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The EMA assessment of pembrolizumab as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer

• Authors : Trullas, Ana; Delgado, Juan; Genazzani, Armando

Subjects: MSI-high; colorectal cancer; Monoklonaler Antikörper

• Source: ESMO open, 6(3):100145

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Allergen Immunotherapy (AIT) in children: a vulnerable population with its own rights and legislation - summary of EMA-initiated multi-stakeholder meeting on Allergen Immunotherapy (AIT) for children, held at Paul-Ehrlich-Institut, Langen, Germany, 16.1.2019

• Authors : Mahler, Vera; Mentzer, Dirk; Bonertz, Andreas

Subjects: European Medicines Agency (EMA); Allergie; Paediatric Investigation Plan (PIP)

• Source: Clinical and translational allergy, 10:28

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Umgang mit vertraulichen Daten für CTIS – Blick auf einen EMA Leitlinien-Entwurf

• Authors : Yazdanparast, Haniyeh

• Source: PM QM, 25(1):8-11

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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

• Authors : van der Laan, Jan Willem; Andersson, Mikael; Beken, Sonja

Subjects: 3Rs; human pharmaceuticals; regulatory assessment

• Source: British journal of clinical pharmacology, Supplement, 89(8):2341–2348

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The FeverApp registry – ecological momentary assessment (EMA) of fever management in families regarding conformity to up-to-date recommendations

• Authors : Martin, David; Wachtmeister, Jana; Ludwigs, Kai

Subjects: Antipyretics; Study Protocol; Ecological Momentary Assessment [MeSH]

• Source: http://lobid.org/resources/99370673400706441#!, 20(1):249.

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The European Medicines Agency review of the initial application of atezolizumab and the role of PD-L1 expression as biomarker for checkpoint inhibitors

• Authors : Araujo-Fernandez, I.; Delgado, J.; Moscetti, L.

Subjects: TECENTRIQ; EMA; Monoklonaler Antikörper

• Source: ESMO open, 6(1):100008

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Daily Worry in Trauma-Exposed Afghan Refugees: Relationship with Affect and Sleep in a Study Using Ecological Momentary Assessment

• Authors : Koch, Theresa; Liedl, Alexandra; Takano, Keisuke

Subjects: Original Article; Worry; EMA

• Source: http://lobid.org/resources/99370675661906441#!, 44(3):645-658.

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Early conscious prone positioning in patients with COVID-19 receiving continuous positive airway pressure: a retrospective analysis

• Authors : Winearls, Stuart; Swingwood, Ema L; Hardaker, Charlotte L

Subjects: COVID-19; ARDS; viral infection

• Source: BMJ Open Respiratory Research, 7:e000711

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Das EU-Portal: Aufgaben, Bedeutung, Funktion

• Authors : Aschen, Harald von; Krafft, Hartmut

Subjects: EU regulation No. 536/2014; EMA; EU Portal

• Source: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 60:812–816

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Directions for new developments on statistical design and analysis of small population group trials

• Authors : Hilgers, Ralf-Dieter; Roes, Kit; Stallard, Nigel

Subjects: Statistical analysis; Small population clinical trials; Rare disease

• Source: Orphanet journal of rare diseases, 11:78

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