JP2020510899A - 薬物モニタリングツール - Google Patents
薬物モニタリングツール Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
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- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
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- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
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- C—CHEMISTRY; METALLURGY
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- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
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- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
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- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
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- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
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- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
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- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
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- H04L9/06—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols the encryption apparatus using shift registers or memories for block-wise or stream coding, e.g. DES systems or RC4; Hash functions; Pseudorandom sequence generators
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Abstract
Description
それぞれのゾーンは、患者内の治療的血漿タンパク質の時間変化量の特定の濃度範囲に関連付けられ得る。
次いで320において、方法300は、上の表1からの情報を使用してQRコードを生成する。方法300はAES−256暗号化を使用して暗号ブロック連鎖(CBC)及び公開鍵暗号標準(PKCS)パディングで暗号化された患者情報を有するためにQRコードを生成することができる。
Claims (21)
- 患者の薬物動態学的(PK)プロファイルを受信するように構成されているデータ受信機と、
前記患者の時間変化する治療的血漿タンパク質レベルを前記患者に表示するように構成されている対話的なユーザインターフェースであって、前記時間変化する治療的血漿タンパク質レベルが、凝固因子VIIIの投与された用量及び前記患者の前記PKプロファイルに基づいている、対話的なユーザインターフェースと、
を備える、薬物モニタリングツール。 - 前記患者の前記PKプロファイルが、サンプリングされた患者のPKプロファイルのベイズモデルに基づいており、且つ、前記患者の体重、フォン・ウィルブランド因子(「vWF」)レベル、及び/又は年齢のうちの少なくとも1つに基づく、請求項1に記載の薬物モニタリングツール。
- 前記データ受信機が、少なくともPKプロファイル情報を含む患者情報を記憶するキューアール(QR)コードをスキャンするように構成されているカメラであり、
前記薬物モニタリングツールが、前記QRコードに記憶された前記患者情報を抽出するとともに処理するように構成されているQRコードプロセッサをさらに備える、請求項1に記載の薬物モニタリングツール。 - 前記データ受信機が、セキュアサーバから前記PKプロファイルを受信するように構成されている通信インターフェースであって、前記受信されたPKプロファイルが暗号化され、
前記通信インターフェースが前記暗号化されたPKプロファイルを復号化するようにさらに構成されている、請求項1に記載の薬物モニタリングツール。 - AES−256暗号化を使用して暗号ブロック連鎖(CBC)及び公開鍵暗号標準(PKCS)パディングで暗号化された患者情報を有する前記QRコードを生成するように構成されているQRコード生成器をさらに備える、請求項3に記載の薬物モニタリングツール。
- 前記QRコード生成器が、前記薬物モニタリングツールから離れたセキュアサーバに配置される、請求項5に記載の薬物モニタリングツール。
- 前記QRコードが、患者特定情報、患者生理学的データ、患者投与情報、及び/又は前記患者のPKプロファイル情報、のうちの少なくとも1つ、又はそのあらゆる組み合わせを含み、前記患者投与情報が、特定の凝固因子VIII薬物についての予防的投与レジメンを含む、請求項3に記載の薬物モニタリングツール。
- 前記患者の前記PKプロファイルを受信すること、及び/又は最初の予防的な注射のログを受信すること、のうちの少なくともに応答して前記薬物モニタリングツールの機能群にアクセスできるように構成されているアクティブ化ツールキットをさらに備える、請求項1に記載の薬物モニタリングツール。
