to overcome these obstacles. The findings of this study can inform the development of such strategies, which can lead to successful positioning and penetration of new medicines in the market

Value-based estimate of market size and opportunity for economic benefit through innovative pancreatic cancer (PC) therapies.

e16790 Background: Over the past 20 years, cancer drugs have contributed to increased life expectancy, reduced mortality, decreased hospitalization and decreased use of medical services. The economic value of these improvements is about as large as the value of the increase in the US gross domestic product during that time period. Recently, a health economic study presented at ASCO GI 2020 cited that every $1 (adjusted for inflation) spent on innovative PC treatments reduced non-drug expenditures by $9, thereby lowering the total cost of care for PC patients. Accordingly, the commercial opportunity of a new therapy should be measured by some combination of the clinical, economic and social value generated. We demonstrate the value of a novel PC drug from this perspective. Methods: Analysis of SEER survival and incidence data between 2008 and 2016 shows the introduction of new medicines for PC of all stages was associated with a cumulative increase of 26,456 life years, or 2.52 life years per patient. It was also associated with quality of life improvements, measured by a decline in hospitalizations rates and emergency room visits that can also lead to more days at work, at school and with family. Several studies have suggested the average value of an additional year of life, for the age of a typical patient diagnosed with PC, is at least $250,000. Using this figure, the value of 26,456 life years gained from 2008-2016 is $6.61 billion (26,456*$250,000) to patients, the healthcare system and society, as a result of advancing medical innovation for patients with PC. Results: The median annual list price of a life-enhancing cancer therapy is $150,000 per patient. Using the NCI treatment prevalence estimator (holding incidence constant), we estimate that between 2020-2025, there will be an additional 10,728 advanced PC patients requiring treatment who could benefit from innovative drugs. The total cost of these drugs for these patients would be $1.61 billion. However, the economic value of the life years saved would be $6.76 billion (10,728*2.52 life years*$250,000 = $6.76 billion). A review of cancer medicine payor coverage suggests a new PC therapy that produces such value would be able to obtain coverage from US payors given this value-based price. Conclusions: A value-based approach to estimating the opportunity for clinical and economic benefit reveals significant potential for new PC medicines.

Forecasting drug utilization and expenditure: ten years of experience in Stockholm

BackgroundOperating under constrained budgets, payers and providers globally face challenges in enabling appropriate and sustainable access to new medicines. Among payer initiatives aiming to improve preparedness of healthcare systems for the introduction of new medicines, drug utilization and expenditure forecasting has played an increasingly important role. This study aims to describe the forecasting model used in Region Stockholm and to evaluate the accuracy of the forecasts produced over the past decade.MethodsIn this repeated cross-sectional study, we compared the predicted pharmaceutical expenditure with actual expenditure during the entire available follow-up period (2007–2018) both for overall drug utilization and for individual therapeutic groups. All analyses were based on pharmaceutical expenditure data that include medicines used in hospitals and dispensed prescription medicines for all residents of the region.ResultsAccording to the forecasts, the total pharmaceutical expenditure was estimated to increase between 2 and 8% annually. Our analyses showed that the accuracy of these forecasts varied over the years with a mean absolute error of 1.9 percentage points. Forecasts for the same year were more accurate than forecasts for the next year. The accuracy of forecasts also differed across the therapeutic areas. Factors influencing the accuracy of forecasting included the timing of the introduction of both new medicines and generics, the rate of uptake of new medicines, and sudden changes in reimbursement policies.ConclusionsBased on the analyses of all forecasting reports produced since the model was established in Stockholm in the late 2000s, we demonstrated that it is feasible to forecast pharmaceutical expenditure with a reasonable accuracy. A number of factors influencing the accuracy of forecasting were also identified. If forecasting is used to provide data for decisions on budget allocation and agreements between payers and providers, we advise to update the forecast as close as possible prior to the decision date.

