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Tytuł:
Journey so far with COVID 19 – a comprehensive review
Autorzy:
Roy, Sayak
Powiązania:
https://bibliotekanauki.pl/articles/2040138.pdf
Data publikacji:
2020-12-30
Wydawca:
Uniwersytet Rzeszowski. Wydawnictwo Uniwersytetu Rzeszowskiego
Tematy:
clinical trials
respiratory infection
treatment strategies
Opis:
Introduction. The occurrence of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has emerged as a global pandemic with huge death tolls. Coronavirus disease 2019 (COVID-19) may progress from minimal infection to serious respiratory failure mandating treatment for a continuum of developed disease condition. Aim. The purpose of this review is to summarize the findings related to epidemiology, clinical manifestations, modes of transmission, diagnosis and the treatment modalities (both experimental and repurposed) for COVID-19. Material and methods. Literature were searched using various search engines like PubMed, SCOPUS, EMBASE, J-Gate, Google Scholar to look for review articles, randomized controlled trial results, prospective studies and, retrospective studies done on COVID-19 for the purpose of this comprehensive review. Analysis of the literature. The transmission seems to be occurring through droplet, fomite and aerosols (rarely). Currently there is no specific/targeted vaccine available. Priority is highly placed to identify possible treatment approaches to circumvention this disease. Conclusion. Till we find a vaccine, we have to strategize to optimally use the existing evidence of the indirect effects of these various available drugs for therapy and maintain a strict protocol for prevention and we must use triage system to admit only those critically ill or having severe disease.
Źródło:
European Journal of Clinical and Experimental Medicine; 2020, 4; 303-317
2544-2406
2544-1361
Pojawia się w:
European Journal of Clinical and Experimental Medicine
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Opinia na temat projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE
Opinion on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Autorzy:
Wróbel, Włodzimierz
Powiązania:
https://bibliotekanauki.pl/articles/16728914.pdf
Data publikacji:
2012
Wydawca:
Kancelaria Sejmu. Biuro Analiz Sejmowych
Tematy:
Constitution
clinical trials
European Union
minors
Opis:
The main subject of the analysis is the question of conformity with Poland’s Constitution of the possibility of carrying out clinical trials on minors. The author concludes that the provisions of Article 31 of the proposed regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, providing for the possibility of conducting clinical trials on minors, which are not aimed to be delivered for health benefit of those persons, are inconsistent with Article 39 of the Constitution of the Republic of Poland.
Źródło:
Zeszyty Prawnicze BAS; 2012, 4(36); 99-106
1896-9852
2082-064X
Pojawia się w:
Zeszyty Prawnicze BAS
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
An analysis of certification processes for Good Clinical Practice and project management competencies
Autorzy:
Zawada, Marek
Gągała, Dorota
Powiązania:
https://bibliotekanauki.pl/articles/2027260.pdf
Data publikacji:
2021
Wydawca:
Uniwersytet Ekonomiczny w Katowicach
Tematy:
Certification
Clinical trials
Good Clinical Practice
Project management
Opis:
Aim/purpose - The purpose of this paper is to clarify the certification process of the Good Clinical Practice (GCP) competencies based on a comparison with the project management (PM) certification process. This aim was accomplished by model development. Originality/value/contribution - The paper raises research topics at the crossroads of project management, clinical trials, and GCP, topics that have been underdeveloped so far. The results might be significant for all organizations involved in conducting clinical research projects. The findings contribute to the quality of clinical trials and provide public assurance that the rights, safety, and well-being of trial subjects are protected and the clinical trial data are credible. Design/methodology/approach - The study was divided into three main phases: 1st phase - the identification of key characteristics of PM and GCP certification processes, 2nd phase - the development of certification models for PM and GCP, 3rd phase - the conclusions from in-depth interviews. Findings - As a result of the research, key characteristics of PM and GCP certification processes were identified, certification models for PM and GCP were developed. In addition, based on conclusions from in-depth interviews, solutions for organizing the way of confirming knowledge of GCP guidelines were proposed. Research implications/limitations - The proposed rules may be too complex and may exceed the needs and expectations of the clinical trial environment. The models focus on stakeholder relations, without the rules of certification granting procedures, to enable broader contextualization of the issues discussed in the paper. The analysis might be fragmented as it regards the sole certification process. The research refers to Poland only, hence it will be valuable to identify whether foreign authorities have the same attitude to the GCP competency certification model. It is recommended to increase the number of respondents' interviews to obtain results of higher validity and reliability.
