换一批Bioanalytical strategy used in development of pharmacokinetic (PK) methods that support biosimilar programs.
第一作者：
Alex,Colbert
第一单位：
a Department of Pharmacokinetics and Drug Metabolism ; Amgen Inc. ; USA.
作者：
关键词
ART, ambient room temperatureAvg, AverageBE, bioequivalenceBQL, Below the Quantification LimitCV, Coefficient of VariationECL, ElectrochemiluminescentLLOQ, Lower Limit of QuantificationMRD, minimum required dilutionMSD, Meso Scale DiscoveryPD, pharmacodynamicsPK, pharmacokineticTPA, TripropylamineULOQ, Upper Limit of Quantificationbioanalyticalbiosimilarbiotherapeuticscomparabilitypharmacodynamicspharmacokineticrecombinant
医学主题词
动物(Animals);生物制品(Biological Products);药物发现(Drug Discovery);药物监测(Drug Monitoring);人类(Humans);质量控制(Quality Control);参考标准(Reference Standards);工艺学, 制药(Technology, Pharmaceutical);治疗等效(Therapeutic Equivalency)
DOI
10.4161/mabs.32114
PMID
25517303
发布时间
2024-03-24
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