FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

The pharmaceutical industry is actively applying quantitative systems pharmacology (QSP) to make internal decisions and guide drug development. To facilitate the eventual development of a common framework for assessing the credibility of QSP models for clinical drug development, scientists from US F...

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Vydané v:	The AAPS journal Ročník 23; číslo 3; s. 60
Hlavní autori:	Bai, Jane P. F., Schmidt, Brian J., Gadkar, Kapil G., Damian, Valeriu, Earp, Justin C., Friedrich, Christina, van der Graaf, Piet H., Madabushi, Rajanikanth, Musante, Cynthia J., Naik, Kunal, Rogge, Mark, Zhu, Hao
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Cham Springer International Publishing 30.04.2021
Predmet:	Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Meeting Report Pharmacology/Toxicology Pharmacy drug development quantitative systems pharmacology pharmacodynamics model calibration and validation model assessment
ISSN:	1550-7416, 1550-7416
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