Search Results - "Barle, Ester Lovsin"

Identifying nonhazardous substances in pharmaceutical manufacturing and setting default health‐based exposure limits (HBELs) by Wiesner, Lisa, Araya, Selene, Lovsin Barle, Ester

“…Contract Development and Manufacturing Organizations (CDMOs) that manufacture large, diverse portfolio of chemical and pharmaceutical substances require…”
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The value of acute toxicity testing of pharmaceuticals for estimation of human response by Lovšin Barle, Ester, Looser, Roland, Černe, Manica, Bechter, Rudolf

“…► Acute oral LD50 of rats have poor correlation with the METD, and cannot be used as a classification criteria. ► Substances with very low therapeutic doses…”
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Disease area and mode of action as criteria to assign a default occupational exposure limit by Glogovac, Milica, Paulson, Caylee, Lambert, Amy, Winkler, Gian Christian, Lovsin Barle, Ester

“…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…”
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Use of the benchmark‐dose (BMD) approach to derive occupational exposure limits (OELs) for genotoxic carcinogens: N‐nitrosamines by Blum, Kamila, FitzGerald, Rex, Wilks, Martin F., Barle, Ester Lovsin, Hopf, Nancy B.

“…N‐Nitrosamines are potent carcinogens and considered non‐threshold carcinogens in various regulatory domains. However, recent data indicate the existence of a…”
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Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE) by Wiesner, Lisa, Prause, Maarten, Lovsin Barle, Ester

“…Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily…”
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What to consider for a good quality PDE document? by Sehner, Claudia, Schwind, Markus, Tuschl, Gregor, Lovsin Barle, Ester

“…For the handling of active pharmaceutical ingredients (APIs) and production of medicinal products in shared facilities, the European Medicines Agency (EMA) has…”
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Deriving harmonised permitted daily exposures (PDEs) for paracetamol (acetaminophen) CAS #: 103-90-2 by Gromek, Kamila, Hawkins, William, Bernier, Tanja, Sehner, Claudia, Zeller, Eva, Schwind, Markus, Pfister, Thomas, Kohan, Martin, Osadolor, Osahon, Glogovac, Milica, Tuschl, Gregor, Dolan, David G., Lovsin Barle, Ester

“…In the pharmaceutical industry, cleaning criteria are required for multipurpose manufacturing facilities. These Health Based Exposure Limits (HBELs), also…”
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Applicability of surface sampling and calculation of surface limits for pharmaceutical drug substances for occupational health purposes by Jandard, Camille, Hemming, Helena, Prause, Maarten, Sehner, Claudia, Schwind, Markus, Abromovitz, Marc, Lovsin Barle, Ester

“…Within the context of Occupational Hygiene (OH), surface sampling has been employed as a method to assess surface levels of Active Pharmaceutical Ingredients…”
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Use of the permitted daily exposure (PDE) concept for contaminants of intravitreal (IVT) drugs in multipurpose manufacturing facilities by Lovsin Barle, Ester, Pfister, Thomas, Fux, Cornelia, Röthlisberger, Dieter, Jere, Dhananjay, Mahler, Hanns-Christian

“…A toxicological evaluation to determine the product specific permitted daily exposure (PDE) value is an accepted method to determine a safe limit for the…”
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Setting Occupational Exposure Limits for Genotoxic Substances in the Pharmaceutical Industry by Lovsin Barle, Ester, Winkler, Gian Christian, Glowienke, Susanne, Elhajouji, Azeddine, Nunic, Jana, Martus, Hans-Joerg

“…In the pharmaceutical industry, genotoxic drug substances are developed for life-threatening indications such as cancer. Healthy employees handle these…”
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Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities by Lovsin Barle, Ester, Bizec, Jean-Claude, Glogovac, Milica, Gromek, Kamila, Winkler, Gian Christian

“…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…”
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Classification of dermal sensitizers in pharmaceutical manufacturing by Winkler, Gian C., Perino, Christopher, Araya, Selene H., Bechter, Rudolf, Kuster, Martin, Lovsin Barle, Ester

“…•We reviewed the status of alternative methods for skin sensitization hazard.•For some of the alternative in vitro tests OECD test protocols are…”
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Reduced intravenous toxicity of amiodarone nanosuspension in mice and rats by Barle, Ester Lovšin, erne, Manica, Peternel, Luka, Homar, Miha

“…The toxicity of amiodarone Lek formulation (test formulation) was investigated after a single intravenous (i.v.) administration to mice and rats. When compared…”
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Group assessment of drug substances with same mechanism of action and safety profile for purpose of setting occupational exposure limits by Prause, Maarten, Glogovac, Milica, Barle, Ester Lovsin

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Comparison of Permitted Daily Exposure (PDE) Values for Active Pharmaceutical Ingredients (APIs) - Evidence of Robust Approach by Sehner, Claudia, Bernier, Tanja, Blum, Kamila, Clemann, Nicole, Glogovac, Milica, Hawkins, William A., Kohan, Martin, Linker, Fenneke, Lovsin-Barle, Ester, Osadolor, Osahon, Pfister, Thomas, Schulze, Elisa, Schwind, Markus, Tuschl, Gregor, Wiesner, Lisa

“…Permitted Daily Exposure Limits (PDEs) are set for Active Pharmaceutical Ingredients (APIs) to control cross-contamination when manufacturing medicinal…”
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Functional differentiation of cytotoxic cancer drugs and targeted cancer therapeutics by Winkler, Gian C., Barle, Ester Lovsin, Galati, Giuseppe, Kluwe, William M.

“…•“Cytotoxic drug” term is frequently used as a synonym for any antineoplastic drug.•This publication provides a functional definition for cytotoxic cancer…”
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The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future by Sargent, Edward V., Flueckiger, Andreas, Barle, Ester Lovsin, Luo, Wendy, Molnar, Lance R., Sandhu, Reena, Weideman, Patricia A.

“…Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact both product safety and quality. This issue has been recognized by…”
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Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure by Araya, Selene, Lovsin-Barle, Ester, Glowienke, Susanne

“…Pharmaceutical intermediates (IM) are used in the synthesis of active pharmaceutical ingredients. They are not intended for human administration, yet employees…”
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Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids by Jolly, Robert A., Bandara, Suren, Bercu, Joel, Callis, Courtney M., Dolan, David G., Graham, Jessica, HaMai, Diem, Barle, Ester Lovsin, Maier, Andrew, Masuda-Herrera, Melisa, Moudgal, Chandrika, Parker, Jillian A., Reichard, John, Sandhu, Reena, Fung, Ernest S.

“…Endogenous substances, such as fatty, amino, and nucleic acids, are often purposefully used in parenterally pharmaceuticals, but may be present as impurities…”
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Classified carcinogens: What is their potential risk for pharmaceutical manufacturing employees? by Araya, Selene, Winkler, Gian Christian, Froehlicher, Mirjam, Barle, Ester Lovsin

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