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