يعرض 1 - 10 نتائج من 1,634 نتيجة بحث عن '"the european medicines agency"', وقت الاستعلام: 1.14s تنقيح النتائج
  1. 1
    كتاب إلكتروني
    Analytical Tools for the Characterization of Nasal Spray Drug Products

    المؤلفون: Gondhale-Karpe, PriyankaAff4, Bhope, ShrinivasAff5, Puri, MakarandAff4, Manwatkar, SonaliAff6, Mahajan, BhavnaAff7

    المساهمون: Kulkarni, Shrikaant, editorAff1, Haghi, A. K., editorAff2, Manwatkar, Sonali, editorAff3

    المصدر: Biosystems, Biomedical & Drug Delivery Systems : Characterization, Restoration and Optimization. :61-79

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  2. 2
    كتاب إلكتروني
    Processing of ADRs

    المؤلفون: Roy, SwetaAff3, Nandave, MukeshAff3, Kumar, AnoopAff3

    المساهمون: Nandave, Mukesh, editorAff1, Kumar, Anoop, editorAff2

    المصدر: Pharmacovigilance Essentials : Advances, Challenges and Global Perspectives. :79-109

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  3. 3
    كتاب إلكتروني
    Aggregate Reporting

    المؤلفون: Singh, RimaAff3, Nandave, MukeshAff3, Kumar, AnoopAff3, Pandita, DeeptiAff3

    المساهمون: Nandave, Mukesh, editorAff1, Kumar, Anoop, editorAff2

    المصدر: Pharmacovigilance Essentials : Advances, Challenges and Global Perspectives. :111-125

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  4. 4
    دورية أكاديمية
    Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan

    المؤلفون: Ito, AkiraAff1, Aff2, IDs43441023005773_cor1, Narukawa, Mamoru

    المصدر: Therapeutic Innovation & Regulatory Science. 58(1):136-142

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  5. 5
    دورية أكاديمية
    Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

    المؤلفون: Michaeli, Daniel TobiasAff1, Aff2, IDs1019802301639x_cor1, Michaeli, ThomasAff3, Aff4, Aff5, Albers, Sebastian, Boch, TobiasAff3, Aff4, Aff5, Michaeli, Julia Caroline

    المصدر: The European Journal of Health Economics. :1-19

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  6. 6
    دورية أكاديمية
    A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

    المؤلفون: Ivana Silva, Giulia Gabrielli, Juan Garcia Burgos, Isabelle Moulon, Gonzalo Calvo Rojas, Ulrich Jaeger, Rosa Giuliani

    المصدر: Frontiers in Medicine, Vol 11 (2024)

    مصطلحات موضوعية: European Medicines Agency, stakeholder engagement, healthcare professionals (HCPs), public Health, regulation of medicines, Medicine (General), R5-920

    وصف الملف: electronic resource

    Relation: https://www.frontiersin.org/articles/10.3389/fmed.2024.1399947/full; https://doaj.org/toc/2296-858X

    URL الوصول: https://doaj.org/article/17f4b82d413b4ad68f8995bfc0a89266

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  7. 7
    Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?

    المؤلفون: Chauca Strand, Gabriella, Johansson, Naimi, Jakobsson, Niklas, Professor, 1981, Bonander, Carl, 1988, Svensson, Mikael

    المصدر: Clinical drug investigation. 43(8):621-633

    مصطلحات موضوعية: renal-cell carcinoma, european medicines agency, early breast-cancer, clinical benefit, lung-cancer, phase-III, end-points, open-label, everolimus, outcomes, Economics, Nationalekonomi

    وصف الملف: electronic

    URL الوصول: https://urn.kb.se/resolve?urn=urn:nbn:se:kau:diva-96400
    https://doi.org/10.1007/s40261-023-01285-4
    https://kau.diva-portal.org/smash/get/diva2:1788854/FULLTEXT02.pdf

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  8. 8
    دورية أكاديمية
    Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017–2022

    المؤلفون: Ciani, OrianaAff1, IDs10072023068256_cor1, Meregaglia, Michela, Battaglia, Mario Alberto, Brichetto, Gianpaolo, Conte, AntonellaAff4, Aff5, Aff6, Gasperini, ClaudioAff6, Aff7, Sansone, Valeria

    المصدر: Neurological Sciences. 44(8):2933-2937

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  9. 9
    دورية أكاديمية
    Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

    المؤلفون: Viviana Giannuzzi, Arianna Bertolani, Silvia Torretta, Giorgio Reggiardo, Eleonora Toich, Donato Bonifazi, Adriana Ceci

    المصدر: Frontiers in Medicine, Vol 11 (2024)

    مصطلحات موضوعية: innovative methodologies, pediatric research, regulatory, qualification procedure, European Medicines Agency, Medicine (General), R5-920

    وصف الملف: electronic resource

    Relation: https://www.frontiersin.org/articles/10.3389/fmed.2024.1369547/full; https://doaj.org/toc/2296-858X

    URL الوصول: https://doaj.org/article/8a34c496f14547ed9df7bdb0329ccc41

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  10. 10
    دورية أكاديمية
    Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status

    المؤلفون: K. Boesen, P. C. Gøtzsche, J. P. A. Ioannidis

    المصدر: Epidemiology and Psychiatric Sciences, Vol 33 (2024)

    مصطلحات موضوعية: conflicts of interest, European Medicines Agency, regulatory guidelines, transparency, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Public aspects of medicine, RA1-1270

    وصف الملف: electronic resource

    Relation: https://www.cambridge.org/core/product/identifier/S2045796024000179/type/journal_article; https://doaj.org/toc/2045-7960; https://doaj.org/toc/2045-7979

    URL الوصول: https://doaj.org/article/27198d7b0f094862b51f982284f1b52d

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