Month: 2019年4月
Improving Clinical Translation of Neuroblastoma Treatment Effects by Integration of Preclinical Experimental Innovation and Computational Modeling
Simulating the Impact of the Interplay Between CYP2C19 Polymorphisms and Ethnicity on Response to Clopidogrel, Using PBPK-PD Models
Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics
Exposure-Response Analyses to Support Dose Justification of DS-8201A, A HER2-Targeting Antibody-Drug Conjugate, in HER2-Positive Breast Cancer Patients
Relationship of Ivosidenib Plasma Concentration to Heart Rate-Corrected QT Interval in Patients with IDH1-Mutant Advanced Hematologic Malignancies
Validation of the Pharmacokinetic/Pharmacodynamic Model Used for Dose Selection of Andexanet Alfa for Reversal of Anticoagulation
Evaluation of Maternal Drug Exposure Following Administration of Dexamethasone and Betamethasone During Pregnancy Using Physiologically-Based Pharmacokinetic Modeling
Certara Adds 4 Global Leaders to its Simcyp PBPK, QSP and QSTS M&S Division
New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.
Global Regulatory Agencies Increase Adoption of Phoenix PK/PD M&S Software for Drug Reviews
PRINCETON, NJ – Apr. 4, 2019- ANVISA, MHRA and PMDA join EMA, FDA, NMPA and TGA in expanding their Phoenix software licenses to evaluate drug regulatory submissions