Coronavirus Disease (COVID-19): Spread, Awareness and Strategic Containment

Whenever, there is introduction of new medicine, medical intervention, new technology, studies, research, etc., world feels excited. The reason for this excitement is that everyone feels that lives will become better on this earth. On the contrary, the world of 21st century has been caught unaware from the dreadful Coronavirus disease (COVID-19), that is killing thousands of people every day irrespective of their economic or social status, and affiliation to developed, developing and under-developed countries. While writing this paper, the unfortunate death toll due to COVID-19 is highest in USA, known as strongest nation of the world due to its economic, military and technological development. This paper is an attempt of understanding the awareness level of people towards the precautions for containing coronavirus disease (COVID-19) in India through the engagement and integrated approach of Indian Government; based on the factors - social distancing, washing hands effectively and frequently, staying at home. On the basis of conducting survey and analyzing the data related to awareness (towards the precautions to combat this dreadful virus) of people in India, the results show that the government was able to make people aware in the shortest time. The awareness of public about the precautions and utility of lockdown proved useful resulting in much lessor causalities in India in comparison to the countries which delayed in taking these initiatives. Indian model of confining the virus seems to be valid till the appearance of COVID-19 treatment. How to cite this article:Sarin A, Sarin A. Coronavirus Disease (COVID-19): Spread, Awareness and Strategic Containment. J Commun Dis 2020; 52(1): 22-31. DOI: https://doi.org/10.24321/0019.5138.202004

Different ketogenesis strategies lead to disparate seizure outcomes

BackgroundDespite the introduction of new medicines to treat epilepsy over the last 50 years, the number of patients with poorly-controlled seizures remains unchanged. Metabolism-based therapies are an underutilized treatment option for this population. We hypothesized that two different means of systemic ketosis, the ketogenic diet and intermittent fasting, would differ in their acute seizure test profiles and mitochondrial respiration. MethodsMale NIH Swiss mice (aged 3–4 weeks) were fed for 12–13 days using one of four diet regimens: ketogenic diet (KD), control diet matched to KD for protein content and micronutrients (CD), or CD with intermittent fasting (24 h feed/24 h fast) (CD-IF), tested post-feed or post-fast. Mice were subject to the 6 Hz threshold test or, in separate cohorts, after injection of kainic acid in doses based on their weight (Cohort I) or a uniform dose regardless of weight (Cohort II). Mitochondrial respiration was tested in brain tissue isolated from similarly-fed seizure-naïve mice. ResultsKD mice were protected against 6 Hz-induced seizures but had more severe seizure scores in the kainic acid test (Cohorts I & II), the opposite of CD-IF mice. No differences were noted in mitochondrial respiration between diet regimens. InterpretationKD and CD-IF do not share identical antiseizure mechanisms. These differences were not explained by differences in mitochondrial respiration. Nevertheless, both KD and CD-IF regimens protected against different types of seizures, suggesting that mechanisms underlying CD-IF seizure protection should be explored further.

PREDICTION MARKETS AS A DECISION SUPPORT TOOL IN DISASSEMBLING COMPANIES

Dp arts. However, due to the large number of dismantled parts and limited storage area, corresponding to the law requirements, it is necessary to anticipate the demand for the most sold parts. The high importance level of spare parts flow is a consequence of high economic potential as well as ecologic. Used spare parts are main source of revenues for disassembling companies, they are wanted by customers, and what is the most relevant – the utilization of used spare parts is the best scenario for products, which achieved end – of – life stage (vehicle). Disassembling companies mostly represents small and medium sized companies, what is related with low level of computerization, at each area of business activity, including recording parts selling and demand forecasting. In order to support decisions made at this area, it was prepared a concept of a tool based on the research method of predictive markets to anticipate the demand for used parts in dismantling facility. Predictive markets are based on the idea of crowdsourcing, using collective crowd intelligence to predict for example introduction of new medicines on the market, the directions of development of new technologies or competition activities. In the paper it was presented original approach to the demand forecasting in specific business which core flow is a reverse flow of waste.

