Zobrazeno 1 - 10 of 95 pro vyhledávání: '"Sehner C"'
1
Akademický článek
Comparison of permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs) - Evidence of a robust approach.
Autor: Sehner C; Boehringer Ingelheim Pharma GmbH & Co. KG, 88397, Biberach, Germany. Electronic address: claudia.sehner@boehringer-ingelheim.com., Bernier T; Abbott Laboratories GmbH, 31535, Neustadt Am Rübenberge, Germany., Blum K; GlaxoSmithKline, Prinzregentenplatz 9, 81675, Munich, Germany., Clemann N; F. Hoffmann-La Roche Ltd, 4070, Basel, Switzerland., Glogovac M; Novartis International AG, Lichtstr. 35, Basel, Switzerland., Hawkins WA; SafeBridge Europe Ltd., 33 St Andrews Street South, Bury St Edmunds, IP33 3PH, Suffolk, United Kingdom., Kohan M; SafeBridge Europe Ltd., 33 St Andrews Street South, Bury St Edmunds, IP33 3PH, Suffolk, United Kingdom., Linker F; Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany., Lovsin-Barle E; Takeda Pharmaceuticals International AG, Glattpark-Opfikon, Switzerland., Osadolor O; AstraZeneca, Francis Crick Avenue, Cambridge, United Kingdom., Pfister T; F. Hoffmann-La Roche Ltd, 4070, Basel, Switzerland., Schulze E; Merck Healthcare KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany., Schwind M; Sanofi-Aventis Deutschland GmbH, 65926, Frankfurt, Germany., Tuschl G; Merck Healthcare KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany., Wiesner L; Takeda Pharmaceuticals International AG, Glattpark-Opfikon, Switzerland.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Jun; Vol. 150, pp. 105649. Date of Electronic Publication: 2024 May 21.
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2
Akademický článek
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3
Akademický článek
Deriving harmonised permitted daily exposures (PDEs) for paracetamol (acetaminophen) CAS #: 103-90-2.
Autor: Gromek K; GlaxoSmithKline, United Kingdom. Electronic address: kamila.x.gromek@gsk.com., Hawkins W; GlaxoSmithKline, United Kingdom. Electronic address: william.a.hawkins@gsk.com., Bernier T; Abbott, United States. Electronic address: tanja.bernier@abbott.com., Sehner C; Boehringer Ingelheim, Germany. Electronic address: claudia.sehner@boehringer-ingelheim.com., Zeller E; Boehringer Ingelheim, Germany. Electronic address: eva_2.zeller@boehringer-ingelheim.com., Schwind M; Sanofi, France. Electronic address: markus.Schwind@sanofi.com., Pfister T; Roche, Switzerland. Electronic address: thomas.pfister.tp1@roche.com., Kohan M; Astra Zeneca, United Kingdom. Electronic address: martin.kohan@astrazeneca.com., Osadolor O; Novartis, Switzerland. Electronic address: osahon.osadolor@novartis.com., Glogovac M; Novartis, Switzerland. Electronic address: milica.glogovac@novartis.com., Tuschl G; Merck Healthcare KGaA, Germany. Electronic address: gregor.tuschl@merckgroup.com., Dolan DG; Amgen Inc., United States. Electronic address: ddolan@amgen.com., Lovsin Barle E; Takeda, Switzerland. Electronic address: ester.lovsin-barle@takeda.com.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2020 Aug; Vol. 115, pp. 104692. Date of Electronic Publication: 2020 Jun 06.
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4
Akademický článek
What to consider for a good quality PDE document?
Autor: Sehner C; a Nonclinical Drug Safety , Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riss , Germany., Schwind M; b HSE Germany, Sanofi-Aventis Deutschland GmbH , Frankfurt am Main , Germany., Tuschl G; c Global Chemical and Preclinical Safety , Merck KGaA , Darmstadt , Germany., Lovsin Barle E; d Department of Regulatory Affairs , Lonza AG , Basel , Switzerland.
Publikováno v: Pharmaceutical development and technology [Pharm Dev Technol] 2019 Sep; Vol. 24 (7), pp. 803-811. Date of Electronic Publication: 2019 May 06.
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5
Akademický článek
Applicability of surface sampling and calculation of surface limits for pharmaceutical drug substances for occupational health purposes.
Autor: Jandard C; Servier Group, Gidy, France. Electronic address: camille.jandard@servier.com., Hemming H; Astra Zeneca AB, Södertälje, Sweden., Prause M; Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland., Sehner C; Boehringer Ingelheim Pharma GmbH & Co. KG, Germany., Schwind M; Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany., Abromovitz M; Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland., Lovsin Barle E; Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2018 Jun; Vol. 95, pp. 434-441. Date of Electronic Publication: 2017 Dec 27.
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6
Akademický článek
A harmonization effort for acceptable daily exposure derivation - Considerations for application of adjustment factors.
Autor: Sussman RG; SafeBridge Consultants, Inc., USA. Electronic address: robert.sussman@safebridge.com., Naumann BD; Merck & Co., Inc., USA., Pfister T; F. Hoffmann-La Roche Ltd, USA., Sehner C; Boehringer Ingelheim Pharma GmbH & Co. KG, USA., Seaman C; GlaxoSmithKline, USA., Weideman PA; Genentech, Inc., USA.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2016 Aug; Vol. 79 Suppl 1, pp. S57-66. Date of Electronic Publication: 2016 May 21.
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7
Akademický článek
Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs).
Autor: Bercu JP; Gilead Sciences, Inc., United States. Electronic address: joel.bercu@gilead.com., Morinello EJ; Genentech, Inc., United States., Sehner C; Boehringer Ingelheim Pharma GmbH & Co. KG, Germany., Shipp BK; Pfizer, Inc., United States., Weideman PA; Genentech, Inc., United States.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2016 Aug; Vol. 79 Suppl 1, pp. S48-56. Date of Electronic Publication: 2016 May 24.
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8
Akademický článek
Using default methodologies to derive an acceptable daily exposure (ADE).
Autor: Faria EC; Janssen Pharmaceutical Company, an Affiliate of Johnson & Johnson, United States. Electronic address: efaria1@its.jnj.com., Bercu JP; Gilead Sciences, Inc., United States., Dolan DG; Amgen Inc., United States., Morinello EJ; Genentech, Inc., United States., Pecquet AM; University of Cincinnati, United States., Seaman C; GlaxoSmithKline, United Kingdom., Sehner C; Boehringer Ingelheim Pharma GmbH & Co. KG, Germany., Weideman PA; Genentech, Inc., United States.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2016 Aug; Vol. 79 Suppl 1, pp. S28-38. Date of Electronic Publication: 2016 May 24.
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10
Akademický článek
An in vitro embryotoxicity assay based on the disturbance of the differentiation of murine embryonic stem cells into endothelial cells. II. Testing of compounds.
Autor: Festag M; Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany. matthias.festag@roche.com, Viertel B, Steinberg P, Sehner C
Publikováno v: Toxicology in vitro : an international journal published in association with BIBRA [Toxicol In Vitro] 2007 Dec; Vol. 21 (8), pp. 1631-40. Date of Electronic Publication: 2007 Jul 18.
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