Modeling Successful Phase 3 Trials
Pharmacometrics optimizes the use of Phase 2 data to support Phase 3 success.
Month: March 2016
Certara’s Synchrogenix Unit Provides Solution to Enable Pharma Compliance with EMA Policy 70
PRINCETON, NJ – Mar. 24, 2016 – Synchrogenix has introduced an artificial intelligence (AI) -enabled solution to meet the data transparency requirements of the clinical and drug development market.
Precision Dosing Using PBPK Modeling
Precision dosing― the right dose, for the right patient, at the right time― is crucial to providing patients with the most efficacious medications with minimal probability of adverse events. One key step towards achieving the delivery of individualized dosing is testing potential dosing regimens in a patient’s ‘virtual twin.’ The other key step is to … Continued
Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data
Humans differ from commonly used pre-clinical model organisms (rats, dogs, monkeys) in terms of their biochemistry, physiology, and anatomy. Predicting a drug’s pharmacokinetic (PK) profile in humans using animal PK data must account for these differences. Allometric scaling is used to predict human PK parameters based on animal data. While allometric scaling has been used … Continued
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3 pertains to quality data. It has become increasingly common for sponsors to reference a Drug Master File (DMF) within this module. A DMF contains detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs … Continued
Aripiprazole Lauroxil Pharmacokinetics: Application of Modeling and Simulation for Dosing Considerations of a Long-acting Injectable Antipsychotic in Persons with Schizophrenia
Predicting the Impact of CYP3A5 Polymorphism on Tacrolimus Trough Concentrations in Black African Transplant Recipients
Application of PBPK Modeling to Assess the Victim DDI Potential of Paclitaxel in Oncology Combination Therapies
Exploring the Hypothesis that Age-related Differences in the Response to Triazolam are Due to Altered Pharmacokinetics and Increased Sensitivity to the Drug in the Elderly
Certara Scientists to Participate in 12 Sessions at the ASCPT 2016 Annual Meeting
PRINCETON, NJ – 2016 年 3 月 4 日 – Certara scientists will be participating in 12 sessions at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2016 Annual Meeting in San Diego, CA.
