Author

Johanna Mielke

Observed names: J Mielke, J. Mielke, Janka Mielke, Mielke, Johanna

Institution: Bayer (Germany)

Observed institutions: Novartis (Switzerland), TU Dortmund University, Janssen (Germany), Bayer (Germany)

ORCID: 0000-0002-4239-5499

Observed ORCID: 0000-0002-4239-5499

OpenAlex ID: A5082020092

Genetic studies of paired metabolomes reveal enzymatic and transport processes at the interface of plasma and urine

2023 · Pascal Schlosser, Nora Scherer, et al. · Nature Genetics · 86

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Cohort design and natural language processing to reduce bias in electronic health records research

2022 · Shaan Khurshid, Christopher Reeder, et al. · npj Digital Medicine · 81

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Machine learning for subtype definition and risk prediction in heart failure, acute coronary syndromes and atrial fibrillation: systematic review of validity and clinical utility

2021 · Amitava Banerjee, Suliang Chen, et al. · BMC Medicine · 78

Environmental and genetic predictors of human cardiovascular ageing

2023 · Mit Shah, Marco H. de A. Inácio, et al. · Nature Communications · 66

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Leveraging Human Genetics to Estimate Clinical Risk Reductions Achievable by Inhibiting Factor XI

2019 · Benjamin Georgi, Johanna Mielke, et al. · Stroke · 62

Genetic and environmental determinants of diastolic heart function

2022 · Marjola Thanaj, Johanna Mielke, et al. · Nature Cardiovascular Research · 59

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Rare genetic variants affecting urine metabolite levels link population variation to inborn errors of metabolism

2021 · Yurong Cheng, Pascal Schlosser, et al. · Nature Communications · 37

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An update on the clinical evidence that supports biosimilar approvals in Europe

2018 · Johanna Mielke, Bernd Jilma, et al. · British Journal of Clinical Pharmacology · 25

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Clinical trials for authorized biosimilars in the European Union: a systematic review

2016 · Johanna Mielke, Bernd Jilma, et al. · British Journal of Clinical Pharmacology · 23

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Between‐Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial

2016 · E Burmeister Getz, KJ Carroll, et al. · Clinical Pharmacology & Therapeutics · 21

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A Longitudinal Item Response Theory Model to Characterize Cognition Over Time in Elderly Subjects

2017 · Marc Vandemeulebroecke, Björn Bornkamp, et al. · CPT Pharmacometrics & Systems Pharmacology · 19

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An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations

2023 · Christos Chouaid, Lise Bosquet, et al. · Advances in Therapy · 18

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Deep learning on resting electrocardiogram to identify impaired heart rate recovery

2022 · Nathaniel Diamant, Paolo Di Achille, et al. · Cardiovascular Digital Health Journal · 13

Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach

2018 · Johanna Mielke, Heinz Schmidli, et al. · Biometrical Journal · 13

Self-Reported Medication Use and Urinary Drug Metabolites in the German Chronic Kidney Disease (GCKD) Study

2021 · Fruzsina Kotsis, Ulla T. Schultheiss, et al. · Journal of the American Society of Nephrology · 12

The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal

2018 · Johanna Mielke, Franz Innerbichler, et al. · The AAPS Journal · 12

Sample Size for Multiple Hypothesis Testing in Biosimilar Development

2017 · Johanna Mielke, Byron Jones, et al. · Statistics in Biopharmaceutical Research · 9

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Blood pressure control and cardiovascular risk in hypertensive patients with type 2 diabetes: The German T2Target registry

2017 · Thomas Mengden, Uwe Ligges, et al. · Journal of Clinical Hypertension · 8

Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters

2018 · Johanna Mielke, Heike Woehling, et al. · Pharmaceutical Statistics · 6

Prevalence, phenotypic characteristics and prognostic role of apparent treatment resistant hypertension in the German Chronic Kidney Disease (GCKD) study

2022 · Johanna Mielke, Holger Trucks-Jansen, et al. · Journal of Human Hypertension · 5

Batch Selection via In Vitro/In Vivo Correlation in Pharmacokinetic Bioequivalence Testing

2021 · Elise Burmeister Getz, Kevin J. Carroll, et al. · AAPS PharmSciTech · 5

Sharing Medical Big Data While Preserving Patient Confidentiality in Innovative Medicines Initiative: A Summary and Case Report from BigData@Heart

2023 · Megan Schröder, Sam H.A. Muller, et al. · Big Data · 4

Author Correction: Rare genetic variants affecting urine metabolite levels link population variation to inborn errors of metabolism

2021 · Yurong Cheng, Pascal Schlosser, et al. · Nature Communications · 4

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Testing Procedures for Claiming Success on at Least k Out of m Hypotheses with an Application to Biosimilar Development

2020 · Johanna Mielke, Byron Jones, et al. · Statistics in Biopharmaceutical Research · 3

Quantifying risk modifiers of hereditary hemochromatosis using genomic and electronic health record data