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New horizons of model informed drug development in rare diseases drug development
A Mitra, N Tania, MA Ahmed, N Rayad… - Clinical …, 2024 - Wiley Online Library
Model‐informed approaches provide a quantitative framework to integrate all available
nonclinical and clinical data, thus furnishing a totality of evidence approach to drug …
nonclinical and clinical data, thus furnishing a totality of evidence approach to drug …
PBPK Modeling: Empowering Drug Development and Precision Dosing in China
Physiologically based pharmacokinetic (PBPK) modeling, a cornerstone of model‐informed
drug development and model‐informed precision dosing, simulates drug disposition in the …
drug development and model‐informed precision dosing, simulates drug disposition in the …
Translational pharmacokinetic/pharmacodynamic model for mRNA‐0184, an investigational therapeutic for the treatment of heart failure
Heart failure (HF) is a complex, progressive disorder that is associated with substantial
morbidity and mortality on a global scale. Relaxin‐2 is a naturally occurring hormone that …
morbidity and mortality on a global scale. Relaxin‐2 is a naturally occurring hormone that …
A quantitative systems pharmacology (QSP) platform for preclinical to clinical translation of in-vivo CRISPR-Cas therapy
Background: In-vivo CRISPR Cas genome editing is a complex therapy involving lipid
nanoparticle (LNP), messenger RNA (mRNA), and single guide RNA (sgRNA). This novel …
nanoparticle (LNP), messenger RNA (mRNA), and single guide RNA (sgRNA). This novel …
Translational PK–PD model for in vivo CAR‐T‐cell therapy delivered using CAR mRNA‐loaded polymeric nanoparticle vector
Autologous chimeric antigen receptor (CAR) T‐cell therapy has demonstrated remarkable
response rates, yet its widespread implementation is hindered by logistical, financial, and …
response rates, yet its widespread implementation is hindered by logistical, financial, and …
Future Directions for Quantitative Systems Pharmacology
B Schoeberl, CJ Musante, S Ramanujan - 2025 - Springer
In this chapter, we envision the future of Quantitative Systems Pharmacology (QSP) which
integrates closely with emerging data and technologies including advanced analytics, novel …
integrates closely with emerging data and technologies including advanced analytics, novel …