Model Description Language (MDL): A Standard for Modeling and Simulation

Autor: Smith, MK, Moodie, SL, Bizzotto, R, E, Blaudez., Borella, E, Carrara, L, Chan, P, Chenel, M, Comets, E, Gieschke, R, Harling, K, Harnisch, L, Hartung, N, Hooker, AC, Karlsson, MO, Kaye, R, Kloft, C, Kokash, N, Lavielle, M, Lestini, G, Magni, P, Mari, A, Mentré, F, Muselle, C, Nordgren, R, Nyberg, HB, Parra-Guillén, ZP, Pasotti, L, Rode-Kristensen, N, Sardu, ML, Smith, GR, Swat, MJ, Terranova, N, Yngman, G, Yvon, F, Holford, N, consortium, DDMoRe

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology

Recent work on Model Informed Drug Discovery and Development (MID3) has noted the need for clarity in model description used in quantitative disciplines such as pharmacology and statistics. 1-3 Currently, models are encoded in a variety of computer l

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::c1e760f1b513fd790d02856dd2db557e
https://pubmed.ncbi.nlm.nih.gov/28643440

Trial treatment length optimization with an emphasis on disease progression studies.

Autor: Hennig S, Nyberg J, Hooker AC, Karlsson MO

Publikováno v: Journal of Clinical Pharmacology; Mar2009, Vol. 49 Issue 3, p323-335, 13p

Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points.

Autor: Chen X; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Nyberg HB; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Donnelly M; Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Zhao L; Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Fang L; Division of Quantitative Methods and Modeling, Office of Research Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Karlsson MO; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Hooker AC; Department of Pharmacy, Uppsala University, Uppsala, Sweden.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Oct; Vol. 13 (10), pp. 1734-1747. Date of Electronic Publication: 2024 Aug 23.

Longitudinal Analysis of Natural History Progression of Rare and Ultra-Rare Cerebellar Ataxias Using Item Response Theory.

Autor: Hamdan A; Pharmacometrics Research Group, Department of Pharmacy, Uppsala University, Uppsala, Sweden., Hendrickx N; Université Paris Cité, IAME, Inserm, Paris, France., Hooker AC; Pharmacometrics Research Group, Department of Pharmacy, Uppsala University, Uppsala, Sweden., Chen X; Pharmacometrics Research Group, Department of Pharmacy, Uppsala University, Uppsala, Sweden., Comets E; Université Paris Cité, IAME, Inserm, Paris, France.; Univ Rennes, Inserm, EHESP, Irset - UMR_S 1085, Rennes, France., Traschütz A; Department of Neurodegenerative Diseases, Center for Neurology and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.; German Center for Neurodegenerative Diseases (DZNE) Tübingen, Tübingen, Germany., Schüle R; Department of Neurodegenerative Diseases, Center for Neurology and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.; Division of Neurodegenerative Diseases, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany., Mentré F; Université Paris Cité, IAME, Inserm, Paris, France., Synofzik M; Department of Neurodegenerative Diseases, Center for Neurology and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.; German Center for Neurodegenerative Diseases (DZNE) Tübingen, Tübingen, Germany., Karlsson MO; Pharmacometrics Research Group, Department of Pharmacy, Uppsala University, Uppsala, Sweden.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Dec; Vol. 116 (6), pp. 1593-1605. Date of Electronic Publication: 2024 Oct 15.

Methods for non-proportional hazards in clinical trials: A systematic review.

Autor: Bardo M; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; Maximilian Bardo and Cynthia Huber contributed equally to this study., Huber C; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; Maximilian Bardo and Cynthia Huber contributed equally to this study., Benda N; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Brugger J; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Fellinger T; Agentur für Gesundheit und Ernährungssicherheit (AGES), Vienna, Austria., Galaune V; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Heinz J; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany., Heinzl H; Center for Medical Data Science, Section of Clinical Biometrics, Medical University of Vienna, Vienna, Austria., Hooker AC; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Klinglmüller F; Agentur für Gesundheit und Ernährungssicherheit (AGES), Vienna, Austria., König F; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Mathes T; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany., Mittlböck M; Center for Medical Data Science, Section of Clinical Biometrics, Medical University of Vienna, Vienna, Austria., Posch M; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Ristl R; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Friede T; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.

Publikováno v: Statistical methods in medical research [Stat Methods Med Res] 2024 Jun; Vol. 33 (6), pp. 1069-1092. Date of Electronic Publication: 2024 Apr 09.