Zobrazeno 1 - 10 of 59 pro vyhledávání: '"Lovsin-Barle E"'
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
Identifying nonhazardous substances in pharmaceutical manufacturing and setting default health-based exposure limits (HBELs).
Autor: Wiesner L; Lonza, Basel, Switzerland., Araya S; Lonza, Basel, Switzerland., Lovsin Barle E; Takeda Pharmaceuticals, Glattpark, Switzerland.
Publikováno v: Journal of applied toxicology : JAT [J Appl Toxicol] 2022 Sep; Vol. 42 (9), pp. 1443-1457. Date of Electronic Publication: 2022 Apr 04.
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3
Akademický článek
Disease area and mode of action as criteria to assign a default occupational exposure limit.
Autor: Glogovac M; Novartis Pharma AG, Novartis Business Services, Postfach, CH-4002, Basel, Switzerland. Electronic address: milica.glogovac@novartis.com., Paulson C; Novartis Pharma AG, Novartis Business Services, Postfach, CH-4002, Basel, Switzerland. Electronic address: caylee.paulson@novartis.com., Lambert A; Novartis Institutes for BioMedical Research, Cambridge, USA; Roche Innovation Center Zurich, Wagistrasse 10, CH-8952, Schlieren, Switzerland. Electronic address: amy_letitia.lambert@roche.com., Winkler GC; Novartis Pharma AG NIBR, Postfach, CH-4002, Basel, Switzerland; Preclinical Safety Consultant, In den Reben 229, CH-5063, Oberhof, Switzerland. Electronic address: winkgu@vtxnet.ch., Lovsin Barle E; Novartis Pharma AG, Novartis Business Services, Postfach, CH-4002, Basel, Switzerland; Takeda Pharmaceutical Company Limited, Thurgauerstrasse 130, CH-8152, Glattpark (Opfikon), Switzerland. Electronic address: ester.lovsin-barle@takeda.com.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Jun; Vol. 122, pp. 104891. Date of Electronic Publication: 2021 Feb 12.
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4
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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5
Akademický článek
An Investigation on the Relationship between Dust Emission and Air Flow as Well as Particle Size with a Novel Containment Two-Chamber Setup.
Autor: Wirth, Steffen1 (AUTHOR) steffen.wirth@uni-hamburg.de, Schöler, Martin2 (AUTHOR) mschoeler@fette-compacting.com, Brügmann, Jonas2 (AUTHOR), Leopold, Claudia S.1 (AUTHOR) claudia.leopold@uni-hamburg.de
Publikováno v: Pharmaceutics. Aug2024, Vol. 16 Issue 8, p1088. 17p.
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6
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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7
Akademický článek
Use of the permitted daily exposure (PDE) concept for contaminants of intravitreal (IVT) drugs in multipurpose manufacturing facilities.
Autor: Lovsin Barle E; Lonza AG, CH-4002, Basel, Switzerland. Electronic address: ester.lovsinbarle@lonza.com., Pfister T; Hoffman la Roche GmbH, CH-4002, Basel, Switzerland., Fux C; Lonza AG, CH-4002, Basel, Switzerland., Röthlisberger D; Lonza AG, CH-4002, Basel, Switzerland., Jere D; Lonza AG, CH-4002, Basel, Switzerland., Mahler HC; Lonza AG, CH-4002, Basel, Switzerland.
Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2019 Feb; Vol. 101, pp. 29-34. Date of Electronic Publication: 2018 Oct 24.
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8
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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9
Akademický článek
Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE).
Autor: Wiesner L; a Novartis Pharma AG, Postfach , Basel , Switzerland., Prause M; a Novartis Pharma AG, Postfach , Basel , Switzerland., Lovsin Barle E; a Novartis Pharma AG, Postfach , Basel , Switzerland.
Publikováno v: Pharmaceutical development and technology [Pharm Dev Technol] 2018 Mar; Vol. 23 (3), pp. 261-264. Date of Electronic Publication: 2017 Jun 07.
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10
Akademický článek
Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities.
Autor: Lovsin Barle E; a Novartis Pharma AG, Postfach , Basel , Switzerland., Bizec JC; b Novartis Pharma AG NIBR, Postfach , Basel , Switzerland., Glogovac M; a Novartis Pharma AG, Postfach , Basel , Switzerland., Gromek K; a Novartis Pharma AG, Postfach , Basel , Switzerland., Winkler GC; b Novartis Pharma AG NIBR, Postfach , Basel , Switzerland.
Publikováno v: Pharmaceutical development and technology [Pharm Dev Technol] 2018 Mar; Vol. 23 (3), pp. 225-230. Date of Electronic Publication: 2017 Apr 12.
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