Output

Here we make available publications and presentations generated by the IDEAS projects.

 

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Mielke, J., Schmidli, H., Jones, B. Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian-frequentist approach

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La Gamba, F., Corrao, G., Romio, S., Sturkenboom, M., Trifirò, G., Schink, T., de Ridder, M (2017) Combining evidence from multiple electronic health care databases: performances of one-stage and two-stage meta-analysis in matched case-control studies, Pharmacoepidemiology and Drug Safety

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Thomas, M., Bornkamnp, B, Seibold, H. (2018) Subgroup identification in dose-finding trials via model-based recursive partitioning, Statistics in Medicine (E-Publication in advance of print)

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Burmeister, G.E., Carroll K.J., Mielke J., Jones B., Benet L.Z (2017) Pharmacokinetic Behavior of Fluticasone Propionate and Salmeterol from Advair Diskus: The Consequences of Batch Variability, RDD Europe 2017. Volume 1, 2017: 25-34.

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Mielke J, Woehling H, Jones B. Longitudinal assessment of the impact of multiple switches between a biosimilar and its reference product on efficacy parameters. Pharmaceutical Statistics. 2018;1–17. https://doi.org/10.1002/pst.1849

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Mozgunov, P., Beccuti, M., Horvath, A., Jaki, T., Sirovich, R., & Bibbona, E. (2018) A review of the deterministic and diffusion approximations for stochastic chemical reaction networks. Reaction Kinetics, Mechanisms and Catalysis

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Vradi, E., Brannath, W., Jaki, T. & Vonk, R. Model selection based on combined penalties for biomarker identification

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Mielke, J., Jones, B., Jilma. & König, F. (2017) ‘Sample size for multiple hypothesis testing in biosimilar development’, Statistics in Biopharmaceutical Research

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Kelbert M, Mozgunov P. (2017) Generalization of Cramer-Rao and Bhattacharyya inequalities for the weighted covariance matrix. Mathematical Communications, 22:25-40.

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Bornkamp B, Thomas M (2016) Comparing Approaches to Treatment Effect Estimation for Subgroups in Clinical Trials. Statistics in Biopharmaceutical Research. Published online ahead of print.

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E Burmeister Getz, KJ Carroll, J Mielke, LZ Benet, B Jones (2017) Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial. Clinical Pharmacology & Therapeutics. 101:331-340.

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Mielke J, Jilma B, Koenig F, Jones B (2016) Clinical trials for authorized biosimilars in the European Union: a systematic review. British Journal of Clinical Pharmacology. 82:1444-1457