Modeling Successful Phase 3 Trials
Pharmacometrics optimizes the use of Phase 2 data to support Phase 3 success.
Pharmacometrics optimizes the use of Phase 2 data to support Phase 3 success.
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― 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
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
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
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.