Pharmacokinetic Modeling and Predictive Performance: Practical Considerations for Therapeutic Monoclonal Antibodies

Author:

Chen YangORCID,Li Joshua,Li Derry,Hu Chuanpu

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference18 articles.

1. Williams P, Ette E. Pharmacometrics: impacting drug development and pharmacotherapy. In: Ette E, Williams P, editors. Pharmacometrics: the science of quantitative pharmacology. Hoboken: John Wiley & Sons Inc.; 2007. p. 1–21.

2. Xu Y, Kimko H. Pharmacometrics: a quantitative decision-making tool in drug development. In: Marchenko OV, Katenka NV, editors. Quantitative methods in pharmaceutical research and development. Berlin: Springer Press; 2020. p. 71–104.

3. US Food and Drug Administration (USFDA). Population Pharmacokinetics. Food and Drug Administration-Guidance for Industry. 2019. https://www.fda.gov/media/128793/download.pdf. Accessed 28 Dec 2020.

4. US Food and Drug Administration (USFDA). General clinical pharmacology considerations for pediatric studies for drugs and biological products—Guidance for Industry. December 2014. https://www.fda.gov/media/90358/download. Accessed 28 Dec 2020.

5. Grist B, Zheng S, Xu Y. Therapeutic antibody development—remington chapter. In: Adeboye A, editor. Remington. Cambridge: Academic Press; 2021. p. 437–62.

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