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Assessment of the Effects of Ionizing Radiation on Biologic Drugs: mAb Product Quality and Risk Evaluation for Global Shipping Logistics.

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Title: Assessment of the Effects of Ionizing Radiation on Biologic Drugs: mAb Product Quality and Risk Evaluation for Global Shipping Logistics.
Authors: Fuentes N; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA. nathalie.fuentes@astrazeneca.com., Suri A; Eurofins Lancaster Laboratories PSS Insourcing Solutions, 2430 New Holland Pike, Lancaster, PA, 17601, USA., Medina AM; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA., Moffett A; Eurofins Lancaster Laboratories PSS Insourcing Solutions, 2430 New Holland Pike, Lancaster, PA, 17601, USA., Patel A; Analytical Sciences, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA., Kwok SC; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
Source: Pharmaceutical research [Pharm Res] 2025 Jun; Vol. 42 (6), pp. 961-972. Date of Electronic Publication: 2025 May 16.
Publication Type: Journal Article
Journal Info: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Fuentes+N%22">Fuentes N</searchLink>; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA. nathalie.fuentes@astrazeneca.com.<br /><searchLink fieldCode="AU" term="%22Suri+A%22">Suri A</searchLink>; Eurofins Lancaster Laboratories PSS Insourcing Solutions, 2430 New Holland Pike, Lancaster, PA, 17601, USA.<br /><searchLink fieldCode="AU" term="%22Medina+AM%22">Medina AM</searchLink>; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.<br /><searchLink fieldCode="AU" term="%22Moffett+A%22">Moffett A</searchLink>; Eurofins Lancaster Laboratories PSS Insourcing Solutions, 2430 New Holland Pike, Lancaster, PA, 17601, USA.<br /><searchLink fieldCode="AU" term="%22Patel+A%22">Patel A</searchLink>; Analytical Sciences, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.<br /><searchLink fieldCode="AU" term="%22Kwok+SC%22">Kwok SC</searchLink>; Dosage Form Design and Development, BioPharmaceutical Development, R&D, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
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        Value: 10.1007/s11095-025-03867-7
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              Text: 2025 Jun
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