Method and apparatus for providing a pharmacokinetic drug dosing regiment

US11670409B2 · kind B2 · utility

Assignee

• Takeda Pharmaceutical Company Limited · JP

Inventors

• Kameswara Rao Kuchimanchi · Lexington, US
• Alexandra Loew-Baselli · Wien, AT
• Gerald Spotts · Lexington, US
• Myungshin Oh · Los Angeles, US
• Michael Don Hale · Raleigh, US
• Martin Wolfsegger · Wien, AT

Key dates

• Filing date: Apr 13, 2017
• Grant date: Jun 6, 2023
• Expiry date: Oct 4, 2040

Classification

• Technology area (CPC G): Physics
• CPC primary: G16C20/70
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

Systems and methods for providing a clotting factor VIII (CFVIII) dosing regimen include collecting two blood samples from a patient after an infusion of CFVIII and determining a CFVIII clearance based on the two blood samples, and determining if a patient has a half-life greater than a predetermined threshold. A pharmacokinetic (PK) profile of the patient is determined using a Bayesian model of pharmacokinetic profiles of sampled patients having similar body weight or age of the patient. A first weight 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 weight, less than the first weight, 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. A dosing regimen is determined for the patient based on the PK profile.