Źródło:
Journal of Economics and Management; 2021, 43; 179-205
1732-1948
Pojawia się w:
Journal of Economics and Management
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Contemporary Trends in the Development of the Pharmaceutical Industry in the World
Autorzy:
Dorocki, Sławomir
Powiązania:
https://bibliotekanauki.pl/articles/439225.pdf
Data publikacji:
2014
Wydawca:
Uniwersytet Pedagogiczny im. Komisji Edukacji Narodowej w Krakowie
Tematy:
BRIC;
clinical trials;
pharmaceutical industry;
relocation;
USA
Opis:
The pharmaceutical industry remains today a prominent high-technology sector of the economy,and consistently maintains its competitiveness on the world market at a very high level. Similarly to aircraft and spacecraft manufacturing and the electro-energy industry, pharmaceutical industry belongs to a group of innovative high-technology industries, which are based on scientific research results processed for industrial activities. The purpose of this study is to present and analyse global trends currently observed in the pharmaceutical industry in the world. In an era of increasing globalization, new prime movers of the development of the pharmaceutical industry are the countries from peripheralregions, mainly members of the BRICS group. For this reason, this article focuses on the emerging Asian and Latin American markets, next to the United States and countries of Western Europe. At the beginning of the twenty-first century, Brazil and China deemed the stimulation of the pharmaceutical industry one of the prime determinants of their future economic development. The following paper at first presents characteristics of the pharmaceutical industry products: innovative and generic medicines, medications available without prescription, biological agents, biosimilars and pharmaceutical substrates. Furthermore, the author specifies the properties and rates the dynamics of changes that are taking place in the global pharmaceutical market, while explaining the specifics of the relocation of the pharmaceutical industry. By comparing the number of publications in the field of pharmacy in selected countries of the world, the author confirmed the increasing importance of this industry on the global economy. In the last part of the article, the author presents the structure, number and distribution of clinical trials on a global scale. To illustrate the trends currently taking place in the development of the pharmaceutical industry, the author used raw statistical data in the field of pharmacology and literature on the subject.
Źródło:
Prace Komisji Geografii Przemysłu Polskiego Towarzystwa Geograficznego; 2014, 25; 108-131
2080-1653
Pojawia się w:
Prace Komisji Geografii Przemysłu Polskiego Towarzystwa Geograficznego
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND
Autorzy:
Syroka-Marczewska, Katarzyna
Powiązania:
https://bibliotekanauki.pl/articles/915876.pdf
Data publikacji:
2017
Wydawca:
Katolicki Uniwersytet Lubelski Jana Pawła II
Tematy:
clinical trials
medicinal products
pharmacovigilance
pharmaceutical law
Opis:
A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.
Źródło:
Review of European and Comparative Law; 2017, 28, 1; 67-84
2545-384X
Pojawia się w:
Review of European and Comparative Law
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi
Legal opinion on the conformity with Poland’s Constitution of the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use
Autorzy:
Banaszak, Bogusław
Powiązania:
https://bibliotekanauki.pl/articles/16728916.pdf
Data publikacji:
2012
Wydawca:
Kancelaria Sejmu. Biuro Analiz Sejmowych
Tematy:
Constitution
clinical trials
European Union
health care
Opis:
The purpose of the opinion is not to examine thoroughly the proposal for a regulation but only to assess the legal basis for its issue, and to provide an analysis of those provisions of the proposal that may raise doubts about their conformity with the Constitution of the Republic of Poland. The main conclusions of the opinion relate to the lack of grounds for delegation by the Republic of Poland to the bodies of the European Union of the competence to regulate the issue of clinical trials on medicinal products for human use under primary law of the EU. Such delegation would infringe Article 90(1) of the Constitution. The author claims that the time limits specified in the proposal for regulation for action of the State make it impossible for Polish public authorities to implement obligations resulting from the preamble to the Constitution and their duties relating to protection of individual’s rights referred to in its Article 30.
