Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE)
Author:
Affiliation:
1. Novartis Pharma AG, Postfach, Basel, Switzerland
Publisher
Informa UK Limited
Subject
Pharmaceutical Science,General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/10837450.2017.1334665
Reference32 articles.
1. Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs)
2. Nature of spontaneous tympanic membrane perforation in acute otitis media in children
3. Daiichi Sankyo Pharma. 2010. Prescribing Information LOXIN® Otic (ofloxacin otic solution) 0.3%. Revised Document 02-2010. Edison (NJ): Daiichi Sankyo Pharma Development, a division of Daiichi Sankyo, Inc.; 08837.
4. Ototoxicity of Topical Moxifloxacin in a Chinchilla Animal Model
5. European Medicines Agency (EMA). 2014. Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities EMA/CHMP/CVMP/SWP/169430/2012 [Internet]. [Cited 2017 May 31]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177735.pdf
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