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Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – Current challenges and approaches

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Year: 2016
Type: article
Source: Regulatory Toxicology and Pharmacology
DOI: 10.1016/j.yrtph.2016.08.011
Authors: Thomas H. Broschard, Susanne Glowienke, Uma S. Bruen, Lee M. Nagao, Andrew Teasdale, Cheryl L.M. Stults, Kim L. Li, Laurie A. Iciek, Greg Erexson, Elizabeth A. Martin, Douglas J. Ball
Institutions: Merck KGaA, Darmstadt (Germany), Novartis (Switzerland), Merck & Co., Inc., Rahway, NJ, USA (United States), AstraZeneca (United Kingdom), Amgen (United States), AbbVie (United States), Pfizer (United States)
Language: English

Topic: Analytical Methods in Pharmaceuticals
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
SDG: Good health and well-being

Open Access status: closed
OpenAlex ID: W2512138876
FWCI: 4.212
Cites: 40
Cited by: 71
Related to: 10
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