Comparison of permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs) - Evidence of a robust approach-Reference-Cited by-同舟云学术

Comparison of permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs) - Evidence of a robust approach

Published:2024-06 Issue: Volume:150 Page:105649
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

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

Publisher

Elsevier BV

Reference29 articles.

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2. E3219 - 20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs),2020

3. Point of departure (PoD) selection for the derivation of acceptable daily exposure (ADE) value for Active Pharmaceutical Ingredients (APIs);Bercu;Regul. Toxicol. Pharmacol.,2016

4. Potential impurities in drug substances: compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides;Bercu;Regul. Toxicol. Pharmacol.,2018

5. Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - current challenges and approaches;Broschard;Regul. Toxicol. Pharmacol.,2016

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