Zobrazeno 1 - 10
of 16
pro vyhledávání: '"Gian Christian Winkler"'
Publikováno v:
Regulatory Toxicology and Pharmacology. 122:104891
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 DC's occupational exposure limit (OEL) without toxicological d
Autor:
Ester Lovsin Barle, Gian Christian Winkler, Azeddine Elhajouji, Jana Nunic, Hans-Joerg Martus, Susanne Glowienke
Publikováno v:
Toxicological Sciences. 151:2-9
In the pharmaceutical industry, genotoxic drug substances are developed for life-threatening indications such as cancer. Healthy employees handle these substances during research, development, and manufacturing; therefore, safe handling of genotoxic
Autor:
Milica Glogovac, Ester Lovsin Barle, Gian Christian Winkler, Jean-Claude Bizec, Kamila Gromek
Publikováno v:
Pharmaceutical development and technology. 23(3)
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 in the manufacture of different medicinal products in
Autor:
Tiziana Catone, José Cotovio, Philippe Vanparys, Nancy B. Hopf, Dominique Schenk, Jennifer Molinari, Manfred Liebsch, Nathalie Alépée, Véronique Detappe, Luis Alfonso Arce, Patric Amcoff, Mirjam Fröhlicher, Jean Paul Derouette, Jack Clouzeau, Beat Johannes Brüschweiler, Robert Guest, Joachim Kreysa, Markus Hofmann, Valérie Zuang, Martina Hermann, Vanessa de Moura Sá-Rocha, Thomas Wallenhorst, Aurelia Oberli, Catherine Tomicic, Philippe Masson, Matthieu Ott, Federica d’Abrosca, Olivier Depallens, Cédric Delveaux, João Barroso, Oliver Engelking, Herman B. W. M. Koëter, Rostislav Cihak, Chantra Eskes, Bernadette Verdon, Gian Christian Winkler, Ronald Peter, Davide Facchini, Sebastian Hoffmann
Publikováno v:
Regulatory Toxicology and Pharmacology. 62:393-403
Validated in vitro methods for skin corrosion and irritation were adopted by the OECD and by the European Union during the last decade. In the EU, Switzerland and countries adopting the EU legislation, these assays may allow the full replacement of a
Autor:
Christopher Perino, Rudolf Bechter, Martin Kuster, Gian Christian Winkler, Alessandro Probst, Ester Lovsin Barle, Peter Ulrich, Silke Thielen
Publikováno v:
Regulatory Toxicology and Pharmacology. 70:122-124
During the chemical and pharmaceutical production of active pharmaceutical substances which are intended for immunosuppressive therapy, the employees may be exposed to these substances via inhalation. Immunosuppressants are linked to development of c
Autor:
Selene Araya, Ester Lovsin Barle, Gian Christian Winkler, Rudolf Bechter, Christopher Perino, Martin Kuster
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 72(3)
Workers in development and manufacturing of pharmaceuticals are at risk for occupational contact dermatitis (OCD) of irritative (ICD) or allergic (ACD) origin, due to contacts with reactive intermediates (IM) and drug substances (DS). We examined, if
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 70(1)
There is no nationally or internationally binding definition of the term "cytotoxic drug" although this term is used in a variety of regulations for pharmaceutical development and manufacturing of drugs as well as in regulations for protecting medica
Autor:
M. Milton, Maarten Prause, Gian Christian Winkler, Milica Glogovac, K. Gromek, E. Lovsin Barle, R. Newton, Jean-Claude Bizec
Publikováno v:
Toxicology Letters. 258:S219
Publikováno v:
Toxicology Letters. 238:S134
Publikováno v:
Toxicology Letters. 238:S56