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  1. AU="Christopher B Fox"
  2. AU="Joseph J. Lieber MD"
  3. AU="Hasan Aykut Tuncer"
  4. AU="Mayar Allam"
  5. AU=Merckx Joanna AU=Merckx Joanna
  6. AU="Rostásy, K"
  7. AU=Golar Golar AU=Golar Golar
  8. AU="Marcolin, Alessandra Cristina"
  9. AU="Scharer, Mirah"
  10. AU="Freeman, Andrew M"
  11. AU="Chalkley, E"
  12. AU="Wong, Xianrong"
  13. AU="Akamatsu, Akira"
  14. AU="Richardson, Carrie"
  15. AU="Subudhi, Amit K"
  16. AU="Rebecca Moore"
  17. AU="Pagali, Sandeep"
  18. AU="Sun, Lova"
  19. AU="Etienne, Z. B."

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  1. Artikel ; Online: Squalene Emulsions for Parenteral Vaccine and Drug Delivery

    Christopher B. Fox

    Molecules, Vol 14, Iss 9, Pp 3286-

    2009  Band 3312

    Abstract: Squalene is a linear triterpene that is extensively utilized as a principal component of parenteral emulsions for drug and vaccine delivery. In this review, the chemical structure and sources of squalene are presented. Moreover, the physicochemical and ... ...

    Abstract Squalene is a linear triterpene that is extensively utilized as a principal component of parenteral emulsions for drug and vaccine delivery. In this review, the chemical structure and sources of squalene are presented. Moreover, the physicochemical and biological properties of squalene-containing emulsions are evaluated in the context of parenteral formulations. Historical and current parenteral emulsion products containing squalene or squalane are discussed. The safety of squalene-based products is also addressed. Finally, analytica techniques for characterization of squalene emulsions are examined.
    Schlagwörter squalene ; squalane ; adjuvant ; emulsion ; parenteral ; Organic chemistry ; QD241-441
    Sprache Englisch
    Erscheinungsdatum 2009-09-01T00:00:00Z
    Verlag MDPI AG
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  2. Artikel ; Online: Stressed stability and protective efficacy of lead lyophilized formulations of ID93+GLA-SE tuberculosis vaccine

    Michelle C. Archer / Joseph McCollum / Christopher Press / Timothy S. Dutill / Hong Liang / Dawn Fedor / Liam Kapilow-Cohen / Alana Gerhardt / Tony Phan / Edward H. Trappler / Mark T. Orr / Ryan M. Kramer / Christopher B. Fox

    Heliyon, Vol 9, Iss 6, Pp e17325- (2023)

    2023  

    Abstract: With the recent exception of coronavirus disease 2019 (COVID-19), tuberculosis (TB) causes more deaths globally than any other infectious disease, and approximately 1/3 of the world's population is infected with Mycobacterium tuberculosis (Mtb). However, ...

    Abstract With the recent exception of coronavirus disease 2019 (COVID-19), tuberculosis (TB) causes more deaths globally than any other infectious disease, and approximately 1/3 of the world's population is infected with Mycobacterium tuberculosis (Mtb). However, encouraging progress in TB vaccine development has been reported, with approximately 50% efficacy achieved in Phase 2b clinical testing of an adjuvanted subunit TB vaccine candidate. Nevertheless, current lead vaccine candidates require cold-chain transportation and storage. In addition to temperature stress, vaccines may be subject to several other stresses during storage and transport, including mechanical, photochemical, and oxidative stresses. Optimal formulations should enable vaccine configurations with enhanced stability and decreased sensitivity to physical and chemical stresses, thus reducing reliance on the cold chain and facilitating easier worldwide distribution. In this report, we describe the physicochemical stability performance of three lead thermostable formulations of the ID93 + GLA-SE TB vaccine candidate under various stress conditions. Moreover, we evaluate the impact of thermal stress on the protective efficacy of the vaccine formulations. We find that formulation composition impacts stressed stability performance, and our comprehensive evaluation enables selection of a lead single-vial lyophilized candidate containing the excipient trehalose and Tris buffer for advanced development.
    Schlagwörter ID93 ; GLA-SE ; Thermostability ; Cold chain ; Vaccine formulation ; Lyophilization ; Science (General) ; Q1-390 ; Social sciences (General) ; H1-99
    Sprache Englisch
    Erscheinungsdatum 2023-06-01T00:00:00Z
    Verlag Elsevier
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  3. Artikel ; Online: A molecular atlas of innate immunity to adjuvanted and live attenuated vaccines, in mice

