Probablistic pharmacokinetic and pharmacodynamic modeling

• US 8,540,664 B2
• Filed: 03/24/2010
• Issued: 09/24/2013
• Est. Priority Date: 03/25/2009
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Robertson, Timothy, Behzadi, Yashar
• Primary Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US13/260,073
• Publication Number:
  US 20120022443A1
• Time in Patent Office: 1,280 Days
• Field of Search: 604 65- 66, 600301-302, 340/10.1, 340/539.12, 340/572.1
• US Class Current: 604/65
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The subject matter disclosed herein provides a response to a dose of a substance and/or controls the administration of the dose. In one aspect, there is provided a system. The system may include a processor and at least one memory configured to provide a response determinator. The response determinator may receive therapeutic and wellness data. Moreover, the response determinator may determine a response based on the received therapeutic and wellness data. The response may represent a reaction to a substance integrated with an ingestible event marker. The determined response may be provided to, for example, a therapy controller. Related systems, methods, and articles of manufacture are also described.

Claims

1. A system comprising:

a processor; and

at least one memory, the processor and the at least one memory configured to provide a response determinator to;

receive therapeutic and wellness data;

determine, based on the received therapeutic and wellness data, a response representing a reaction to a substance integrated with an ingestible event marker; and

provide the determined response; and

wherein the response determinator determines the response as a response matrix, H, according to the following equation;

H=(A^TA)<sup>−

1</sup>A^TY,

wherein A represents one or more times that a dose of the substance is ingested, A^T represents a transpose of matrix A, (A^T A)<sup>−

1</sup> represents an inverse of a matrix multiplication of matrix A and matrix A^T, and Y represents a matrix of observations including the therapeutic and wellness data.

2. The system of claim 1, wherein the therapeutic and wellness data includes ingestible event marker data received from the ingestible event marker integrated with the substance, the ingestible event marker providing a signal when the substance is ingested.

3. The system of claim 1, wherein the therapeutic and wellness data includes data representative of physiological aspects associated with the ingestion of the ingestible event marker and the substance.

4. The system of claim 1, wherein the therapeutic and wellness data includes one or more of the following:

an ingestion time;

an identification of the substance;

an expiration date of the substance;

a dosage amount for the substance;

one or more physiological parameters associated with the reaction to at least one dose of the substance;

a dosage of an intravenous substance;

a heart rate;

a blood pressure measurement;

an optical measurement;

a body temperature;

a weight;

an amount of an inhalant;

an inhalation time;

an identity of an inhaled substance;

a galvanic skin response;

an insertion time; and

a drinking time.

5. The system of claim 1, wherein the response determinator determines the response as a function of the therapeutic and wellness data.

6. The system of claim 1 further comprising:

a therapy controller configured to control, based on the response, at least one of an amount the substance and a time of the substance is ingested.

7. A system comprising:

a processor; and

at least one memory, the processor and the at least one memory configured to provide a therapy controller to;

receive a response representing a reaction to a substance integrated with an ingestible event marker;

receive therapeutic and wellness data; and

control, based on the received response and the received therapeutic and wellness data, at least one of a dose of the substance and a time of the dose of the substance;

wherein the response is determined as a response matrix, H, according to the following equation;

H=(A^TA)<sup>−

1</sup>A^TY,

wherein A represents one or more times that a dose of the substance is ingested, A^T represents a transpose of matrix A, (A^TA)<sup>−

1</sup> represents an inverse of a matrix multiplication of matrix A and matrix A^T, and Y represents a matrix of observations including the therapeutic and wellness data.

8. The system of claim 7, wherein the therapy controller uses a closed-loop to control at least one of the dose of the substance and the time of the dose of the substance.

9. The system of claim 7, wherein the therapy controller uses a closed-loop to vary an input to the response to generate an output of the response, the output corresponding to at least one of the dose of the substance and the time of the dose of the substance.

10. The system of claim 7, wherein the ingestible event marker data are received from the ingestible event marker integrated with the substance, the ingestible event marker providing a signal when the substance is ingested.

11. The system of claim 7, wherein the therapeutic and wellness data represents physiological aspects associated with the ingestion of the ingestible event marker and the substance.

12. The system of claim 7, wherein the response is determined based on the reaction of at least one of an individual patient, a population, and a subset of the population.

13. The system of claim 7, wherein the response is determined as a function of the therapeutic and wellness data.