Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.
Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded industry professionals.
In this blog we share the Cytel contributed poster sessions:
Cecilia Fosser, Director of QPP and Phase 1 Biostatistics
“Identifying Efficacious Thresholds for Bleeding Risk Reduction in Hemophilia (study)”.
Factor IX (FIX) replacement is effective therapy for hemophilia B patients. The current clinical rationale for keeping higher trough levels of FIX is so that patients with severe hemophilia (FIX <1%) transition to moderate (FIX of 1-5%) or mild disease states (FIX >5%).
An analysis was done to robustly define the FIX exposure versus outcome relationship and to quantitatively ascertain the reduction in risk of having a bleeding event to specific FIX levels.
The objective of the study was to understand the relationship between rIX-FP (FIX activity) exposure and the re-occurrence of bleeding episodes in patients with severe hemophilia B.
Nand Kishore Rawat, Director, Biostatistics
“Model-based Meta-Analysis (MBMA) of PK Drug Interactions: Run One, Know Everything”.
Pharmacokinetic drug-drug interactions (DDI) are important to consider during clinical development to ensure safety both for the current drug and for concomitant medications. DDI studies are usually conducted during Phase 1 or 2 for commonly co-administered therapies and during Phase 3 for reference and narrow-therapeutic-index therapies . Physiologically Based Pharmacokinetic (PBPK) models are accepted in FDA guidance for prediction of CYP3A interactions and for guidance on other CYP interactions, but limitations remain with PBPK for other interactions .
The objective of the work is to develop a MBMA for DDI to many DDI from a small set of clinical results.
If you would like to download the posters, please click here.
- US FDA (February 2012). Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labelling.