    Audrey Lee / Madeleine K. D. Scott / Florian Wimmers / Prabhu S. Arunachalam / Wei Luo / Christopher B. Fox / Mark Tomai / Purvesh Khatri / Bali Pulendran

    Nature Communications, Vol 13, Iss 1, Pp 1-

    2022  Band 13

    Abstract: Adjuvants provide additional impetus for the immune response to vaccination regimens, however their modes of activity and impact on particular compartments of the immune response are currently not well understood. Here the authors perform high resolution ...

    Abstract Adjuvants provide additional impetus for the immune response to vaccination regimens, however their modes of activity and impact on particular compartments of the immune response are currently not well understood. Here the authors perform high resolution assessment of the immune response to a well-established vaccination model and show innate immune transcriptomic and epigenomic alterations of innate cells in the lymph nodes following vaccination.
    Schlagwörter Science ; Q
    Sprache Englisch
    Erscheinungsdatum 2022-01-01T00:00:00Z
    Verlag Nature Portfolio
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  4. Artikel: New generation adjuvants – From empiricism to rational design

    O’Hagan, Derek T / Christopher B. Fox

    Vaccine. 2015 June 08, v. 33

    2015  

    Abstract: Adjuvants are an essential component of modern vaccine development. Despite many decades of development, only a few types of adjuvants are currently included in vaccines approved for human use. In order to better understand the reasons that development ... ...

    Abstract Adjuvants are an essential component of modern vaccine development. Despite many decades of development, only a few types of adjuvants are currently included in vaccines approved for human use. In order to better understand the reasons that development of some adjuvants succeeded while many others failed, we discuss some of the common attributes of successful first generation adjuvants. Next, we evaluate current trends in the development of second generation adjuvants, including the potential advantages of rationally designed synthetic immune potentiators appropriately formulated. Finally, we discuss desirable attributes of next generation adjuvants. Throughout, we emphasize that the importance of formulation and analytical characterization in all aspects of vaccine adjuvant development is often underappreciated. We highlight the formulation factors that must be evaluated in order to optimize interactions between vaccine antigens, immune potentiators, and particulate formulations, and the resulting effects on safety, biological activity, manufacturability, and stability.
    Schlagwörter adjuvants ; antigens ; bioactive properties ; humans ; vaccine development ; vaccines
    Sprache Englisch
    Erscheinungsverlauf 2015-0608
    Umfang p. B14-B20.
    Erscheinungsort Elsevier Ltd
    Dokumenttyp Artikel
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2015.01.088
    Datenquelle NAL Katalog (AGRICOLA)

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  5. Artikel ; Online: Early Post-Vaccination Gene Signatures Correlate With the Magnitude and Function of Vaccine-Induced HIV Envelope-Specific Plasma Antibodies in Infant Rhesus Macaques

    K. K. Vidya Vijayan / Kaitlyn A. Cross / Alan D. Curtis / Koen K. A. Van Rompay / Justin Pollara / Christopher B. Fox / Mark Tomai / Tomáš Hanke / Genevieve Fouda / Michael G. Hudgens / Sallie R. Permar / Kristina De Paris

    Frontiers in Immunology, Vol

    2022  Band 13

    Abstract: A better understanding of the impact of early innate immune responses after vaccine priming on vaccine-elicited adaptive immune responses could inform rational design for effective HIV vaccines. The current study compared the whole blood molecular immune ...