Źródło:
Zeszyty Prawnicze BAS; 2012, 4(36); 107-117
1896-9852
2082-064X
Pojawia się w:
Zeszyty Prawnicze BAS
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
The benefits and limitations of using blue-blocking filters – a review of results of clinical trials
Autorzy:
Partyka, Aleksandra
Dyrek, Martyna
Sikorski, Piotr
Sikorska, Ewa
Powiązania:
https://bibliotekanauki.pl/articles/40521372.pdf
Data publikacji:
2024-03-30
Wydawca:
Uniwersytet Rzeszowski. Wydawnictwo Uniwersytetu Rzeszowskiego
Tematy:
blue light
blue-blocking filters
clinical trials
Opis:
Introduction and aim. Blue light is part of the natural light spectrum and plays a role in regulating the circadian rhythm. However, with the increasing use of electronic devices and energy-efficient lighting emitting high levels of artificial blue light, concerns are raised regarding its potential effect on human health. Blue-blocking filters have been developed and are advertised as a solution to be used in spectacles or intraocular lenses. This review aims to provide an in-depth analysis of the use of blue-blocking filters based on the results of clinical trials. Material and methods. This review included relevant original papers reporting on clinical trial results from PubMed, Science Direct, and Google Scholar databases using specified keywords. Analysis of the literature. Trials conducted with patients reveal mixed results, with some showing no significant changes in vision and reading abilities, while others indicating potential limitations such as reduced contrast vision. However, blue-blocking filters have demonstrated potential benefits in improving sleep quality and mood, particularly in patients with sleep disturbances or psychiatric disorders. The efficacy of blue-blocking filters in mitigating symptoms of digital eye strain remains inconclusive. Conclusion. Overall, this paper provides a comprehensive assessment of the benefits and limitations associated with the use of blue-blocking filters, highlighting the need for further investigation in certain areas.
Źródło:
European Journal of Clinical and Experimental Medicine; 2024, 22, 1; 194-200
2544-2406
2544-1361
Pojawia się w:
European Journal of Clinical and Experimental Medicine
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Specyfika niekomercyjnych badań klinicznych z udziałem uczelni medycznych
The specificity of non-commercial clinical trials with the participation of medical universities
Autorzy:
Ronowicz, Joanna
Powiązania:
https://bibliotekanauki.pl/articles/762595.pdf
Data publikacji:
2019-12-11
Wydawca:
Polskie Towarzystwo Farmaceutyczne
Tematy:
niekomercyjne badania kliniczne
Agencja Badań Medycznych
badania akademickie
Medical research
non-commercial clinical trials
academic clinical trials
Opis:
Non-commercial clinical trials play an increasingly essential role for global health. Thanks to them a progress of knowledge in medical and health sciences is possible. Non-commercial clinical trials are conducted without the participation of pharmaceutical companies, mainly in order to evaluate the effectiveness and safety of drug products already used in the pharmaceutical market. These studies are usually initiated by researchers working at medical universities and they are conducted in clinical hospitals. The Pharmaceutical Law states that the data obtained in non-commercial clinical trials cannot be used for marketing purposes and for changes to existing marketing authorizations. Non-commercial studies are usually carried out with the use of already registered drug products, but used in different dosages, different patient groups (eg. pediatric) or in another application. Non-commercial research leads to the development of new treatments for rare diseases which are rarely in the interest of pharmaceutical companies. This approach allows to broaden the knowledge of medicines, find a new application or a more effective dose. In Poland, non-commercial clinical trials constitute ca. 2-5% of all registered research. In the Western European countries, this rate is much higher (20-25%). There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. There is a need to support non-commercial clinical trials addressed to relevant questions about public health and clinical decisions. In Poland, more funding for non-commercial research is still needed. In February 2019, the Medical Research Agency was established as the institution responsible for the development in the field of medical and health sciences. It can be a significant step to support non-commercial clinical trials and consequently it may open access to advanced modern pharmacotherapies for patients or reduction in the cost of treatment of selected diseases.
