Pharmacokinetic Bridging Approach for Developing Biologics-delivery Devices: A Case Study With a Gol...
Pharmacokinetic Bridging Approach for Developing Biologics-delivery Devices: A Case Study With a Golimumab Autoinjector
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Publisher
United States: Elsevier Inc
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Language
English
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Publisher
United States: Elsevier Inc
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Abstract Purpose This Phase 1 pharmacokinetic (PK) comparability study in healthy subjects was performed to compare the PK properties and tolerability of single-dose golimumab 100 mg delivered subcutaneously by an autoinjector device or by a standard needle and syringe that had been used for the subcutaneous (SC) delivery of golimumab in pivotal Ph...
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Full title
Pharmacokinetic Bridging Approach for Developing Biologics-delivery Devices: A Case Study With a Golimumab Autoinjector
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TN_cdi_proquest_miscellaneous_1660414291
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https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_1660414291
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ISSN
0149-2918
E-ISSN
1879-114X
DOI
10.1016/j.clinthera.2014.09.012
