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...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Egile Nagusiak: Pourvasei, Ramak, Lee, Ed, Eschenberg, Michael, Patel, Vimal, Macaraeg, Chris, Pandya, Kinnari, Shih, Judy, Ma, Mark, Lee, Jean W., DeSilva, Binodh
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: Springer US 2012
Gaiak:
Research Article
Sarrera elektronikoa: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
Etiketak: Etiketa erantsi
Etiketarik gabe, Izan zaitez lehena erregistro honi etiketa jartzen!

Antzeko izenburuak