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  1. AU="Zornitsa Mitkova"
  2. AU="Nicholas Tadros"
  3. AU="Ntelkis, Nikolaos"
  4. AU=Pitrou Isabelle
  5. AU="Ouwehand, Willem"
  6. AU=Glover Natasha M.
  7. AU=Guo Zhinian
  8. AU="Alison M. Lee"
  9. AU="Walcher, Felix"
  10. AU=Marupudi Neena I.
  11. AU="Earp, Karly M"
  12. AU="Zeng, Hui Hui"
  13. AU="Marco Pallecchi"
  14. AU=Marcus Adam I
  15. AU="Martin, Phillip"
  16. AU=Ouyang Yi-Bing
  17. AU="Tam, Patrick Chung Kay"
  18. AU="Patrick R. H. Steinmetz"
  19. AU="Odierna, Francesco"
  20. AU="Monteiro, Valter" AU="Monteiro, Valter"
  21. AU=Konkel Alex
  22. AU="Alnakib, Yasir"
  23. AU=Tallerico Rossana
  24. AU=Scherer Kai
  25. AU="Cao, Guiyun"
  26. AU="Zarrouki, Youssef"
  27. AU="Abayomi, Akin"
  28. AU=Kpatcha Tchazou
  29. AU=Glaeser Robert M
  30. AU="Mioara Cristea"
  31. AU="Turiegano, Enrique"
  32. AU="Russcher, H"
  33. AU="Lim, Kean-Jin"
  34. AU="Spurek, Monika"
  35. AU="Giulia A. Zamboni"

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  1. Artikel ; Online: Analysis of the Household and Health Care System Expenditures in Bulgaria

    Zornitsa Mitkova / Guenka Petrova

    Frontiers in Public Health, Vol

    2021  Band 9

    Abstract: Health care systems worldwide are experiencing tremendous financial pressure because of the introduction of new targeted health technologies and medicines. This study aims to analyze and compare public and household healthcare expenditures in Bulgaria ... ...

    Abstract Health care systems worldwide are experiencing tremendous financial pressure because of the introduction of new targeted health technologies and medicines. This study aims to analyze and compare public and household healthcare expenditures in Bulgaria during the period 2015–2019, as well as present the major cost-containment measures implied by the government and their probable influence on the overall health care cost. Regulatory analysis of the endorsed cost-containment measures, budget analysis of public and household health care expenditures, and their extrapolations were performed. The regulatory analysis reveals that a large number of measures are introduced and valid until January 2021, considering pharmaceuticals, medical devices, and negotiations between the National Health Insurance Fund (NHIF) and Marketing authorization holders (MAHs). NHIF costs due to pharmaceuticals, food supplements, and medical devices are rising from 2015 to 2019. The overall health expenditures average per household and the average per person also grow in this period. The cost extrapolation reveals that an increase in 3-year periods is expected. Despite the implementation of variety of cost-containment measures in Bulgaria, such as HTA, ERP, discounts, and annual negotiations, The National Health Insurance Fund's (NHIF) spending on pharmaceuticals continues to rise in recent years, and further increases are expected in the next 3 years. The average expenditure per household and per person also increased, which confirms the global trend of rising medicine and outpatient services value.
    Schlagwörter public expenditures ; household expenditures ; healthcare expenditure ; cost containment measures ; Bulgaria ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 336
    Sprache Englisch
    Erscheinungsdatum 2021-07-01T00:00:00Z
    Verlag Frontiers Media S.A.
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  2. Artikel ; Online: Biosimilar Insulins and Their Impact on Prices and Utilization of Insulins in Bulgaria

    Konstantin Tachkov / Zornitsa Mitkova / Petya Milushewa / Guenka Petrova

    Healthcare, Vol 9, Iss 697, p

    2021  Band 697

    Abstract: The aim was to explore the availability of biosimilar insulins on the national market in Bulgaria and their impact on prices and utilization. This was a retrospective, quantitative, longitudinal study during the period 2014–2020. Authorized-for-sale, ... ...

