model selection, etc), the presentation of results should not be underestimated the visual appearance of data plays a key role in facilitating a clear understanding of whether or not key study objectives have been attained. Our capabilities in pharmacokinetics include early exploratory, investigative or screening studies, juvenile studies, disease model studies and formal studies that support a regulatory submission. Devising robust procedures using SAS transport files and CDISC nomenclature enables a readily switch between Phoenix WinNonlin and SAS (not to mention other software packages such as NONMEM ) to produce TLFs in a format which is suitable for each individual study’s reporting requirements. Although the main aspect of any PK analysis should be ensuring that the correct approach has been used (e.g. The goal of animal model studies is to mimic the infectious diseases seen in humans to allow for robust PK/PD studies to find the optimal drug exposures that lead to therapeutic success. Phoenix WinNonlin’s advanced reporting capabilities are very useful when compiling stand-alone PK reports, facilitating rapid illustration of PK data through workflows and templates however, when results are integrated into a large CSR, it is often preferable to generate TLFs in SAS for consistency with the remainder of the clinical report (e.g.
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