US 11,749,394 B2
Method and apparatus for providing a pharmacokinetic drug dosing regimen
Kameswara Rao Kuchimanchi, Lexington, MA (US); Alexandra Loew-Baselli, Vienna (AT); Gerald Spotts, Encine, 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)
Filed by TAKEDA PHARMACEUTICAL COMPANY LIMITED, Osaka (JP)
Filed on Jul. 13, 2021, as Appl. No. 17/374,315.
Application 17/374,315 is a continuation of application No. 17/070,599, filed on Oct. 14, 2020, granted, now 11,081,211.
Application 17/070,599 is a continuation of application No. 16/092,396, previously published as PCT/US2017/027309, filed on Apr. 13, 2017.
Application 17/070,599 is a continuation in part of application No. 14/311,113, filed on Jun. 20, 2014, abandoned.
Claims priority of provisional application 62/323,015, filed on Apr. 15, 2016.
Claims priority of provisional application 61/881,214, filed on Sep. 23, 2013.
Claims priority of provisional application 61/840,969, filed on Jun. 28, 2013.
Claims priority of provisional application 61/837,421, filed on Jun. 20, 2013.
Prior Publication US 2021/0343375 A1, Nov. 4, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 20/17 (2018.01); G16H 50/70 (2018.01); G16H 50/50 (2018.01); G16H 50/20 (2018.01); G16C 20/30 (2019.01); 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)] 13 Claims
OG exemplary drawing
 
1. A method comprising:
determining, via a processor, an estimated pharmacokinetic (PK) profile of a patient using a Bayesian model of PK profiles of sampled patients;
determining, via the processor, a first dosing regimen for a first specified dosing interval in response to receiving at least one of a selected minimum therapeutic plasma protein level, a selected dosing interval, or a selected dosage amount of a therapeutic plasma protein, wherein:
the first dosing regimen is associated with a first time-varying therapeutic plasma protein level in the patient that is based at least upon the estimated PK profile, and
the at least one of the selected minimum therapeutic plasma protein level, the selected dosing interval, or the selected dosage amount is received at the processor via a graphical user interface (GUI) that includes fields for user input for adjusting at least one of the selected minimum therapeutic plasma protein level, the selected dosing interval, or the selected dosage amount; and
determining, via the processor, if the patient has a therapeutic plasma protein half-life greater than a predetermined threshold, wherein:
a first weighting factor is applied to the Bayesian model of PK 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 PK profiles of sampled patients if the half-life of the patient is less than the predetermined threshold.