    Abstract The aim was to explore the availability of biosimilar insulins on the national market in Bulgaria and their impact on prices and utilization. This was a retrospective, quantitative, longitudinal study during the period 2014–2020. Authorized-for-sale, biosimilar insulins at the European level were compared with those on the national market. Prices and utilization were compared in value, number of defined daily dose (DDD), and DDD/1000 inh/day. Almost all types of insulins possessed biosimilars, and even more than one on the European market, but only two were found to be available and reimbursed on the national market. The total number of reimbursed INNs was 11, and for seven of them, changes in reference price per DDD were found. The highest price decrease was observed for insulin (price per DDD decline from 2.77 to 2.22 Bulgarian Leva (BGN)). The total expenditure for insulin increased from 68 to approximately 72.8 mil BGN (34 to approximately 37 mil Euro). The utilization in DDD/1000/inh/day decreased from 16.12 to 15.31. Only two biosimilar insulins were found to be available on the national market, with a slow decrease in prices and stable utilization. Other regulatory and financial measures are probably necessary to foster the insulins’ competition at the biosimilar level.
    Schlagwörter biological ; biosimilar ; insulin ; competition ; prices ; utilization ; Medicine ; R
    Thema/Rubrik (Code) 332
    Sprache Englisch
    Erscheinungsdatum 2021-06-01T00:00:00Z
    Verlag MDPI AG
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  3. Artikel ; Online: Did the Introduction of Biosimilars Influence Their Prices and Utilization? The Case of Biologic Disease Modifying Antirheumatic Drugs (bDMARD) in Bulgaria

    Konstantin Tachkov / Zornitsa Mitkova / Vladimira Boyadzieva / Guenka Petrova

    Pharmaceuticals, Vol 14, Iss 1, p

    2021  Band 64

    Abstract: The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD). It is a combined qualitative and quantitative analysis of time of ... ...

    Abstract The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD). It is a combined qualitative and quantitative analysis of time of entry of biosimilars on the national market and the respective changes in the prices and utilization during 2015–2020. We found 58 biosimilars for 16 reference products authorized for sale on the European market by the end of 2019, but for 2 of the reference products biosimilars were not found on the national market. Only inflammatory joint disease had more than one biosimilar molecule indicated for therapy. Prices of the observed bDMARD decreased by 17% down to 48%. We noted significant price decreases upon biosimilar entrance onto the market. In total, the reimbursed expenditures for the whole therapeutic group steadily increased from 72 to 99 million BGN. Utilization changed from to 0.5868 to 2.7215 defined daily dose (DDD)/1000inh/day. Our study shows that the entrance of biosimilars in the country is relatively slow because only half of the biosimilars authorized in Europe are reimbursed nationally. Introduction of biosimilars decreases the prices and changes the utilization significantly but other factors might also contribute to this.
    Schlagwörter biosimilars ; pricing ; reimbursement ; utilization ; Medicine ; R ; Pharmacy and materia medica ; RS1-441
    Thema/Rubrik (Code) 330
    Sprache Englisch
    Erscheinungsdatum 2021-01-01T00:00:00Z
    Verlag MDPI AG
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  4. Artikel ; Online: Analysis of Healthcare Expenditures in Bulgaria

    Zornitsa Mitkova / Miglena Doneva / Nikolay Gerasimov / Konstantin Tachkov / Maria Dimitrova / Maria Kamusheva / Guenka Petrova

    Healthcare, Vol 10, Iss 274, p

    2022  Band 274

    Abstract: The growth of public expenditure worldwide has set the priority on assessment of trends and establishment of factors which generate the most significant public costs. The goal of the current study is to review the tendencies in public healthcare ... ...

    Abstract The growth of public expenditure worldwide has set the priority on assessment of trends and establishment of factors which generate the most significant public costs. The goal of the current study is to review the tendencies in public healthcare expenditures in Bulgaria and to analyze the influence of the demographic, economic, and healthcare system capacity indicators on expenditures dynamics. A retrospective, top-down, financial analysis of the healthcare system expenditures was performed. Datasets of the National Statistical Institute (NSI), National Health Insurance Fund (NHIF), and National Center of Public Health and Analysis (NCPHA) were retrospectively reviewed from2014–2019 to collect the information in absolute units of healthcare expenditures, healthcare system performance, demographics, and economic indicators. The research showed that increasing GDP led to higher healthcare costs, and it was the main factor affecting the cost growth in Bulgaria. The number of hospitalized patients and citizens in retirement age remained constant, confirming that their impact on healthcare costs was negligible. In conclusion, the population aging, average life expectancy, patient morbidity, and hospitalization rate altogether impacted healthcare costs mainly due to the multimorbidity of older people and the rising need for outpatient hospital services and medications.
    Schlagwörter public expenditure ; healthcare system performance ; demographics ; economic indicators ; Medicine ; R
    Thema/Rubrik (Code) 306
    Sprache Englisch
    Erscheinungsdatum 2022-01-01T00:00:00Z
    Verlag MDPI AG
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  5. Artikel ; Online: Treatment patterns, adherence to international guidelines, and financial mechanisms of the market access of advanced breast cancer therapy in Bulgaria

    Stephanie Karanyotova / Branimira Topova / Elina Petrova / Peter Doychev / Eliana Kapitanska / Guenka Petrova / Zornitsa Mitkova / Maria Dimitrova

    Frontiers in Public Health, Vol

    2023  Band 11

    Abstract: IntroductionBreast cancer is the most common type of cancer affecting women in Europe. Advanced breast cancer (ABC) poses a significant therapeutic challenge, and therefore, timely access to treatment is crucial. The aim of the present study was to ... ...