Niekomercyjne badania kliniczne odbywają się bez udziału firm z sektora farmaceutycznego. Badania te są często inicjowane przez badaczy, będących pracownikami uczelni i prowadzone są w oparciu o szpitale kliniczne. Celem badania niekomercyjnego nie jest uzyskanie zysku w zakresie wytwarzania lub obrotu produktami leczniczymi. Badania niekomercyjne najczęściej prowadzone są z wykorzystaniem już zarejestrowanych produktów leczniczych, ale użytych w innym schemacie dawkowania lub w innym wskazaniu terapeutycznym. Badania niekomercyjne prowadzą do opracowywania nowych metod leczenia m.in. chorób rzadkich, w przypadku których podejmowanie nowych badań klinicznych rzadko spotyka się z zainteresowaniem firm farmaceutycznych. W krajach Unii Europejskiej około 20-25% nowo rejestrowanych badań klinicznych stanowią badania niekomercyjne. Tymczasem w Polsce wśród rejestrowanych co roku badań klinicznych zaledwie około 2-5% stanowią badania niekomercyjne. Powołana w lutym 2019 roku Agencja Badań Medycznych ma zapewnić źródło finansowania niekomercyjnych badań klinicznych, co powinno przełożyć się na opracowanie nowych metod farmakoterapii.
Źródło:
Farmacja Polska; 2019, 75, 10; 584-588
0014-8261
2544-8552
Pojawia się w:
Farmacja Polska
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE
Legal opinion on the conformity with Poland’s Constitution of the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Autorzy:
Czarny, Piotr
Powiązania:
https://bibliotekanauki.pl/articles/16728922.pdf
Data publikacji:
2012
Wydawca:
Kancelaria Sejmu. Biuro Analiz Sejmowych
Tematy:
Constitution
clinical trials
European Union
medical experimentation
Opis:
The main point of the legal opinion is the question of conformity with Poland’s Constitution of the proposal for regulation of the European Parliament and of the Council [COM (2012) 369 final]. In provides an in-depth analysis of matter presented (only in general terms) in the opinion dated 27 August 2012. The author claims that Article 30(1) of the proposed regulation should be declared to be partly (i.e. in relation to the scope of regulation) inconsistent with Article 39 of the Constitution. He points out that the Constitution establishes a prohibition against medical experimentation on the human subject (and this notion includes clinical trials referred to in the proposed regulation) without his personal and prior consent. No limitation of this right is allowed, except for when it collides with other “equivalent” constitutional values, especially the right to life protection (Article 38 of the Constitution) and the right to health protection (Article 68 of the Constitution).
Źródło:
Zeszyty Prawnicze BAS; 2012, 4(36); 149-158
1896-9852
2082-064X
Pojawia się w:
Zeszyty Prawnicze BAS
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Influenza prevention and treatment by passive immunization
Autorzy:
Kalenik, Barbara
Sawicka, Róża
Góra-Sochacka, Anna
Sirko, Agnieszka
Powiązania:
https://bibliotekanauki.pl/articles/1039265.pdf
Data publikacji:
2014
Wydawca:
Polskie Towarzystwo Biochemiczne
Tematy:
antibody
clinical trials
hemagglutinin
influenza
neutralization
passive immunity
Opis:
Passive immunity is defined as a particular antigen resistance provided by external antibodies. It can be either naturally or artificially acquired. Natural passive immunization occurs during pregnancy and breast-feeding in mammals and during hatching in birds. Maternal antibodies are passed through the placenta and milk in mammals and through the egg yolk in birds. Artificial passive immunity is acquired by injection of either serum from immunized (or infected) individuals or antibody preparations. Many independent research groups worked on selection, verification and detailed characterization of polyclonal and monoclonal antibodies against the influenza virus. Numerous antibody preparations were tested in a variety of in vitro and in vivo experiments for their efficacy to neutralize the virus. Here, we describe types of antibodies tested in such experiments and their viral targets, review approaches resulting in identification of broadly neutralizing antibodies and discuss methods used to demonstrate their protective effects. Finally, we shortly discuss the phenomenon of maternal antibody transfer as a way of effective care for young individuals and as an interfering factor in early vaccination.
