AN INTERACTIVE TECHNIQUE FOR OPTIMIZING DRUG DEVELOPMENT FROM THE PRE-CLINICAL PHASES THROUGH PHASE-IV

摘要

A method of performing interactive clinical trials for testing a new drug comprising performing a pre-clinical phase in which a computer model for pharmacokinetics and pharmacodynamics of the drug is created and adjusted based on the in vitro studies and in vitro studies in animals. A phase I clinical research is performed in which a clinical trial on at least a single dose is performed in parallel with performing computer simulation studies using the computer model. The computer model is adjusted based on comparison of the results of the clinical research and the computer simulation. The drug is checked for cumulative effects and providing this information to the computer model.