Current Edition

Early-Phase Drug Development Strategies to Inform Decision-Making in the Viability of Novel CNS Compounds for Schizophrenia

The need to improve and accelerate the success of drug development in schizophrenia has resulted in the increased utilisation of novel pharmacodynamic methodologies that may readily translate from preclinical models to patients, and provide informative data predictive of clinical efficacy. Brett A. English and his team at PAREXEL International explain how the incorporation of pharmacodyamic biomarkers, including the use of patients earlier in Phase I trials, may provide useful strategies to predict antipsychotic efficacy during later proof-of-concept (POC) trials.