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Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes
Manufacturing changes during a biological drug product life cycle occur often; one common change is that of the manufacturing site. Comparability studies may be required to ensure that the changes will not affect the pharmacokinetic properties of the drug. In addition, the bioanalytical method for s...
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| Main Authors: | , , , , , , , , , |
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| Format: | Artigo |
| Sprog: | Inglês |
| Udgivet: |
Springer US
2012
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| Fag: | |
| Online adgang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3535110/ https://ncbi.nlm.nih.gov/pubmed/23054973 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-012-9414-x |
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