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. It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history. Phoenix WinNonlin is used by over 6,000 scientists at more than 1,500 establishments in 60 countries. Phoenix WinNonlin™’s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench. Phoenix templates make performing RSABE in WinNonlin much easier and faster than performing manual coding. While many drugs are highly variable, RSABE is a method for demonstrating BE for regulatory agencies without spending excessive time and money on large sample sizes. PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation. Leverage Phoenix RSABE templates to support approvals of HV drugs.
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