Working Group on Pharmacokinetics and Population Pharmacokinetics

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Examining the Role of Pharmacokinetics in Hemophilia

Presentation transcript:

Working Group on Pharmacokinetics and Population Pharmacokinetics Alfonso Iorio, MD, PhD, Professor of Medicine Department of Health Research Methods, Evidence, and Impact McMaster University, Canada

Acknowledgements Core working group Extended working group Alfonso Iorio Victor Blanchette Jan Blatny Peter Collins Kathelijn Fischer Ellis Neufeld David Lillicrap Daniel Hart Mike Makris Andrea Edginton Shinya Ito

ISTH SSC on Factor VIII and IX (1) Estimating and (2) interpreting (3) individual patients’ pharmacokinetic profiles in persons with Hemophilia A or B using a (4) population pharmacokinetic approach.

Acknowledgements External reviewers Pharma reviewers E. Berntorp, Malmö, Sweden; A. Boban, Zagreb, Croatia; M. Cnossen, Rotterdam, Netherlands; S.E. Croteau, Boston Children’s, USA; S. Jönsson, Uppsala University, SW; R. Mathot, AMC, Amsterdam, NL; M. Morfini, Florence, Italy; M. Ragni, Pittsburgh, USA. H. Agersؙø, Novo Nordisk A/S, Denmark; B. Beaufils, LFB, France; J. Feddern, Octapharma, Germany; M. Germer, Biotest, Germany; J. Korth-Bradley, Pfizer, US; S. Lethagen, Sobi, Sweden; J. Roberts, CSL Behring, US; A. Shah, Bayer, US; J. Spears, Grifols, USA; G. Spotts, Shire, Ireland.

25 guidance statements Practical recommendation for a limited sampling approach to individual PK profiling. Adopt testing conditions as close as possible to routine use of the factor concentrate. Select the most informative time points and record the sampling time precisely. Perform and record laboratory measurements precisely. Adopt an optimal Bayesian estimation technique for the individual PK profiling. Adopt a clinical perspective in the interpretation and use of the predicted PK profile

Future agenda Estimating and interpreting individual patients’ pharmacokinetic profiles in persons with Hemophilia A or B using a population pharmacokinetic approach: explanation, examples, and interpretation. Alfonso Iorio, Victor Blanchette, Jan Blatny, Peter Collins, Andrea Edginton, Kathelijn Fischer, Daniel Hart, Shinya Ito, David Lillicrap, Mike Makris, Ellis Neufeld.

Thank you !!! Join the WAPPS network at: www.wapps-hemo.org Download these slides at: Hemophilia.mcmaster.ca Thank you !!!