Zobrazeno 1 - 10
of 20
pro vyhledávání: '"Detlew Labes"'
Publikováno v:
Journal of Pharmacy & Pharmaceutical Sciences, Vol 25 (2022)
Purpose: More than a decade ago the option to assess highly variable drugs / drug products by reference-scaled average bioequivalence was introduced in regulatory practice. Recommended approaches differ between jurisdictions and may lead to different
Externí odkaz:
https://doaj.org/article/d0fc7edd82164228b8e3a50f2fa7b350
Autor:
Stephan Lehr, Detlew Labes, Benjamin Lang, Hale Michael Don, Helmut Schütz, Thomas Jaki, Alexander Bauer, Richardus Vonk, Werner Engl, Martin J. Wolfsegger
Publikováno v:
Pharmaceutical Statistics. 20:272-281
For the clinical development of a new drug, the determination of dose-proportionality is an essential part of the pharmacokinetic evaluations, which may provide early indications of non-linear pharmacokinetics and may help to identify sub-populations
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbc0f969943e23e6911670bcd0a8b42e
https://doi.org/10.1002/pst.2074
https://doi.org/10.1002/pst.2074
Publikováno v:
UPCommons. Portal del coneixement obert de la UPC
Universitat Politècnica de Catalunya (UPC)
Universitat Politècnica de Catalunya (UPC)
This is the peer reviewed version of the following article: Molins, E. [et al.]. An iterative method to protect the type I error rate in bioequivalence studies under two-stage adaptive 2×2 crossover designs. "Biometrical journal", 2021, vol. 63, nú
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac8da20b842f5306f942f85cfb9f4be8
https://doi.org/10.1002/bimj.201900388
https://doi.org/10.1002/bimj.201900388
Autor:
Michael Tomashevskiy, Mario González-de la Parra, Helmut Schütz, Anastasia Shitova, Detlew Labes, Anders Fuglsang
Publikováno v:
The AAPS Journal. 22
In order to help companies qualify and validate the software used to evaluate bioequivalence trials in a replicate design intended for average bioequivalence with expanding limits, this work aims to define datasets with known results. This paper rele
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3666022e2e9c9ebc6c6a83c47409a5a1
https://doi.org/10.1208/s12248-020-0427-6
https://doi.org/10.1208/s12248-020-0427-6
Publikováno v:
Br J Clin Pharmacol
Aims Bioequivalence (BE) trials aim to demonstrate that the 90% confidence interval of the T/R-ratio of the pharmacokinetic metrics between two formulations (test [T] and reference [R]) of a drug is fully included in the acceptance interval [0.80, 1.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5e85ef9795ac9cca3eaaa529ca0d6a3c
https://europepmc.org/articles/PMC6783617/
https://europepmc.org/articles/PMC6783617/
Autor:
Helmut Schütz, Detlew Labes
Publikováno v:
Pharmaceutical Research. 33:2805-2814
To verify previously reported findings for the European Medicines Agency’s method for Average Bioequivalence with Expanding Limits (ABEL) for assessing highly variable drugs and to extend the assessment for other replicate designs in a wide range o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5ed7f36adaf8c20617f5a05209a7d229
https://doi.org/10.1007/s11095-016-2006-1
https://doi.org/10.1007/s11095-016-2006-1
Publikováno v:
The AAPS Journal. 17:400-404
In order to help companies qualify and validate the software used to evaluate bioequivalence trials with two parallel treatment groups, this work aims to define datasets with known results. This paper puts a total 11 datasets into the public domain a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::62204d9d04f343485071303af23be252
https://doi.org/10.1208/s12248-014-9704-6
https://doi.org/10.1208/s12248-014-9704-6
Publikováno v:
The AAPS Journal. 16:1292-1297
It is difficult to validate statistical software used to assess bioequivalence since very few datasets with known results are in the public domain, and the few that are published are of moderate size and balanced. The purpose of this paper is therefo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::29c9054abef8693fec926c49eb80ea73
https://doi.org/10.1208/s12248-014-9661-0
https://doi.org/10.1208/s12248-014-9661-0
Publikováno v:
Zeitschrift für Chemie. 13:182-183
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ca2b974ffa1d020cccfe050d3b60b082
https://doi.org/10.1002/zfch.19730130511
https://doi.org/10.1002/zfch.19730130511
Autor:
Detlew Labes, Hagen V
Publikováno v:
Europe PubMed Central
Using Hansch formalism, the suthors studied quantitatively the relationship between the structure and the inhibitory action of 3- and 4-substituted amidinophenyl derivatives on thrombin, plasmin and trypsin. It was found that the inhibitory action on
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::75f73d2dc08ba64dd2fe73cba38595bb
https://pubmed.ncbi.nlm.nih.gov/161621
https://pubmed.ncbi.nlm.nih.gov/161621