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Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment

2024 . Wang, Lu | Golchin, Negar | Klot, Stephanie von | Salinas, Claudia A. | Manlik, Katrin | Patadia, Vaishali | Miller, Mary K. | Asubonteng, Julius | McDermott, Rachel | Barberio, Julie | Gipson, Geoffrey

Leveraging Real-World Data in Safety Signal Assessment

2024 . Patadia, Vaishali | Manlik, Katrin | Gipson, Geoffrey | Willis, Jenna C. | Namuyinga, Ruth | McDermott, Rachel | Shaw, Anita | Miller, Mary K. | Asubonteng, Julius | Golchin, Negar | von Klot, Stephanie

Psychotropic drug-induced adverse drug reactions in 462,661 psychiatric inpatients in relation to age: results from a German drug surveillance program from 1993–2016

2024 . Seifert, Johanna | Reinhard, Matthias Alexander | Bleich, Stefan | Erfurth, Andreas | Greil, Waldemar | Toto, Sermin | Grohmann, Renate | Glocker, Catherine

Safety and Tolerability of Nintedanib in Patients with Fibrosing Interstitial Lung Diseases: Post-marketing Data

2024 . Chaudhuri, Nazia | Azuma, Arata | Sroka-Saidi, Kamila | Erhardt, Elvira | Ritter, Ivana | Harari, Sergio

Clozapine-associated adverse drug reactions in 38,349 psychiatric inpatients: drug surveillance data from the AMSP project between 1993 and 2016

2024 . Bleich, Lene | Grohmann, Renate | Greil, Waldemar | Dabbert, Dominik | Erfurth, Andreas | Toto, Sermin | Seifert, Johanna

Instruments of official communication by regulatory authorities on risks of drug use

2022 . Bergner, Simone | Grüger, Thomas | Huber, Martin | Lütkehermölle, Walburga | Paeschke, Norbert | Palissa, Harriet | Stephan, Kerstin | Cibura, Sabine | Keller-Stanislawski, Brigitte

Arzneimittelnebenwirkungen und Medikationsfehler bei Kindern: Pharmakoepidemiologie und Ansätze der Vermeidung

2022 . Leitzen, Sarah | Kayser, Claudia | Weißmann, K. | Sachs, Bernhardt

Regulatory Measures to Improve the Safety of CAR-T-Cell Treatment

2022 . Berg, Philipp | Schönefeld, Sonja | Ruppert-Seipp, Gabriele | Funk, Markus

Adverse Drug Reactions in Children: Comparison of Reports Collected in a Pharmacovigilance Project Versus Spontaneously Collected ADR Reports

2022 . Leitzen, Sarah | Dubrall, Diana | Toni, Irmgard | Stingl, Julia | Christ, Patrick | Köberle, Ursula | Schmid, Matthias | Neubert, Antje | Sachs, Bernhardt

Harmonization of summaries of product characteristics (SmPCs) of drugs with the same active ingredients: an evaluation of SmPCs of the most frequently prescribed active substances

2021 . Gahr, Maximilian | Connemann, Bernhard J. | Muche, Rainer | Zeiss, René | Wolf, Almuth

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