The Potential Clinical Relevance of Visible Particles in Parenteral Drugs

Visible particulates (VP) are one subclass of defects seen during the final visual inspection of parenteral products and are currently one of the top ten reasons for recalls 1,2. The risk posed by particles is still unclear with limited experience reported in humans but remains an important consider...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2012-08, Vol.101 (8), p.2635-2644
Hauptverfasser:	Doessegger, Lucette, Mahler, Hanns-Christian, Szczesny, Piotr, Rockstroh, Helmut, Kallmeyer, Georg, Langenkamp, Anja, Herrmann, Joerg, Famulare, Joseph
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological and medical sciences distribution Drug and Narcotic Control Drug-Related Side Effects and Adverse Reactions General pharmacology Humans Infusions, Parenteral injectables Injections Medical sciences Parenteral Nutrition - adverse effects Particle Size particles Particulate Matter - administration & dosage Particulate Matter - adverse effects Particulate Matter - chemistry Pharmaceutical Preparations - administration & dosage Pharmaceutical Preparations - chemistry Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments physicochemical properties precipitation Pulmonary Embolism - chemically induced regulatory science Respiratory Distress Syndrome, Adult - chemically induced thromboembolism toxicity Transfusion Reaction
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