    Abstract A better understanding of the impact of early innate immune responses after vaccine priming on vaccine-elicited adaptive immune responses could inform rational design for effective HIV vaccines. The current study compared the whole blood molecular immune signatures of a 3M-052-SE adjuvanted HIV Env protein vaccine to a regimen combining the adjuvanted Env protein with simultaneous administration of a modified Vaccinia Ankara vector expressing HIV Env in infant rhesus macaques at days 0, 1, and 3 post vaccine prime. Both vaccines induced a rapid innate response, evident by elevated inflammatory plasma cytokines and altered gene expression. We identified 25 differentially-expressed genes (DEG) on day 1 compared to day 0 in the HIV protein vaccine group. In contrast, in the group that received both the Env protein and the MVA-Env vaccine only two DEG were identified, implying that the MVA-Env modified the innate response to the adjuvanted protein vaccine. By day 3, only three DEG maintained altered expression, indicative of the transient nature of the innate response. The DEG represented immune pathways associated with complement activation, type I interferon and interleukin signaling, pathogen sensing, and induction of adaptive immunity. DEG expression on day 1 was correlated to Env-specific antibody responses, in particular antibody-dependent cytotoxicity responses at week 34, and Env-specific follicular T helper cells. Results from network analysis supported the interaction of DEG and their proteins in B cell activation. These results emphasize that vaccine-induced HIV-specific antibody responses can be optimized through the modulation of the innate response to the vaccine prime.
    Schlagwörter systems biology ; innate gene signatures ; vaccine-induced antibody response ; early life HIV vaccine ; rhesus macaque model ; Immunologic diseases. Allergy ; RC581-607
    Thema/Rubrik (Code) 570
    Sprache Englisch
    Erscheinungsdatum 2022-04-01T00:00:00Z
    Verlag Frontiers Media S.A.
    Dokumenttyp Artikel ; Online
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  6. Artikel ; Online: Prophylactic efficacy against Mycobacterium tuberculosis using ID93 and lipid-based adjuvant formulations in the mouse model.

    Susan L Baldwin / Valerie A Reese / Sasha E Larsen / Elyse Beebe / Jeff Guderian / Mark T Orr / Christopher B Fox / Steven G Reed / Rhea N Coler

    PLoS ONE, Vol 16, Iss 3, p e

    2021  Band 0247990

    Abstract: An estimated 10 million people developed tuberculosis (TB) disease in 2019 which underscores the need for a vaccine that prevents disease and reduces transmission. The aim of our current studies is to characterize and test a prophylactic tuberculosis ... ...

    Abstract An estimated 10 million people developed tuberculosis (TB) disease in 2019 which underscores the need for a vaccine that prevents disease and reduces transmission. The aim of our current studies is to characterize and test a prophylactic tuberculosis vaccine comprised of ID93, a polyprotein fusion antigen, and a liposomal formulation [including a synthetic TLR4 agonist (glucopyranosyl lipid adjuvant, GLA) and QS-21] in a preclinical mouse model of TB disease. Comparisons of the ID93+GLA-LSQ vaccines are also made to the highly characterized ID93+GLA-SE oil-in-water emulsion adjuvant, which are also included these studies. The recent success of vaccine candidate M72 combined with adjuvant AS01E (GlaxoSmithKline Biologicals) in reducing progression to active disease is promising and has renewed excitement for experimental vaccines currently in the TB vaccine pipeline. The AS01E adjuvant contains monophosphoryl lipid A (MPL) and QS-21 (a saponin) in a liposomal formulation. While AS01E has demonstrated potent adjuvant activity as a component of both approved and experimental vaccines, developing alternatives to this adjuvant system will become important to fill the high demand envisioned for future vaccine needs. Furthermore, replacement sources of potent adjuvants will help to supply the demand of a TB vaccine [almost one-quarter of the world's population are estimated to have latent Mycobacterium tuberculosis (Mtb) according to the WHO 2019 global TB report], addressing (a) cost of goods, (b) supply of goods, and (c) improved efficacy of subunit vaccines against Mtb. We show that both ID93+GLA-SE (containing an emulsion adjuvant) and ID93+GLA-LSQ (containing a liposomal adjuvant) induce ID93-specific TH1 cellular immunity including CD4+CD44+ T cells expressing IFNγ, TNF, and IL-2 (using flow cytometry and intracellular cytokine staining) and vaccine-specific IgG2 antibody responses (using an ELISA). In addition, both ID93+GLA-SE and ID93+GLA-LSQ effectively decrease the bacterial load within the lungs of mice ...
    Schlagwörter Medicine ; R ; Science ; Q
    Thema/Rubrik (Code) 630
    Sprache Englisch
    Erscheinungsdatum 2021-01-01T00:00:00Z
    Verlag Public Library of Science (PLoS)
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  7. Artikel ; Online: Controlled Covalent Conjugation of a Tuberculosis Subunit Antigen (ID93) to Liposome Improved In Vitro Th1-Type Cytokine Recall Responses in Human Whole Blood

