Submission Support – PK & PK/PD

Case Study

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Population PK and PKPD modeling
For drug registration

Goal: Support regulatory filings with dedicated PK and PK/PD analyses  

Available information

  • Client provided analysis data containing information from several Phase 1, Phase 2, and Phase 3 studies

Challenge

  • Time from availability of final data to 3 required finalized analysis reports was 7 weeks

Approach

  • Population PK analysis
  • Efficacy & safety exposure response analyses
  • Several full regulatory analysis reports (PK, PK/PD efficacy, PK/PD safety)

Benefit for the Client

  • High quality efficient conduct of all analyses
  • Despite changes in the original source data 3 weeks prior to submission IntiQuan was able to ensure the timely delivery of all results and reports
  • No questions by FDA

R based PK/PD modeling workflow

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Reproducible Analyses

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