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  1. Book ; Thesis: Die ösophageale Histologie bei Kindern mit reflux-assoziierten chronischen pulmonalen Störungen

    Hartenstein, Diana

    2000  

    Author's details vorgelegt von Diana Hartenstein
    Language German
    Size II, 96 S., Ill., graph. Darst., 21 cm
    Publishing country Germany
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Frankfurt (Main), Univ., Diss., 2000
    HBZ-ID HT013164465
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

    Shelf markLoan statusLocation
    2001 D 2356 order for loan Magazin

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  2. Article: Comparison of allergen immunotherapy practice patterns in inhalant allergies in the United States of America and Europe: Similarities and differences 2023.

    Pfaar, Oliver / Becker, Sven / Calabria, Christopher / Hartenstein, Diana / Jung, Jenna / Zimmer, Julia / Ponda, Punita

    The World Allergy Organization journal

    2023  Volume 16, Issue 5, Page(s) 100766

    Abstract: IgE-mediated atopic diseases such as allergic rhinitis and rhinoconjunctivitis are common chronic diseases in the western world. Allergen immunotherapy (AIT) plays a fundamental role in the treatment of allergic patients by modulating the underlying ... ...

    Abstract IgE-mediated atopic diseases such as allergic rhinitis and rhinoconjunctivitis are common chronic diseases in the western world. Allergen immunotherapy (AIT) plays a fundamental role in the treatment of allergic patients by modulating the underlying immune mechanisms. Though this treatment is integrated in practice-patterns globally, many differences are found in the application of AIT on the national or international level due to heterogeneous methods, and clinical recommendations are given in different parts of the world. This review from authors in Europe and the United States highlights differences and similarities in important aspects of AIT application in the 2 global regions. First, the regulatory situation differs regarding marketing authorization and licensing. Secondly, differences are elaborated in manufacturing practices, marketing distribution and formulations of AIT products. Thirdly, clinical administration patterns in the current guidelines show similarities in indications and contraindications of AIT, but also are divergent in some practical aspects. Informing the readership on similarities, as well as differences of standards in AIT in the United States and Europe, the authors highlight the unmet need of thorough harmonization of standards of AIT, as it is the only disease modifying treatment option available for patients with allergic rhinitis and rhinoconjunctivitis.
    Language English
    Publishing date 2023-05-24
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2581968-9
    ISSN 1939-4551
    ISSN 1939-4551
    DOI 10.1016/j.waojou.2023.100766
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy.

    Pfaar, Oliver / Hamelmann, Eckard / Taube, Christian / Wagenmann, Martin / Wedi, Bettina / Werfel, Thomas / Bartel, Detlef / Bonertz, Andreas / Hartenstein, Diana / Kaul, Susanne / Mahler, Vera / Worm, Margitta

    Allergologie select

    2023  Volume 7, Page(s) 229–235

    Abstract: A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory ... ...

    Abstract A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory framework under the transitional provision of the Therapy Allergen Ordinance (TAO), and the consequences for the planned guideline work of the DGAKI, regulatory challenges in the approval of AIT products for children and adolescents as well as allergy diagnostics. The content and discussion points of this dialogue are summarized and are set in context with the current literature.
    Language English
    Publishing date 2023-12-12
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2893503-2
    ISSN 2512-8957 ; 2512-8957
    ISSN (online) 2512-8957
    ISSN 2512-8957
    DOI 10.5414/ALX02450E
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Allergen-specific immunotherapy and evidence: A European regulatory perspective.

    Bartel, Detlef / Bonertz, Andreas / Hartenstein, Diana / Kaul, Stefan / Lauer, Iris / Reeb, Christina / Rösner-Friese, Karen / Sliva, Katja / Zimmer, Julia / Vieths, Stefan / Mahler, Vera

    Allergologie select

    2023  Volume 7, Page(s) 198–210

    Abstract: Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory ... ...

    Abstract Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.
    Language English
    Publishing date 2023-12-12
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 2893503-2
    ISSN 2512-8957 ; 2512-8957
    ISSN (online) 2512-8957
    ISSN 2512-8957
    DOI 10.5414/ALX02413E
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Book ; Thesis: Die ösophageale Histologie bei Kindern mit reflux-assoziierten chronischen pulmonalen Störungen

    Hartenstein, Diana

    2000  

    Author's details vorgelegt von Diana Hartenstein
    Language German
    Size II, 96 S, Ill., graph. Darst, 21 cm
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Univ., Diss--Frankfurt (Main), 2000
    Database Former special subject collection: coastal and deep sea fishing

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  6. Article ; Online: Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA).

    Khaleva, Ekaterina / Rattu, Anna / Brightling, Chris / Bush, Andrew / Bossios, Apostolos / Bourdin, Arnaud / Chung, Kian Fan / Chaudhuri, Rekha / Coleman, Courtney / Dahlén, Sven-Erik / Djukanovic, Ratko / Deschildre, Antoine / Fleming, Louise / Fowler, Stephen J / Gupta, Atul / Hamelmann, Eckard / Hashimoto, Simone / Hedlin, Gunilla / Koppelman, Gerard H /
    Melén, Erik / Murray, Clare S / Pilette, Charles / Porsbjerg, Celeste / Pike, Katharine C / Rusconi, Franca / Williams, Clare / Ahrens, Birgit / Alter, Peter / Anckers, Freja / van den Berge, Maarten / Blumchen, Katharina / Brusselle, Guy / Clarke, Graham W / Cunoosamy, Danen / Dahlén, Barbro / Dixey, Piers / Exley, Andrew / Frey, Urs / Gaillard, Erol A / Giovannini-Chami, Lisa / Grigg, Jonathan / Hartenstein, Diana / Heaney, Liam G / Karadag, Bülent / Kaul, Susanne / Kull, Inger / Licari, Amelia / Maitland-van der Zee, Anke H / Mahler, Vera / Schoos, Ann-Marie M / Nagakumar, Prasad / Negus, Jenny / Nielsen, Hanna / Paton, James / Pijnenburg, Mariëlle / Ramiconi, Valeria / Romagosa Vilarnau, Sofia / Principe, Stefania / Rutjes, Niels / Saglani, Sejal / Seddon, Paul / Singer, Florian / Staudinger, Heribert / Turner, Steve / Vijverberg, Susanne / Winders, Tonya / Yasinska, Valentyna / Roberts, Graham

    The European respiratory journal

    2023  Volume 61, Issue 4

    Abstract: Background: Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to ... ...

    Abstract Background: Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.
    Methods: COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult and paediatric clinicians, pharmaceutical representatives, and health regulators from across Europe. Evidence included a systematic review of development, validity and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients' and carers' views about outcome measures. It was discussed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.
    Results: Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV
    Conclusions: This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.
    MeSH term(s) Child ; Humans ; Adult ; Quality of Life ; Reproducibility of Results ; Disease Progression ; Asthma/drug therapy ; Outcome Assessment, Health Care ; Anti-Asthmatic Agents/therapeutic use
    Chemical Substances Anti-Asthmatic Agents
    Language English
    Publishing date 2023-04-03
    Publishing country England
    Document type Systematic Review ; Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.00606-2022
    Database MEDical Literature Analysis and Retrieval System OnLINE

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