    Babatunde Ayodeji Adeagbo / Akintunde Oluseto Akinlalu / Tony Phan / Jeff Guderian / Gerhardt Boukes / Elize Willenburg / Caryn Fenner / Oluseye Oladotun Bolaji / Christopher B. Fox

    ACS Omega, Vol 5, Iss 48, Pp 31306-

    2020  Band 31313

    Schlagwörter Chemistry ; QD1-999
    Sprache Englisch
    Erscheinungsdatum 2020-11-01T00:00:00Z
    Verlag American Chemical Society
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  8. Artikel ; Online: Squalene Emulsion Manufacturing Process Scale-Up for Enhanced Global Pandemic Response

    Tony Phan / Christian Devine / Erik D. Laursen / Adrian Simpson / Aaron Kahn / Amit P. Khandhar / Steven Mesite / Brad Besse / Ken J. Mabery / Elizabeth I. Flanagan / Christopher B. Fox

    Pharmaceuticals, Vol 13, Iss 168, p

    2020  Band 168

    Abstract: Squalene emulsions are among the most widely employed vaccine adjuvant formulations. Among the demonstrated benefits of squalene emulsions is the ability to enable vaccine antigen dose sparing, an important consideration for pandemic response. In order ... ...

    Abstract Squalene emulsions are among the most widely employed vaccine adjuvant formulations. Among the demonstrated benefits of squalene emulsions is the ability to enable vaccine antigen dose sparing, an important consideration for pandemic response. In order to increase pandemic response capabilities, it is desirable to scale up adjuvant manufacturing processes. We describe innovative process enhancements that enabled the scale-up of bulk stable squalene emulsion (SE) manufacturing capacity from a 3000- to 5,000,000-dose batch size. Manufacture of concentrated bulk along with the accompanying viscosity change in the continuous phase resulted in a ≥25-fold process efficiency enhancement. Process streamlining and implementation of single-use biocontainers resulted in reduced space requirements, fewer unit operations, and minimization of cleaning requirements. Emulsion physicochemical characteristics were measured by dynamic light scattering, laser diffraction, and HPLC with charged aerosol detection. The newly developed full-scale process was demonstrated by producing two 5,000,000-dose batches of bulk concentrated SE. A scale-up of adjuvant manufacturing capacity through process innovation enables more efficient production capabilities for pandemic response.
    Schlagwörter squalene emulsion ; vaccine adjuvant ; nanoemulsion ; process scale-up ; emulsion manufacturing ; adjuvant manufacturing ; Medicine ; R ; Pharmacy and materia medica ; RS1-441
    Thema/Rubrik (Code) 670
    Sprache Englisch
    Erscheinungsdatum 2020-07-01T00:00:00Z
    Verlag MDPI AG
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  9. Artikel: Nanoformulation of synergistic TLR ligands to enhance vaccination against Entamoeba histolytica

    Abhyankar, Mayuresh M / Christopher B. Fox / James Elvecrog / Mark A. Tomai / William A. Petri / Zannatun Noor

    Vaccine. 2017 Feb. 07, v. 35, no. 6

    2017  

    Abstract: Diarrheal infectious diseases represent a major cause of global morbidity and mortality. There is an urgent need for vaccines against diarrheal pathogens, especially parasites. Modern subunit vaccines rely on combining a highly purified antigen with an ... ...

