Ester Lovsin Barle
Overview
Explore the profile of Ester Lovsin Barle including associated specialties, affiliations and a list of published articles.
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20
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47
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Recent Articles
1.
Blum K, FitzGerald R, Wilks M, Barle E, Hopf N
J Appl Toxicol
. 2023 Feb;
43(8):1183-1200.
PMID: 36840679
N-Nitrosamines are potent carcinogens and considered non-threshold carcinogens in various regulatory domains. However, recent data indicate the existence of a threshold for genotoxicity, which can be adequately demonstrated. This aspect...
2.
Jolly R, Bandara S, Bercu J, Callis C, Dolan D, Graham J, et al.
Regul Toxicol Pharmacol
. 2022 Aug;
134:105242.
PMID: 35964842
Endogenous substances, such as fatty, amino, and nucleic acids, are often purposefully used in parenterally pharmaceuticals, but may be present as impurities. Currently, no consensus guidance exists on setting impurity...
3.
Wiesner L, Araya S, Barle E
J Appl Toxicol
. 2022 Mar;
42(9):1443-1457.
PMID: 35315528
Contract Development and Manufacturing Organizations (CDMOs) that manufacture large, diverse portfolio of chemical and pharmaceutical substances require pragmatic risk-based decisions with respect to the safe carry-over between different chemical entities,...
4.
Glogovac M, Paulson C, Lambert A, Winkler G, Barle E
Regul Toxicol Pharmacol
. 2021 Feb;
122:104891.
PMID: 33587935
In the early stages of drug research and development, there are only a few or no toxicological data available for newly synthesized small molecule drug candidates (DC). Calculation of the...
5.
Deriving harmonised permitted daily exposures (PDEs) for paracetamol (acetaminophen) CAS #: 103-90-2
Gromek K, Hawkins W, Bernier T, Sehner C, Zeller E, Schwind M, et al.
Regul Toxicol Pharmacol
. 2020 Jun;
115:104692.
PMID: 32522580
In the pharmaceutical industry, cleaning criteria are required for multipurpose manufacturing facilities. These Health Based Exposure Limits (HBELs), also called permitted daily exposures (PDEs) values, are derived from toxicological and...
6.
Sehner C, Schwind M, Tuschl G, Barle E
Pharm Dev Technol
. 2019 Mar;
24(7):803-811.
PMID: 30865481
For the handling of active pharmaceutical ingredients (APIs) and production of medicinal products in shared facilities, the European Medicines Agency (EMA) has introduced the determination of permitted daily exposure (PDE)...
7.
Barle E, Pfister T, Fux C, Rothlisberger D, Jere D, Mahler H
Regul Toxicol Pharmacol
. 2018 Oct;
101:29-34.
PMID: 30367903
A toxicological evaluation to determine the product specific permitted daily exposure (PDE) value is an accepted method to determine a safe limit for the carry-over of product residues in multipurpose...
8.
Jandard C, Hemming H, Prause M, Sehner C, Schwind M, Abromovitz M, et al.
Regul Toxicol Pharmacol
. 2017 Dec;
95:434-441.
PMID: 29288720
Within the context of Occupational Hygiene (OH), surface sampling has been employed as a method to assess surface levels of Active Pharmaceutical Ingredients (APIs). There are potentially a number of...
9.
Wiesner L, Prause M, Barle E
Pharm Dev Technol
. 2017 May;
23(3):261-264.
PMID: 28535123
Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities...
10.
Barle E, Bizec J, Glogovac M, Gromek K, Winkler G
Pharm Dev Technol
. 2017 Apr;
23(3):225-230.
PMID: 28361586
Limits for the carry-over of product residues should be based on toxicological evaluation such as described in the "Guideline on setting health based exposure limits for use in risk identification...