PHOENIX WINNONLIN WORKFLOWS SOFTWARE

PHOENIX WINNONLIN WORKFLOWS SOFTWARE

It is recognised for increasing productivity, improving workflows, and ensuring high accuracy for studies of drug action in the human body, said Ellen Leinfuss, CertaraвЂ™s Chief Commercial Officer. Reviewed workflows and calculations for ongoing studies to ensure regulatory and clinical compliance. ANVISA, MHRA and PMDA join EMA, FDA, NMPA and TGA in expanding their Phoenix software licenses to evaluate drug regulatory submissions PRINCETON, NJ Apr. Regulatory agencies, including the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), all use Phoenix WinNonlin to evaluate drug submissions. Phoenix WinNonlin is used by many Brazilian organisations to determine bioequivalence. Phoenix CDISC Workflow Templates are available for Phoenix users who require automated preparation of NCA Standard Data Tabulation Model (SDTM) clinical and Standard Exchange of Non-Clinical Data (SEND) nonclinical data sets in CDISC-ready formats. It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history. It is ideal for current users who perform PK non-compartmental analysis (NCA) in Phoenix WinNonlinВ®. Phoenix WinNonlin is used by over 6,000 scientists at more than 1,500 establishments in 60 countries. Phoenix WinNonlinв„ўвЂ™s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench. PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation.

Phoenix winnonlin workflows