Źródło:
Acta Biochimica Polonica; 2014, 61, 3; 573-587
0001-527X
Pojawia się w:
Acta Biochimica Polonica
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Karta praw osób starszych dotycząca ich udziału w badaniach klinicznych
The charter of older people rights to participate in clinical trials
Autorzy:
Szczerbińska, Katarzyna
Zalewski, Zbigniew
Oristrell Salvà, Joaquim
Powiązania:
https://bibliotekanauki.pl/articles/635155.pdf
Data publikacji:
2011
Wydawca:
Uniwersytet Jagielloński. Wydawnictwo Uniwersytetu Jagiellońskiego
Tematy:
clinical trials
elderly
discrimination
patients
rights
charter
PREDICT
Opis:
The results of initial literature review indicate that elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7. The goal of the PREDICT was to study reasons why older people are excluded from clinical trials based on age-related criteria and development of the charter including recommendations to prevent their exclusion. The project gathered investigators from 11 institutions in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. Within the scope of PREDICT, first, to assess the scope of the problem the systematic review of literature was performed, then the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of old people in trials was examined, then finally the opinion of elderly patients and their caregivers were assessed. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials
Źródło:
Zdrowie Publiczne i Zarządzanie; 2011, 9, 1; 119-127
2084-2627
Pojawia się w:
Zdrowie Publiczne i Zarządzanie
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Post-development sentiment and statistical analysis of different groups of psychiatric medications
Autorzy:
Ghassemi Toosi, Farshad
Ghassemi Toussi, Alireza
Powiązania:
https://bibliotekanauki.pl/articles/33894821.pdf
Data publikacji:
2024-06-25
Wydawca:
Gdański Uniwersytet Medyczny
Tematy:
anxiety
clinical trials
SSRIs
sentiment analysis
psychiatric medication
Opis:
Background Post-development analysis of medications allows for comprehensive understanding of the safety profile over extended periods, and can direct future improvements to enhance the therapeutic benefits while minimizing risks. Our primary goal was to examine whether a substantial relationship exists between such patient experiences and the statistical analysis of data about the same medications from clinical trials. Material and methods Patient feedback regarding medication commonly prescribed for psychiatric conditions was obtained from a publicly available website webmd.com. We searched clinicaltrials.gov for statistical analysis regarding the same medications. Data from webmd.com was subjected to sentiment analysis, while ClinicalTrials data underwent statistical analysis. Results The findings suggest a general connection between the two data sources. Medications with a greater amount of patient feedback generally attract more research attention, although with some exceptions. Additionally, medications approved for children receive less feedback online compared to those for adults and seniors. Medications for seniors receive more positive and neutral feedback in contrast to those for children and adults. Conclusions Online platforms offer a space for patients to share their experiences with using specific medications, potentially contributing to the enhancement of patient care and aiding researchers in further studies.
Źródło:
European Journal of Translational and Clinical Medicine; 2024, 7, 1; 47-56
2657-3148
2657-3156
Pojawia się w:
European Journal of Translational and Clinical Medicine
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
From business to clinical trials: a systematic review of the literature on fraud detection methods to be used in central statistical monitoring
Autorzy:
Fronc, Maciej
Jakubczyk, Michał
Powiązania:
https://bibliotekanauki.pl/articles/2176605.pdf
Data publikacji:
2023-02-28
Wydawca:
Główny Urząd Statystyczny
Tematy:
fraud detection
clinical trials
finance
data mining
big data
Opis:
Data-driven decisions can be suboptimal when the data are distorted by fraudulent behaviour. Fraud is a common occurrence in finance or other related industries, where large datasets are handled and motivation for financial gain may be high. In order to detect and the prevent fraud, quantitative methods are used. Fraud, however, is also committed in other circumstances, e.g. during clinical trials. The article aims to verify which analytical fraud-detection methods used in finance may be adopted in the field of clinical trials. We systematically reviewed papers published over the last five years in two databases (Scopus and the Web of Science) in the field of economics, finance, management and business in general. We considered a broad scope of data mining techniques including artificial intelligence algorithms. As a result, 37 quantitative methods were identified with the potential of being fit for application in clinical trials. The methods were grouped into three categories: pre-processing techniques, supervised learning and unsupervised learning. Our findings may enhance the future use of fraud-detection methods in clinical trials.
