This series of blog posts describes some of the benefits of partnering with Nuventra to meet your PK/PD needs in drug development. In this post we look at Renal Impairment analysis.
Renal Impairment Analysis – Using modeling compared to running a stand-alone study
- Nuventra prepared a white paper and clinical pharmacology plan for a client and argued that data already collected from patients in prior clinical trials of their compound could be analyzed to determine the effect of renal function on the compound’s pharmacokinetics. This retrospective analysis and overall clinical pharmacology plan was well received by regulatory agencies and allowed the client to avoid a standalone renal impairment study without sacrificing important information for the future product label.
Take home message
Engage a skilled Pharmacokineticist early in drug development (during IND-enabling studies) to save time and money for your drug.
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