Probablistic Pharmacokinetic and Pharmacodynamic Modeling

• US 20130338628A1
• Filed: 05/08/2013
• Published: 12/19/2013
• 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 L., Behzadi, Yashar
• Granted Patent: US 9,119,918 B2
• Time in Patent Office: Days
• US Class Current: 604/503
• 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

1-20. -20. (canceled)

21. A system comprising:

a processor; and

at least one memory, the processor and the at least one memory configured to;

receive dose event data A;

receive observations of therapeutic and wellness data Y; and

determine, based on the received observations of therapeutic and wellness data and the received dose event data, a response H representing a reaction to a substance integrated with an ingestible event marker, according to the following equation;

Y=A H;

wherein Y represents a matrix of observations of therapeutic and wellness data, A represents a matrix of dose event data, and H represents a response matrix.

22. The system of claim 21, 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.

23. The system of claim 21, wherein the dose events matrix A represents a number of times when an ingestible event marker signaled that a dose was taken.

24. The system of claim 23, wherein the dose events of the matrix A are represented as real time values of when the doses are taken.

25. The system of claim 24, wherein the real time values are represented as actual time values of when the doses are taken.

26. The system of claim 23, wherein the dose events of the matrix A are represented as binary values of when the doses are taken.

27. The system of claim 26, wherein a first binary value represents that no dosing event was detected and a second binary value represents that a dosing event was detected.

28. The system of claim 21, wherein the therapeutic and wellness data includes data representative of physiological aspects associated with the ingestion of the ingestible event marker and the substance.

29. The system of claim 21, 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.

30. The system of claim 21, comprising:

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

31. A system comprising:

a processor;

at least one memory, the processor and the at least one memory configured to;

receive dose event data A;

receive observations of therapeutic and wellness data Y; and

determine, based on the received observations of therapeutic and wellness data and the received dose event data, a response H representing a reaction to a substance integrated with an ingestible event marker, according to the following equation;

Y=A H;

wherein Y represents a matrix of observations of therapeutic and wellness data, A represents a matrix of dose event data, and H represents a response matrix; and

a therapy controller to control, based on the response data and the therapeutic and wellness data, at least one of a dose of the substance and a time of the dose of the substance.

32. The system of claim 31, wherein the therapy controller is configured to control at least one of the dose of the substance and the time of the dose of the substance using a closed-loop.

33. The system of claim 31, wherein the therapy controller is configured to vary an input to the response to generate an output of the response using a closed-loop, the output corresponding to at least one of the dose of the substance and the time of the dose of the substance.

34. The system of claim 31, 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.

35. The system of claim 31 wherein the therapeutic and wellness data represent physiological aspects associated with the ingestion of the ingestible event marker and the substance.

36. The system of claim 31, wherein the response data is determined based on the reaction of at least one of an individual patient, a population, and a subset of the population.

37. A method comprising:

receiving, by a processor and at least one memory coupled to the processor, dose event data A;

receiving, by the processor and the at least one memory coupled to the processor, observations of therapeutic and wellness data Y; and

determining, by the processor and the at least one memory coupled to the processor, based on the received observations of therapeutic and wellness data and the received dose event data, a response H representing a reaction to a substance integrated with an ingestible event marker, according to the following equation;

Y=A H;

wherein Y represents a matrix of observations of therapeutic and wellness data, A represents a matrix of dose event data, and H represents a response matrix.

38. The method of claim 37, wherein the therapeutic and wellness data includes ingestible event marker data received from the ingestible event marker integrated with the substance, the method comprising receiving a signal generated by the ingestible event marker when the substance is ingested.

39. The method of claim 37, comprising representing the dose events matrix A as a number of times when an ingestible event marker signaled that a dose was taken.

40. The method of claim 39, comprising representing the dose events of the matrix A as real time values of when the doses are taken.

41. The method of claim 40, comprising representing the real time values as actual time values of when the doses are taken.

44. The method of claim 37, wherein the therapeutic and wellness data includes data representative of physiological aspects associated with the ingestion of the ingestible event marker and the substance.

45. The method of claim 37, 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.

46. The method of claim 37, comprising controlling, by a therapy controller coupled to the processor and the at least one memory, at least one of an amount the substance and a time of the substance is ingested based on the response matrix H.

47. A method comprising:

receiving, by a processor and at least one memory coupled to the processor, dose event data A;

receiving, by the processor and the at least one memory, observations of therapeutic and wellness data Y; and

determining, by the processor and the at least one memory, based on the received observations of therapeutic and wellness data and the received dose event data, a response H representing a reaction to a substance integrated with an ingestible event marker, according to the following equation;

Y=A H;

wherein Y represents a matrix of observations of therapeutic and wellness data, A represents a matrix of dose event data, and H represents a response matrix; and

controlling, by a therapy controller coupled to the processor and the at least one memory, at least one of a dose of the substance and a time of the dose of the substance based on the response data and the therapeutic and wellness data.

42. The method of claim 49, comprising representing the dose events of the matrix A as binary values of when the doses are taken.

43. The method of claim 42, comprising representing no detection of a dosing event as a first binary value and representing detection of a dosing event as a second binary value.

48. The method of claim 47, comprising controlling, by the therapy controller, at least one of the dose of the substance and the time of the dose of the substance using a closed-loop.

49. The method of claim 47, comprising:

varying, by the therapy controller, an input to the response; and

generating an output of the response using a closed-loop, the output corresponding to at least one of the dose of the substance and the time of the dose of the substance.

50. The method of claim 47, comprising receiving, by the processor and the at least memory coupled to the processor, the ingestible event marker data from the ingestible event marker integrated with the substance, the ingestible event marker providing a signal when the substance is ingested.

51. The method of claim 47, comprising representing, by the processor and the at least memory coupled to the processor, the therapeutic and wellness data as physiological aspects associated with the ingestion of the ingestible event marker and the substance.

52. The method of claim 47, comprising determining, by the processor and the at least memory coupled to the processor, the response data based on the reaction of at least one of an individual patient, a population, and a subset of the population.