Scientific and Regulatory Policy Committee Points to Consider: Histopathologic Evaluation in Safety Assessment Studies for PEGylated Pharmaceutical Products

Colorless, intracytoplasmic vacuoles occur in multiple tissues in animals following repeated administration of polyethylene glycol (PEG)-conjugated molecules. The extent of vacuolation depends on physical characteristics and molecular backbone of the PEG and the dose, product, drug target/pharmacolo...

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Veröffentlicht in:	Toxicologic pathology 2018-08, Vol.46 (6), p.616-635
Hauptverfasser:	Irizarry Rovira, Armando R., Bennet, Bindu M., Bolon, Brad, Braendli-Baiocco, Annamaria, Chandra, Sundeep, Fleurance, Renaud, Garman, Robert, Hutto, David, Lane, Joan, Romeike, Annette, Sargeant, Aaron, Zimmerman, Bevin
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Consumer Product Safety - standards Drug Evaluation, Preclinical - standards Drug-Related Side Effects and Adverse Reactions - etiology Drug-Related Side Effects and Adverse Reactions - pathology Organ Specificity Pharmaceutical Preparations - chemistry Pharmaceutical Preparations - metabolism Policy Making Polyethylene Glycols - chemistry Polyethylene Glycols - pharmacokinetics Polyethylene Glycols - toxicity Tissue Distribution Vacuoles - drug effects Vacuoles - metabolism Vacuoles - ultrastructure
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