Use of the permitted daily exposure (PDE) concept for contaminants of intravitreal (IVT) drugs in multipurpose manufacturing facilities

Author:

Lovsin Barle EsterORCID,Pfister Thomas,Fux Cornelia,Röthlisberger Dieter,Jere Dhananjay,Mahler Hanns-Christian

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference44 articles.

1. Standard Guide for the Derivation of Health Based Exposure Limits (HBELs) WK59975;ASTM,2018

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3. Principles of pharmacology in the eye;Awwad;Br. J. Pharmacol.,2017

4. Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation;Ball;Toxicol. Sci. Off. J. Soc. Toxicol.,2007

5. Advancing toxicology in RiskMAPP: setting ADEs based on the subsequent drug substance;Bercu;Regul. Toxicol. Pharmacol.,2013

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