    Abstract Diarrheal infectious diseases represent a major cause of global morbidity and mortality. There is an urgent need for vaccines against diarrheal pathogens, especially parasites. Modern subunit vaccines rely on combining a highly purified antigen with an adjuvant to increase their efficacy. In the present study, we evaluated the ability of a nanoliposome adjuvant system to trigger a strong mucosal immune response to the Entamoeba histolytica Gal/GalNAc lectin LecA antigen. CBA/J mice were immunized with alum, emulsion or liposome based formulations containing synthetic TLR agonists. A liposome formulation containing TLR4 and TLR7/8 agonists was selected based on its ability to generate intestinal IgA, plasma IgG2a/IgG1, IFN-γ and IL-17A. Immunization with a mucosal prime followed by a parenteral boost generated a high mucosal IgA response that inhibited adherence of parasites to mammalian cells. Inclusion of the immune potentiator all-trans retinoic acid in the regimen further improved the mucosal IgA response. Immunization protected from infection with up to 55% efficacy. Our results show that a nanoliposome delivery system containing TLR agonists is a promising prospect for the development of vaccines against enteric pathogens, especially when a multifaceted immune response is desired.
    Schlagwörter adjuvants ; agonists ; alum ; antigens ; diarrhea ; emulsions ; Entamoeba histolytica ; enteropathogens ; immune response ; immunoglobulin A ; infectious diseases ; interferon-gamma ; interleukin-17 ; lectins ; ligands ; mice ; morbidity ; mortality ; mucosal immunity ; parasites ; retinoic acid ; subunit vaccines ; Toll-like receptor 4 ; vaccination ; vaccine development
    Sprache Englisch
    Erscheinungsverlauf 2017-0207
    Umfang p. 916-922.
    Erscheinungsort Elsevier Ltd
    Dokumenttyp Artikel
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2016.12.057
    Datenquelle NAL Katalog (AGRICOLA)

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    Zs.A 1930: Hefte anzeigen Standort:
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    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 458: Hefte anzeigen

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  10. Artikel ; Online: Preparedness against pandemic influenza

    Milena Apetito Akamatsu / Vitor Anselmo Sakihara / Bianca Pereira Carvalho / Aline de Paiva Abrantes / Maria A Sakauchi Takano / Eduardo Alfredo Adami / Fernando Seiji Yonehara / Patrícia Dos Santos Carneiro / Stefanni Rico / Alessandra Schanoski / Maurício Meros / Adrian Simpson / Tony Phan / Christopher B Fox / Paulo Lee Ho

    PLoS ONE, Vol 15, Iss 6, p e

    Production of an oil-in-water emulsion adjuvant in Brazil.

    2020  Band 0233632

    Abstract: Increasing pandemic influenza vaccine manufacturing capacity is considered strategic by WHO. Adjuvant use is key in this strategy in order to spare the vaccine doses and by increasing immune protection. We describe here the production and stability ... ...

    Abstract Increasing pandemic influenza vaccine manufacturing capacity is considered strategic by WHO. Adjuvant use is key in this strategy in order to spare the vaccine doses and by increasing immune protection. We describe here the production and stability studies of a squalene based oil-in-water emulsion, adjuvant IB160, and the immune response of the H7N9 vaccine combined with IB160. To qualify the production of IB160 we produced 10 consistency lots of IB160 and the average results were: pH 6.4±0.05; squalene 48.8±.0.03 mg/ml; osmolality 47.6±6.9 mmol/kg; Z-average 157±2 nm, with polydispersity index (PDI) of 0.085±0.024 and endotoxin levels <0.5 EU/mL. The emulsion particle size was stable for at least six months at 25°C and 24 months at 4-8°C. Two doses of H7N9 vaccine formulated at 7.5 μg/dose or 15 μg/dose with adjuvant IB160 showed a significant increase of hemagglutination inhibition (HAI) titers in sera of immunized BALB/c mice when compared to control sera from animals immunized with the H7N9 antigens without adjuvant. Thus the antigen-sparing capacity of IB160 can potentially increase the production of the H7N9 pandemic vaccine and represents an important achievement for preparedness against pandemic influenza and a successful North (IDRI) to South (Butantan Institute) technology transfer for the production of the adjuvant emulsion IB160.
    Schlagwörter Medicine ; R ; Science ; Q
    Thema/Rubrik (Code) 630
    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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