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Pharmaceutical Development and Technology Volume 23, 2018 - Issue 3: Issue Theme: Ocular, otic, nasal, rectal and vaginal formulation innovations and regulatory considerations
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Otic

Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE)

Lisa WiesnerNovartis Pharma AG, Postfach, Basel, Switzerland
,
Maarten PrauseNovartis Pharma AG, Postfach, Basel, Switzerland
&
Ester Lovsin BarleNovartis Pharma AG, Postfach, Basel, SwitzerlandCorrespondence[email protected]
Pages 261-264 | Received 30 Jan 2017, Accepted 22 May 2017, Published online: 07 Jun 2017

Citations (7)

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Claudia Sehner, Markus Schwind, Gregor Tuschl & Ester Lovsin Barle. (2019) What to consider for a good quality PDE document?. Pharmaceutical Development and Technology 24:7, pages 803-811.
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Articles from other publishers (6)

David G. Dolan, Joel P. Bercu, Jessica C. Graham & Ester L. Barle. 2003. Patty's Toxicology. Patty's Toxicology 1 39 .
Liliane Weber Bolfe Lamb, Gabriela Zimmermann Prado Rodrigues, Thalia Emmanoella Sebulsqui Saraiva, Douglas de Souza, Gabriel da Costa Berna, Ana Letícia Hilário Garcia, Fernando Bertoldi de Oliveira, Juliana Machado Kayser, Andriele Veiverberg, Mariana Roza Marco, Giulia Aline Führ, Günther Gehlen, Andresa Heemann Betti & Cristiane Bastos de Mattos. (2023) Permitted daily exposure from preclinical studies of Ginkgo biloba L. dry extract. Brazilian Journal of Pharmaceutical Sciences 59.
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Lisa Wiesner, Selene Araya & Ester Lovsin Barle. (2022) Identifying nonhazardous substances in pharmaceutical manufacturing and setting default health‐based exposure limits (HBELs). Journal of Applied Toxicology 42:9, pages 1443-1457.
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A. G. Solodovnikov, E. I. Morkovin, D. V. Kurkin, E. Yu. Sorokina & T. F. Peretolchina. (2022) Considerations for Permitted Daily Exposure Calculation for Contaminants in Medicinal Products Manufactured in Shared Facilities. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation 12:3, pages 300-309.
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Minshan Shou & Haixiao Qiu. (2021) Development of a rapid GC-FID method to simultaneously determine triethylamine, diisopropylamine, and 1,1,3,3-tetramethylguanidine residues in an active pharmaceutical ingredient. Journal of Pharmaceutical Analysis 11:2, pages 251-256.
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Ester Lovsin Barle, Thomas Pfister, Cornelia Fux, Dieter Röthlisberger, Dhananjay Jere & Hanns-Christian Mahler. (2019) Use of the permitted daily exposure (PDE) concept for contaminants of intravitreal (IVT) drugs in multipurpose manufacturing facilities. Regulatory Toxicology and Pharmacology 101, pages 29-34.
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