3.3 - A Model For Managed Introduction Of New Medicines In Sweden

3.3 - A Model For Managed Introduction Of New Medicines In Sweden

Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia.

Active surveillance pharmacovigilance systems better estimate the burden of adverse events (AEs) and can generate useful information on risk factors of AEs for more effective medicine use, especially in conjunction with introduction of new medicines and/or changes in treatment guidelines. This project aimed to implement an active surveillance pilot program for first-line antiretroviral therapy (ART) at sentinel sites in Namibia. Sentinel sites were outpatient ART clinics at the Windhoek Central Hospital and Katutura Intermediate Hospital. An active surveillance data collection form was developed and placed into patient charts. HIV+ adults naïve to ART were enrolled. Physicians recorded ART and health information during each follow-up visit, including presence or absence of AEs. A total of 413 patients were included from August 2012 to April 2013. Average age was 37 years; 51% of patients were at WHO clinical stage 1; and mean baseline CD4 count was 216. The most common ART regimen was tenofovir/lamivudine/nevirapine. Presence or absence of AEs was recorded in active surveillance forms for 94% of first follow-up visits. In total, 66 patients experienced 119 AEs of any severity. Incidence of experiencing at least one AE was 33/100 person-years. Most common AEs were rash and abdominal pain. On active surveillance forms, demographic variables were missing in 14% of patients, and follow-up visits were recorded for 82% of patients. Completeness of AE recording on active surveillance forms was high. With improved logistical considerations, such as incorporation of active surveillance forms into medical records, long-term active surveillance programs could be successful. Copyright © 2016 John Wiley & Sons, Ltd.

Medicines optimisation in Northern Ireland - scope and results of a challenging project

In Northern Ireland (NI), a Medicines Optimisation (MO) project has been successfully implemented by the Northern Health and Social Care Trust (NHSCT) over the last few years and continues to be developed. Historically, the approach taken to reduce medicine expenditure has been to focus almost exclusively on costs and cost-cutting initiatives. This methodology has had only limited success, as it fails to address the more fundamental aspects of the quality and safety of medicine use. Hence, in NI a new strategy was adopted, based on the premise that quality and safety drive health gain and economy. Thus, the model STEPSelect was developed (Safe Therapeutic Economic Pharmaceutical Selection) to ensure that medicine selection is fundamentally based on clinically related content such as efficiency, safety, documented effects on clinical end points and ease of administration. STEPSelect is a web-based tool developed by Digitalis Mm Ltd, enabling clinicians and other health care providers and managers to comprehensively select and procure medicines and medical devices. The rationale for STEPSelect is that successful introduction of new medicines does not merely depend on clinical features of medicines only. Other factors, which are decisive for early adoption of new medicines are the knowledge base clinicians have of new medicines relative to existing ones and ownership and fellow peer review, when deciding about prescribing new medicines. STEPSelect is based on System of Objectified Judgment Analysis (SOJA) technology. SOJA is a selection method to facilitate rational drug selection and create a new quality in prescribing based on objectified consensus among clinicians. The STEPSelect method looks in the first instance at clinical features of health technologies. At a later stage of the evaluation, product quality and fitness for purpose are assessed (the so-called risk assessment stage) as well as the budget impact of a health technology and appropriate procurement steps and routines. Evaluations are carried out by Expert Groups, which are composed on the basis of a multidisciplinary nature consisting of clinicians, pharmacists, nurses and other staff as appropriate. In NI the STEPSelect technology has been applied to procurement of medicines in many different therapeutic groups such as statins, erythropoietin stimulating agents (ESA's) and the use of biologicals in rheumatoid arthritis. Results with the method have invariably been positive in terms of support by clinicians and quality and cost reductions of prescribing, often in the region of 20-25% per therapeutic group.

