Pre-clinical Group Automates 90% of Their PK Analyses and Report Generation

Learn how the pre-clinical group at Gilead saved time and money by using Certara’s Phoenix WinNonlin and Phoenix Connect.

Gilead Sciences, Inc., a global pharmaceutical company, has developed drugs to treat a range of diseases including HIV/AIDS, hepatitis, and cancer. The pre-clinical group at Gilead characterized the pharmacokinetic (PK) profiles of early stage compounds in animal models. The majority of their pre-clinical PK studies involved acute administration of the compound to an animal followed by serial blood sampling. Next, bioanalytical methods were used to measure plasma drug concentrations. Finally, the bioanalytical data were analyzed to characterize the PK profile of the drug. Their routine analysis included generation of a non-compartmental analysis (NCA) model to determine PK parameters such as area under the curve (AUC), clearance, maximum concentration (Cmax), and half-life.

They had previously used Microsoft® Excel® to perform PK analyses. However, this was not an ideal solution for several reasons. First, Excel macros often generated different results depending on which analyst conducted the study. Second, user errors often occurred when using Excel. For example, Excel macros could not be customized to import only the crucial PK raw data from the bioanalytical instruments, which could potentially result in incorrect calculations of PK parameters. Finally, when generating reports, analysts had to manually cut and paste tables, listings, and figures (TLFs) into their Microsoft® Word® reports – an inefficient, time-consuming, and potentially error-prone process! Since this group of scientists often conducted dozens of pre-clinical PK studies every month, they were interested in a more streamlined solution for PK analysis and report-generation.

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