    Abstract IntroductionBreast cancer is the most common type of cancer affecting women in Europe. Advanced breast cancer (ABC) poses a significant therapeutic challenge, and therefore, timely access to treatment is crucial. The aim of the present study was to evaluate the treatment patterns and patients' access to new therapies for ABC in Bulgaria.MethodsWe conducted a retrospective study in the period 2008–2021. Based on the European Medicines Agency (EMA) database, we analyzed a number of medicinal products with marketing authorization for ABC in the last 13 years. Time to market access was evaluated as the degree of availability, which is measured by the number of medicines that are available to patients (availability index, AI), and the average time elapsed between obtaining a marketing authorization and time to inclusion in the Positive Drug List. Data were analyzed through descriptive statistics via Microsoft Excel version 10.ResultsThe average time to access was 564 days for targeted therapy. The availability and compliance index for chemotherapy and hormonal therapy in advanced breast cancer was 1, while the average AI for targeted therapy was 0.67. Patient access to targeted oncology therapy of ABC is above average for Europe and takes 1–2 years.ConclusionFaster access is more evident for biosimilars. National regulatory requirements for pricing and reimbursement have a major impact on market access.
    Schlagwörter advanced breast cancer ; patient access ; targeted therapy ; availability index ; compliance index ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 610
    Sprache Englisch
    Erscheinungsdatum 2023-03-01T00:00:00Z
    Verlag Frontiers Media S.A.
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  6. Artikel ; Online: Review of medicine utilization for Parkinson’s disease management

    Zornitsa Mitkova / Maria Kamusheva / Dobrinka Kalpachka / Desislava Ignatova / Konstantin Tachkov / Guenka Petrova

    Journal of Public Health Research (2021)

    the Bulgarian perspective

    2021  

    Abstract: Background: Parkinson’s disease (PD), which occurs in 1% of the population, is the second most common neurodegenerative disorder. Despite the broad spectrum of PD manifestations and high disease prevalence, there are insufficient data on medicine ... ...

    Abstract Background: Parkinson’s disease (PD), which occurs in 1% of the population, is the second most common neurodegenerative disorder. Despite the broad spectrum of PD manifestations and high disease prevalence, there are insufficient data on medicine utilization and prescription strategies. The purpose of the current study was to analyze published data concerning treatment approaches and to compare them with Bulgarian therapeutic practice. Design and methods: We conducted a systematic review of the PubMed and Google Scholar databases, and we calculated medicine utilization in Bulgaria during 2018 and 2019 using the WHO methodology. Results: The literature search identified a total of 311 publications, but only 12 met the inclusion criteria. Eleven studies pointed out that levodopa-containing medicine are the most frequently used, followed by dopamine agonists. The highest rate was found for levodopa-containing products and decarboxylase inhibitor (1.06 and 1.33 DDD/1000 inh/day), followed by anticholinergic Biperiden (0.494 and 0.455 DDD/1000 inh/day) during 2018 and 2019 in Bulgaria. Conclusion: Overall, the treatment approaches used in the last decade comply with guideline recommendations, despite variations in levodopa and dopamine agonist utilization. Even though new medicines have been approved for PD management, levodopa-containing products are still most often prescribed and used worldwide.
    Schlagwörter Parkinson’s disease ; antiparkinson medicines ; utilization ; Bulgaria ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 306
    Sprache Englisch
    Erscheinungsdatum 2021-08-01T00:00:00Z
    Verlag PAGEPress Publications
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  7. Artikel ; Online: Budget cap and pay-back model to control spending on medicines

    Zornitsa Mitkova / Maria Dimitrova / Miglena Doneva / Konstantin Tachkov / Maria Kamusheva / Lyubomir Marinov / Nikolay Gerasimov / Dimitar Tcharaktchiev / Guenka Petrova

    Frontiers in Public Health, Vol

    A case study of Bulgaria

    2022  Band 10

    Abstract: Central and Eastern European countries (CEEC) have among the highest rates of increase in healthcare expenditure. External reference pricing, generics and biologics price capping, regressive scale for price setting, health technology assessment (HTA), ... ...

