US 11,670,409 B2
Method and apparatus for providing a pharmacokinetic drug dosing regiment
Kameswara Rao Kuchimanchi, Lexington, MA (US); Alexandra Loew-Baselli, Vienna (AT); Gerald Spotts, Encino, CA (US); Myungshin Oh, Los Angeles, CA (US); Michael Don Hale, Winchester, MA (US); and Martin Wolfsegger, Vienna (AT)
Assigned to TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
Appl. No. 16/92,396
Filed by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
PCT Filed Apr. 13, 2017, PCT No. PCT/US2017/027309
§ 371(c)(1), (2) Date Oct. 9, 2018,
PCT Pub. No. WO2017/180807, PCT Pub. Date Oct. 19, 2017.
Claims priority of provisional application 62/323,015, filed on Apr. 15, 2016.
Prior Publication US 2020/0312436 A1, Oct. 1, 2020
Int. Cl. G16H 20/17 (2018.01); G16H 50/70 (2018.01); G16H 50/20 (2018.01); G16C 20/30 (2019.01); G16H 50/50 (2018.01); G16C 20/50 (2019.01); G16C 20/70 (2019.01); A61P 7/04 (2006.01); A61K 49/00 (2006.01); G06N 7/01 (2023.01)
CPC G16H 20/17 (2018.01) [G16C 20/30 (2019.02); G16H 50/20 (2018.01); G16H 50/50 (2018.01); G16H 50/70 (2018.01); A61K 49/0004 (2013.01); A61P 7/04 (2018.01); G06N 7/01 (2023.01); G16C 20/50 (2019.02); G16C 20/70 (2019.02)] 15 Claims
 
1. A method for providing a clotting factor VIII dosing regimen comprising:
determining a clotting factor VIII clearance for a patient based on two blood samples collected from the patient after an infusion of clotting factor VIII;
determining if a patient has a half-life greater than a predetermined threshold;
determining, via a processor, an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients, the estimated pharmacokinetic profile based upon at least one of a body weight or an age of the patient such that:
a first weighting factor is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is greater than the predetermined threshold, and
a second weighting factor, less than the first weighting factor, is applied to the Bayesian model of pharmacokinetic profiles of sampled patients if the half-life of the patient is less than the predetermined threshold;
determining, via the processor, a dosing regimen for a specified dosing interval including (i) a dosage and (ii) an estimated clotting factor VIII clearance for the patient over a time period based at least upon the estimated pharmacokinetic profile;
displaying the dosing regimen on a client device; and
administering clotting factor VIII based on the dosing regimen.