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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Dettagli Bibliografici
Autori principali: Pourvasei, Ramak, Lee, Ed, Eschenberg, Michael, Patel, Vimal, Macaraeg, Chris, Pandya, Kinnari, Shih, Judy, Ma, Mark, Lee, Jean W., DeSilva, Binodh
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer US 2012
Soggetti:
Research Article
Accesso online: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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