    Abstract Central and Eastern European countries (CEEC) have among the highest rates of increase in healthcare expenditure. External reference pricing, generics and biologics price capping, regressive scale for price setting, health technology assessment (HTA), and positive drug lists for reimbursed medicines are among the variety of implemented cost-containment measures aimed at reducing and controlling the rising cost for pharmaceuticals. The aim of our study was to analyze the influence of a recently introduced measure in Bulgaria—budget capping in terms of overall budget expenditure. A secondary goal was to analyze current and extrapolate future trends in the healthcare and pharmaceutical budget based on data from 2016 to 2021. The study is a retrospective, observational and prognostic, macroeconomic analysis of the National Health Insurance Fund's (NHIF) budget before (2016–2018) and after (2019–2021) the introduction of the new budget cap model. Subgroups analysis for each of the three new budget groups of medicines (group A: medicines for outpatient treatment, prescribed after approval by a committee of 3 specialists; group B: all other medicines out of group A; and group C: oncology and life-saving medicines out of group A) was also performed, and the data were extrapolated for the next 3 years. The Kruskal–Wallis test was applied to establish statistically significant differences between the groups. During 2016–2021, healthcare services and pharmaceutical spending increased permanently, observing a growth of 82 and 80%, respectively. The overall healthcare budget increased from European €1.8 billion to 3.3 billion. The subgroup analysis showed a similar trend for all three groups, with similar growth between them. The highest spending was observed in group C, which outpaced the others mainly due to the particular antineoplastic (chemotherapy) medicines included in it. The rising overall healthcare cost in Bulgaria (from European €1.8 billion to 3.3 billion) reveals that implementation of a mechanism for budget ...
    Schlagwörter budget cap ; healthcare budget ; medicines budget ; overspending ; paid back ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 796
    Sprache Englisch
    Erscheinungsdatum 2022-11-01T00:00:00Z
    Verlag Frontiers Media S.A.
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  8. Artikel ; Online: Comparison of Cardiovascular Medicines Prices in Four European Countries

    Zornitsa Mitkova / Mariya Vasileva / Alexandra Savova / Manoela Manova / Silvia Terezova / Guenka Petrova

    Frontiers in Public Health, Vol

    2020  Band 8

    Abstract: The aim of the current study was to compare pricing methodologies at the manufacturer, wholesale, and retail levels, and to estimate the price differences of AT1-receptor blockers (sartans), Angiotensin-converting enzyme (ACE)—inhibitors, and their fixed- ...

    Abstract The aim of the current study was to compare pricing methodologies at the manufacturer, wholesale, and retail levels, and to estimate the price differences of AT1-receptor blockers (sartans), Angiotensin-converting enzyme (ACE)—inhibitors, and their fixed-dose combinations (FDCs) in four countries using similar methodologies: Slovakia, Greece, Bulgaria, and Romania (SK, GR, BG, and RO, respectively). The methodologies for manufacturer, wholesale, and retail price establishment have been compared using nationally implemented rules. Overlapping trademarks were established retrospectively on the manufacturer and retail levels in November 2017. The average price per tablet, percentage of price deviation, and statistically significant differences were calculated. The selected countries apply external reference pricing at the manufacturer level. A wide variation in the number of referent countries was observed (from 12 to 27). Despite the use of a regressive scale for price calculation, large variations between margins and value-added tax (VAT) are established, thus leading to different final medicine prices. This study found that medicine prices were lower in RO than in other selected countries. It was caused by the fact that 15 products had the lowest manufacturer price and 14 products had the lowest retail price in RO. Results of Kruskal–Wallis test showed that there were no significant differences between prices per tablet on the manufacturer and retail levels. In the group of fixed-dose combinations, ramipril/hydrochlorothiazide, and irbesartan/hydrochlorothiazide showed more than 100% deviation. The prices of cardiovascular medicines differed within the observed countries. The differences in pricing methodologies (e.g., margins, VAT) at the national level did not significantly affect retail prices, as a low manufacturer price usually leads to a low retail price.
    Schlagwörter ACE- inhibitors ; AT1-receptor blockers ; manufacturer price ; retail price ; price difference ; Public aspects of medicine ; RA1-1270
    Sprache Englisch
    Erscheinungsdatum 2020-08-01T00:00:00Z
    Verlag Frontiers Media S.A.
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  9. Artikel ; Online: Аn affordability of statins therapy - comparative analysis between Ukraine and Bulgaria

    Oksana Tkachova / Larysa Iakovlieva / Zornitsa Mitkova / Manoela Manova / Alexandra Savova / Guenka Petrova

    BMC Health Services Research, Vol 19, Iss 1, Pp 1-

    2019  Band 8

    Abstract: Abstract Background The statins are а developing group of cardiovascular medicines, widely used for dyslipidemia. As a whole statins consumption leads to reduction in cardiovascular events and death, and improves the disease control. The main study issue ...

