Aarhus Universitets segl

English

Du er her: AU » Om AU » Organisation » The Application of Human Phase 0 Microdosing Trials

Om AU

The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Standard

The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives. / Svendsen, Pernille; El-Galaly, Tarec C; Dybkær, Karen et al.
I: Leukemia and Lymphoma, Bind 57, Nr. 6, 01.10.2015, s. 1281-1290.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

Harvard

Svendsen, P, El-Galaly, TC, Dybkær, K, Bøgsted, M, Laursen, MB, Schmitz, A, Jensen, P & Johnsen, HE 2015, 'The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives', Leukemia and Lymphoma, bind 57, nr. 6, s. 1281-1290. https://doi.org/10.3109/10428194.2015.1101097

APA

Svendsen, P., El-Galaly, T. C., Dybkær, K., Bøgsted, M., Laursen, M. B., Schmitz, A., Jensen, P., & Johnsen, H. E. (2015). The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives. Leukemia and Lymphoma, 57(6), 1281-1290. https://doi.org/10.3109/10428194.2015.1101097

CBE

Svendsen P, El-Galaly TC, Dybkær K, Bøgsted M, Laursen MB, Schmitz A, Jensen P, Johnsen HE. 2015. The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives. Leukemia and Lymphoma. 57(6):1281-1290. https://doi.org/10.3109/10428194.2015.1101097

MLA

Svendsen, Pernille et al. "The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives". Leukemia and Lymphoma. 2015, 57(6). 1281-1290. https://doi.org/10.3109/10428194.2015.1101097

Vancouver

Svendsen P, El-Galaly TC, Dybkær K, Bøgsted M, Laursen MB, Schmitz A et al. The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives. Leukemia and Lymphoma. 2015 okt. 1;57(6):1281-1290. doi: 10.3109/10428194.2015.1101097

Author

Svendsen, Pernille ; El-Galaly, Tarec C ; Dybkær, Karen et al. / The Application of Human Phase 0 Microdosing Trials : a Systematic Review and Perspectives. I: Leukemia and Lymphoma. 2015 ; Bind 57, Nr. 6. s. 1281-1290.

Bibtex

@article{485bfb688fdf42d0acaca4e9f4cc7442,
title = "The Application of Human Phase 0 Microdosing Trials: a Systematic Review and Perspectives",
abstract = "A decreasing number of new therapeutic drugs reaching the clinic has led to the publication of regulatory guidelines on human microdosing trials by the European Medicines Agency in 2004 and the U.S. Food and Drug Administration in 2006. Microdosing trials are defined by the administration of 1/100(th) of the therapeutic dose and designed to investigate basic drug properties. This review investigates the current application of phase 0 trials in medical research. Thirty-three studies found in PubMed and EMBASE were systematically reviewed for aim and analytical method. Pharmacokinetic studies have been a major focus of phase 0 trials, but drug distribution, drug-drug interactions, imaging, and pharmacogenomics have also been investigated. Common analytical methods were tandem mass liquid chromatography, accelerator mass spectrometry, and positron emission tomography. New ongoing trials are investigating the pharmacodynamics and chemoresistance of marketed drugs, suggesting that the application of phase 0 trials is still evolving.",
author = "Pernille Svendsen and El-Galaly, {Tarec C} and Karen Dybk{\ae}r and Martin B{\o}gsted and Laursen, {Maria B} and Alexander Schmitz and Paw Jensen and Johnsen, {Hans E}",
year = "2015",
month = oct,
day = "1",
doi = "10.3109/10428194.2015.1101097",
language = "English",
volume = "57",
pages = "1281--1290",
journal = "Leukemia and Lymphoma",
issn = "1042-8194",
publisher = "Taylor & Francis ",
number = "6",

}

RIS

TY - JOUR

T1 - The Application of Human Phase 0 Microdosing Trials

T2 - a Systematic Review and Perspectives

AU - Svendsen, Pernille

AU - El-Galaly, Tarec C

AU - Dybkær, Karen

AU - Bøgsted, Martin

AU - Laursen, Maria B

AU - Schmitz, Alexander

AU - Jensen, Paw

AU - Johnsen, Hans E

PY - 2015/10/1

Y1 - 2015/10/1

N2 - A decreasing number of new therapeutic drugs reaching the clinic has led to the publication of regulatory guidelines on human microdosing trials by the European Medicines Agency in 2004 and the U.S. Food and Drug Administration in 2006. Microdosing trials are defined by the administration of 1/100(th) of the therapeutic dose and designed to investigate basic drug properties. This review investigates the current application of phase 0 trials in medical research. Thirty-three studies found in PubMed and EMBASE were systematically reviewed for aim and analytical method. Pharmacokinetic studies have been a major focus of phase 0 trials, but drug distribution, drug-drug interactions, imaging, and pharmacogenomics have also been investigated. Common analytical methods were tandem mass liquid chromatography, accelerator mass spectrometry, and positron emission tomography. New ongoing trials are investigating the pharmacodynamics and chemoresistance of marketed drugs, suggesting that the application of phase 0 trials is still evolving.

AB - A decreasing number of new therapeutic drugs reaching the clinic has led to the publication of regulatory guidelines on human microdosing trials by the European Medicines Agency in 2004 and the U.S. Food and Drug Administration in 2006. Microdosing trials are defined by the administration of 1/100(th) of the therapeutic dose and designed to investigate basic drug properties. This review investigates the current application of phase 0 trials in medical research. Thirty-three studies found in PubMed and EMBASE were systematically reviewed for aim and analytical method. Pharmacokinetic studies have been a major focus of phase 0 trials, but drug distribution, drug-drug interactions, imaging, and pharmacogenomics have also been investigated. Common analytical methods were tandem mass liquid chromatography, accelerator mass spectrometry, and positron emission tomography. New ongoing trials are investigating the pharmacodynamics and chemoresistance of marketed drugs, suggesting that the application of phase 0 trials is still evolving.

U2 - 10.3109/10428194.2015.1101097

DO - 10.3109/10428194.2015.1101097

M3 - Journal article

C2 - 26428262

VL - 57

SP - 1281

EP - 1290

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

SN - 1042-8194

IS - 6

ER -