- 前記対話的なユーザインターフェースが、あらゆる所与の時間における前記患者内の前記治療的血漿タンパク質の時間変化量の図形表示を表示するように構成されており、前記図形表示が、前記治療的血漿タンパク質の前記時間変化量に関連付けられるゾーンの輪郭を描いており、それぞれのゾーンが、前記患者内の前記治療的血漿タンパク質の前記時間変化量の特定の濃度範囲に関連付けられる、請求項1に記載の薬物モニタリングツール。
- 前記対話的なユーザインターフェースが、特定の時間における前記患者内の前記治療的血漿タンパク質の前記時間変化量についての要求に対応する患者の入力を受信するように構成されている図的な制御要素を含み、前記対話的なユーザインターフェースが、前記特定の時間における前記患者内の前記治療的血漿タンパク質の前記時間変化量の前記図形表示を表示するように構成されている、請求項9に記載の薬物モニタリングツール。
- 患者の薬物動態学的(PK)プロファイルを受信するように構成されているデータ受信機と、
前記患者内の時間変化する薬物濃度レベルを患者に提示するように構成されている対話的なユーザインターフェースであって、前記時間変化する薬物濃度レベルが、対象薬物の投与された用量及び前記患者の前記PKプロファイルに基づいている、対話的なユーザインターフェースと、
を備える、薬物モニタリングツール。 - 薬物モニタリングツールによって実行される、薬物モニタリングする方法であって、
患者の薬物動態学的(PK)プロファイルを受信するステップと
前記患者の時間変化する治療的血漿タンパク質レベルを患者に表示することを対話的なユーザインターフェースにさせるステップであって、前記時間変化する治療的血漿タンパク質レベルが、凝固因子VIIIの投与された用量及び前記患者の前記PKプロファイルに基づいている、ステップと、
を含む、薬物モニタリングする方法。 - 前記患者の前記PKプロファイルが、サンプリングされた患者のPKプロファイルのベイズモデルに基づいており、且つ、患者の体重、フォン・ウィルブランド因子(「vWF」)レベル、及び/又は年齢のうちの少なくとも1つに基づく、請求項12に記載の方法。
- 前記PKプロファイルを受信するステップが、少なくともPKプロファイル情報を含む患者情報を記憶するキューアール(QR)コードをスキャンするステップと、
前記QRコードに記憶された前記患者情報を抽出するとともに処理するステップと、
を含む、請求項12に記載の方法。 - セキュアサーバから前記PKプロファイルを受信するステップであって、前記受信されたPKプロファイルが暗号化される、受信するステップと、前記暗号化されたPKプロファイルを復号化するステップと、
をさらに含む、請求項12に記載の方法。 - AES−256暗号化を使用して暗号ブロック連鎖(CBC)及び公開鍵暗号標準(PKCS)パディングで暗号化された患者情報を有する前記QRコードを生成するステップをさらに備える、請求項14に記載の方法。
- 前記QRコードが、患者特定情報、患者生理学的データ、患者投与情報、及び/又は前記患者のPKプロファイル情報、のうちの少なくとも1つ、又はそのあらゆる組み合わせを含み、前記患者投与情報が特定の凝固因子VIII薬物についての予防的投与レジメンを含む、請求項14に記載の方法。
- 患者が、前記患者の前記PKプロファイルを受信すること、及び/又は最初の予防的な注射のログを受信すること、のうちの少なくともに応答して前記薬物モニタリングツールの機能群にアクセスできるようにするステップをさらに含む、請求項12に記載の方法。
- あらゆる所与の時間における前記患者内の前記治療的血漿タンパク質の時間変化量の図形表示を表示するステップであって、前記図形表示が、前記治療的血漿タンパク質の前記時間変化量に関連付けられるゾーンの輪郭を描いており、それぞれのゾーンが、前記患者内の前記治療的血漿タンパク質の前記時間変化量の特定の濃度範囲に関連付けられる、ステップをさらに含む、請求項12に記載の方法。
- 特定の時間における前記患者内の前記治療的血漿タンパク質の前記時間変化量についての要求に対応する患者の入力を受信するように構成されている図的な制御要素を用意するステップと、
前記特定の時間における前記患者内の前記治療的血漿タンパク質の前記時間変化量の前記図形表示を表示するステップと、
をさらに含む、請求項19に記載の方法。 - 治療的血漿タンパク質投与レジメン装置と、薬物モニタリングツールと、を備える薬物モニタリングシステムであって、
前記治療的血漿タンパク質投与レジメン装置は、
サンプリングされた患者の薬物動態学的(PK)プロファイルのベイズモデルを作成するモデル生成器であり、
前記ベイズモデルが(i)治療的血漿タンパク質のクリアランス、及び(ii)患者の年齢又は体重のうちの少なくとも1つに基づく治療的血漿タンパク質についての分布容積関連性、を含む、モデル生成器と、
PKサーバであり、
前記ベイズモデル、前記患者内の前記治療的血漿タンパク質の半減期、及び前記患者の年齢又は前記患者の体重のうちの少なくとも1つ、に基づいて患者の近似のPKプロファイルを決定することと、
前記患者の前記近似のPKプロファイルに基づき時間期間を通しての用量及び治療的血漿タンパク質レベルを含む前記治療的血漿タンパク質投与レジメンを決定することと、
前記患者に用量を適用するための投与間隔を受信することに応答して前記治療的血漿タンパク質投与レジメンを修正することと、
前記修正された治療的血漿タンパク質投与レジメンをクライアントデバイスに送信することと、
を行うように構成されている、PKサーバと、
を含み、
前記薬物モニタリングツールは、
患者の前記薬物動態学的(PK)プロファイルを受信するように構成されているデータ受信機と、
前記患者の時間変化する治療的血漿タンパク質レベルを前記患者に表示するように構成されている対話的なユーザインターフェースであり、前記時間変化する治療的血漿タンパク質レベルが、凝固因子VIIIの投与された用量及び前記患者の前記PKプロファイルに基づいている、対話的なユーザインターフェースと、
を含む、薬物モニタリングシステム。
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