    Abstract Abstract Background The statins are а developing group of cardiovascular medicines, widely used for dyslipidemia. As a whole statins consumption leads to reduction in cardiovascular events and death, and improves the disease control. The main study issue considers the differences in an affordability to lipid lowering medicines in the countries with the highest morbidity and mortally rate within and outside EU. The affordability has been researched by exploring the price differences and average wages. Methods On total 7 international nonproprietary names and 19 dosage forms available on both markets are observed during 2013–2016. An average, minimum, and maximum retail prices per DDD, standard deviation (SD) has been calculated for all marketed dosage forms. A price ratio between the minimal and maximal price per DDD is estimated in order to evaluate their difference. Affordability of the treatment is determined as the number of working hours per month needed for patient to purchase medicines for a monthly therapy. Results Large variations of price per DDD, SD and the average price exist between different dosage forms in both countries. The highest value of a price ratio is observed for 5 mg rosuvastatin in Bulgaria and 10 mg rosuvastatin in Ukraine. The number of working hours needed to cover monthly therapy has increased during 2013–2016 in Ukraine. The most affordable is treatment with a generic atorvastatin in Bulgaria and generic rosuvastatin in Ukraine. The most expensive rosuvastatin in Bulgaria and atorvastatin in Ukraine are found as the least affordable for a monthly therapy. Conclusions The decrease of prices for statins is not the only reason influencing patients’ affordability to therapy for statin therapy in Ukraine and Bulgaria. The difference in affordability in Ukraine and Bulgaria is affected mainly by the economic development in the country as well as wages variation.
    Schlagwörter Statins ; Prices per DDD ; Affordability ; Bulgaria ; Ukraine ; Public aspects of medicine ; RA1-1270
    Thema/Rubrik (Code) 320 ; 339
    Sprache Englisch
    Erscheinungsdatum 2019-11-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  10. Artikel ; Online: Life expectancy and survival analysis of patients with diabetes compared to the non diabetic population in Bulgaria.

    Konstantin Tachkov / Konstantin Mitov / Yordanka Koleva / Zornitsa Mitkova / Maria Kamusheva / Maria Dimitrova / Valentina Petkova / Alexandra Savova / Miglena Doneva / Dimitar Tcarukciev / Vasil Valov / Galia Angelova / Manoela Manova / Guenka Petrova

    PLoS ONE, Vol 15, Iss 5, p e

    2020  Band 0232815

    Abstract: AIMS:To evaluate the expected life expectancy in patients with diabetes in Bulgaria and to compare it to the expected life expectancy of the non-diabetic population in the country. METHODS:It is a retrospective observational population study on ... ...

    Abstract AIMS:To evaluate the expected life expectancy in patients with diabetes in Bulgaria and to compare it to the expected life expectancy of the non-diabetic population in the country. METHODS:It is a retrospective observational population study on individuals diagnosed with diabetes, compared to the non-diabetic population in Bulgaria for the period 2012-2015. Data from the national diabetes register and national statistical institute were used to construct life-tables with probability of survival with t-test and Chi Square test. Confounder analysis was done by age, sex, and type of diabetes. All-cause mortality and deaths in diabetic patients were analyzed. Kaplan-Meier survival curves were constructed for each age group and a log-rank analysis was conducted. RESULTS:Average life expectancy in the non-diabetic population, patients with Type 1 DM and with Type 2 DM is 74.8; 70.96 and 75.19 years, respectively. For 2012-2015 the mortality in the non-diabetic population remained constant and lower (average-1.48%) compared to type-1 DM (5.25%) and Type-2 (4.27%). Relative risk of death in diabetics was higher overall (12%), after the age of 70 before which the relative risk was higher for the non-diabetic population. This was observed as a trend in all analyzed years. CONCLUSION:Patients with type 2 DM have a longer life-expectancy than patients with type-1 DM and overall Diabetics life expectancy equals that of the non-diabetic population, which could suggest improved disease control and its associated complications in Bulgaria. Male diabetics show slightly longer life expectancy than their counterparts in the non-diabetic population, by a marginal gain of 0.6 years for the entire observed period. Life expectancy in diabetic women increased by 1.3 years, which was not observed in the non-diabetic population. Prevalence of diabetes was higher for women. Improved diabetes control may explain this gain in life; however other studies are needed to confirm this.
    Schlagwörter Medicine ; R ; Science ; Q
    Sprache Englisch
    Erscheinungsdatum 2020-01-01T00:00:00Z
    Verlag Public Library of Science (PLoS)
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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