Quality Indicators as a Tool in Improving the Introduction of New Medicines

Quality indicators are increasingly used as a tool to achieve safe and quality clinical care, cost-effective therapy, for professional learning, remuneration, accreditation and financial incentives. A substantial number focus on drug therapy but few address the introduction of new medicines even though this is a burning issue. The objective was to describe the issues and challenges in designing and implementing a transparent indicator framework and evaluation protocol for the introduction of new medicines and to provide guidance on how to apply quality indicators in the managed entry of new medicines. Quality indicators need to be developed early to assess whether new medicines are introduced appropriately. A number of key factors need to be addressed when developing, applying and evaluating indicators including dimensions of quality, suggested testing protocols, potential data sources, key implementation factors such as intended and unintended consequences, budget impact and cost-effectiveness, assuring the involvement of the medical professions, patients and the public, and reliable and easy-to-use computerized tools for data collection and management. Transparent approaches include the need for any quality indicators developed to handle conflict of interests to enhance their validity and acceptance. The suggested framework and indicator testing protocol may be useful in assessing the applicability of indicators for new medicines and may be adapted to healthcare settings worldwide. The suggestions build on existing literature to create a field testing methodology that can be used to produce country-specific quality indicators for new medicines as well as a cross international approach to facilitate access to new medicines.

Clinical experience in late antiquity: Alexander of Tralles and the therapy of epilepsy.

Alexander of Tralles, writing in the late sixth century, combined his wide-ranging practical knowledge with earlier medical theories. This article shows how clinical experience is used in Alexander’s works by concentrating on his therapeutic advice on epilepsy and, in particular, on pharmacology and the group of so-called natural remedies. I argue that clinical testing is used not only for the introduction of new medicines but also as an instrument for checking the therapeutic effect of popular healing practices. On another level, this article discusses Alexander’s role as the author of a medical compendium; it suggests that by marking the cases of clinical testing with a set of recurrent expressions, Alexander leads his audience to reflect on his medical authority and personal contribution.

The study of toxicological properties of “metroxal” cream

The presence of Demodex folliculorum mites exacerbates the number of dermatological conditions, such as rosacea and perioral dermatitis, and complicates their treatment. Development and introduction of medicines with the complex action in practical medicine exhibiting anti-parasitic properties against Demodex folliculorum and possessing the antibacterial, anti-inflammatory, capillary-restorative, anti-edemic, antioxidant and anti-allergic effect are of great current interest. One of the stages of introduction of new medicines is to study toxicity, which allows to assess their safety. Acute toxicity, the skin-irritant effect of the cream containing metronidazole, salicylic acid, troxerutin and essential oil of lemon balm, as well as its anti-alterative activity have been experimentally investigated on the model of non-allergic contact subchronic dermatitis caused by turpentine. The results obtained show no toxicity and skin-irritant effect of the cream with a single topical application to rats in the doses of 500 and 15000 mg/kg; it allows to refer it to Class VI of practically non-toxic substances (LD > 15000 mg/kg) in accordance with the generally accepted classification of K.K.Sidorov. As a result of the study of the anti-alternative activity on the model of non-allergic contact subchronic dermatitis caused by turpentine it has been found that the cream under research reveals the anti-inflammatory action.

Taking stock: A multistakeholder perspective on improving the delivery of care and the development of treatments for Alzheimer's disease

Health-care stakeholders increasingly recognize that the scientific and economic challenges associated with Alzheimer's disease (AD) are simply too great for individual stakeholder groups to address solely from within their own silos. In the necessary spirit of collaboration, we present in this perspective a set of multicountry multistakeholder recommendations to improve the organization of existing AD and dementia care and the development of new treatments. In brief, the five recommendations are (1) health-care systems must make choices regarding the patient populations to be diagnosed and treated, (2) health-care systems should use an evidence-based standard of care, (3) increased collaboration between public and private institutions is needed to enhance research, (4) reimbursement end points need to be agreed on and validated, and (5) innovative business models should be used to spur the introduction of new medicines.