1. 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

2. 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

3. 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.

4. 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.

5. 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

6. 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.

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