Źródło:
Przegląd Statystyczny; 2022, 69, 3; 1-22
0033-2372
Pojawia się w:
Przegląd Statystyczny
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Health Benefits of Vegetarian and Mediterranean Diets: Narrative Review
Autorzy:
Pieczyńska, Katarzyna
Rzymski, Piotr
Powiązania:
https://bibliotekanauki.pl/articles/2152152.pdf
Data publikacji:
2022-11-16
Wydawca:
Instytut Rozrodu Zwierząt i Badań Żywności Polskiej Akademii Nauk w Olsztynie
Tematy:
human diet
plant-based diets
clinical trials
meta-analysis
human health
Opis:
Diet is an important lifestyle factor influencing disease risk. Vegetarian and Mediterranean diets have their proponents and are promoted for various potential health benefits. Over the years, numerous cross-sectional and cohort studies and randomized clinical trials have been conducted to elucidate the relationship between the Mediterranean and vegetarian diet and cardiovascular, cancer, diabetes, and other disease risks. More recently, research has been conducted to compare both diets directly. In this narrative review, we discuss the effects of vegetarian and Mediterranean diets on lipid profile, blood pressure, inflammation markers, body weight, risk of cardiovascular disease, cancer, diabetes mellitus, metabolic syndrome, and chronic kidney disease, as well as their associations with gut microbiota and mental health. The paper also discusses the studies comparing vegetarian and Mediterranean diets and their health effects. It provides further evidence that both diets can be beneficial and advocates their promotion, especially in Westernized populations plagued by various chronic lifestyle-associated diseases. At the same time, the Mediterranean dietary model may appear to be a superior public health strategy, less prone to the risk of nutritional deficiencies and less challenging in implantation on a broader scale. However, further studies based on cross-over design and long-term observations are recommended to thoroughly compare vegetarian and Mediterranean diets and draw more firm conclusions on their effects on health.
Źródło:
Polish Journal of Food and Nutrition Sciences; 2022, 72, 4; 327-346
1230-0322
2083-6007
Pojawia się w:
Polish Journal of Food and Nutrition Sciences
Dostawca treści:
Biblioteka Nauki
Artykuł
Tytuł:
Wpływ przepisów prawa Unii Europejskiej o badaniach klinicznych produktów leczniczych na polskie prawo karne
The Influence of the EU Clinical Trials of Medicinal Products Legislation on the Polish Criminal Law
Autorzy:
Gałązka, Małgorzata
Powiązania:
https://bibliotekanauki.pl/articles/518916.pdf
Data publikacji:
2020
Wydawca:
Uniwersytet Jagielloński. Fundacja Utriusque Iuris
Tematy:
UE law
criminal law
medical law
pharmaceutical law
criminalisation
clinical trials
Opis:
The article raises the question of the influence of the EU clinical trials of medicinal products legislation on the Polish criminal law. Although this issue does not fall within the scope of the Article 83 of the Treaty on Functioning of the European Union, its significant importance results from the expected beginning of application of the Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. The impact of the EU legislation on member states’ criminal law in the field of clinical trials is based on the principle of pri- macy. Three directions of this impact can be distinguished concerning Regulation No. 536/2014. The first is the exclusion of the unlawfulness of the acts prohibited by the chapter 19 of the Polish Criminal Code within the scope of the prerequisites for the admissibility of clinical trials. The second is the de facto depenalisation of the behaviors described by in Article 126a (1) (3–5) of Pharmaceutical Act. The indicated two effects may take place ex lege with the beginning of application of Regulation No. 536/2014, if there is no change in the Polish law beforehand. The realisation of the third direction depends on the decision of the Polish legislator, who is required to introduce effective, proportionate and dissuasive penalties applicable to infringements of the Regulation No. 536/2014. The type of these measures is left to the discretion of the member states, but the current legal situation combined with the principle of assimilation prompts us to suppose that the choice of criminal penalties will be sustained.
Źródło:
Forum Prawnicze; 2020, 2 (58); 56-75
2081-688X
Pojawia się w:
Forum Prawnicze
Dostawca treści:
Biblioteka Nauki
Artykuł
Wyświetlanie 1-15 z 27

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