Výsledky vyhledávání - "Ramak Pourvasei"

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules

Autor: Laura Brunner, Liana Zhang, Ramak Pourvasei, Mark Ma, Theingi M. Thway, Chris Macaraeg, Michael Eschenberg, Binodh DeSilva, Dominador Calamba

Publikováno v: Bioanalysis. 2:1587-1596

Background: Incurred sample reanalysis (ISR) is the most recent in-study validation parameter that regulatory agencies have mandated to ensure reproducibility of bioanalytical methods supporting pharmacokinetic/toxicokinetic and clinical studies. The

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c3cc0f1f8912df3d7b99cd5ee503db33
https://doi.org/10.4155/bio.10.75

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Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes

Autor: Binodh DeSilva, Ramak Pourvasei, Edward Lee, Vimal Patel, Kinnari Pandya, Judy Shih, Jean W. Lee, Mark Ma, Chris Macaraeg, Michael Eschenberg

Publikováno v: The AAPS journal. 15(1)

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

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb6262c0b50e736e1570a7d1fa349b2f
https://pubmed.ncbi.nlm.nih.gov/23054973

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