Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices.

Bai, Jane P F; Earp, Justin C; Pillai, Venkateswaran C

Bai, Jane P F; Earp, Justin C; Pillai, Venkateswaran C.

Affiliation

Bai JPF; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA. Jane.bai@fda.hhs.gov.
Earp JC; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.
Pillai VC; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20903, USA.

AAPS J ; 21(4): 72, 2019 06 03.

Article in En | MEDLINE | ID: mdl-31161268

Subject(s)

Drug Development/methods; Models, Biological; Pharmacology/methods; Systems Biology/methods; Translational Research, Biomedical/methods; Drug Development/standards; Drugs, Investigational/pharmacology; Humans; Translational Research, Biomedical/standards

Key words

best practices; biomarkers; life cycle of QSP models; model assessment; virtual patients

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Full text: 1 Collection: 01-internacional Health context: 1_ASSA2030 Database: MEDLINE Main subject: Pharmacology / Systems Biology / Translational Research, Biomedical / Drug Development / Models, Biological Type of study: Prognostic_studies Limits: Humans Language: En Journal: AAPS J Year: 2019 Document type: Article

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