A Personalized Medicine Approach Using Clinical Utility Index and Exposure‐Response Modeling Informed by Patient Preferences Data
Selection of a personalized dose for an individual patient can be informed by the patient’s preferences, translated as weights on each of the clinically relevant safety and efficacy drug attributes, based on results from a brief patient preference elicitation questionnaire. In this analysis, the wei...
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| Veröffentlicht in: | CPT: pharmacometrics and systems pharmacology 2021-01, Vol.10 (1), p.40-47 |
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| creator | Winzenborg, Insa Soliman, Ahmed M. Shebley, Mohamad |
| description | Selection of a personalized dose for an individual patient can be informed by the patient’s preferences, translated as weights on each of the clinically relevant safety and efficacy drug attributes, based on results from a brief patient preference elicitation questionnaire. In this analysis, the weighted attributes were simulated to represent various endometriosis patient profiles. Exposure‐response simulations were performed for elagolix, a drug approved for management of moderate to severe pain associated with endometriosis, across a range of plasma exposures corresponding to a range of doses. The results were combined to calculate a personalized clinical utility index. An interactive user‐friendly online application was developed and envisioned as a physician’s desk tool to personalize the dose selection process based on individual patient preferences. This demonstration should serve as an example of how patient/physician conversation can be facilitated with quantitative tools for personalizing the dose. |
| doi_str_mv | 10.1002/psp4.12570 |
| format | Article |
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In this analysis, the weighted attributes were simulated to represent various endometriosis patient profiles. Exposure‐response simulations were performed for elagolix, a drug approved for management of moderate to severe pain associated with endometriosis, across a range of plasma exposures corresponding to a range of doses. The results were combined to calculate a personalized clinical utility index. An interactive user‐friendly online application was developed and envisioned as a physician’s desk tool to personalize the dose selection process based on individual patient preferences. This demonstration should serve as an example of how patient/physician conversation can be facilitated with quantitative tools for personalizing the dose.</description><identifier>ISSN: 2163-8306</identifier><identifier>EISSN: 2163-8306</identifier><identifier>DOI: 10.1002/psp4.12570</identifier><identifier>PMID: 33200566</identifier><language>eng</language><publisher>United States: John Wiley & Sons, Inc</publisher><subject>Adolescent ; Adult ; Analgesics - administration & dosage ; Analgesics - blood ; Analgesics - pharmacokinetics ; Clinical trials ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase III as Topic ; Computer Simulation ; Dose-Response Relationship, Drug ; Drug dosages ; Endometriosis ; Endometriosis - complications ; Endometriosis - drug therapy ; Endometriosis - metabolism ; Experiments ; FDA approval ; Female ; Fractures ; Hot flash ; Humans ; Hydrocarbons, Fluorinated - administration & dosage ; Hydrocarbons, Fluorinated - blood ; Hydrocarbons, Fluorinated - pharmacokinetics ; Liver-Specific Organic Anion Transporter 1 - genetics ; Middle Aged ; Models, Biological ; Pain ; Pain - blood ; Pain - drug therapy ; Pain - etiology ; Patient Preference ; Patients ; Precision Medicine ; Pyrimidines - administration & dosage ; Pyrimidines - blood ; Pyrimidines - pharmacokinetics ; Simulation ; Surveys and Questionnaires ; Young Adult</subject><ispartof>CPT: pharmacometrics and systems pharmacology, 2021-01, Vol.10 (1), p.40-47</ispartof><rights>2020 AbbVie Inc. published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.</rights><rights>2020 AbbVie Inc. 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In this analysis, the weighted attributes were simulated to represent various endometriosis patient profiles. Exposure‐response simulations were performed for elagolix, a drug approved for management of moderate to severe pain associated with endometriosis, across a range of plasma exposures corresponding to a range of doses. The results were combined to calculate a personalized clinical utility index. An interactive user‐friendly online application was developed and envisioned as a physician’s desk tool to personalize the dose selection process based on individual patient preferences. This demonstration should serve as an example of how patient/physician conversation can be facilitated with quantitative tools for personalizing the dose.</abstract><cop>United States</cop><pub>John Wiley & Sons, Inc</pub><pmid>33200566</pmid><doi>10.1002/psp4.12570</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Analgesics - administration & dosage Analgesics - blood Analgesics - pharmacokinetics Clinical trials Clinical Trials, Phase I as Topic Clinical Trials, Phase III as Topic Computer Simulation Dose-Response Relationship, Drug Drug dosages Endometriosis Endometriosis - complications Endometriosis - drug therapy Endometriosis - metabolism Experiments FDA approval Female Fractures Hot flash Humans Hydrocarbons, Fluorinated - administration & dosage Hydrocarbons, Fluorinated - blood Hydrocarbons, Fluorinated - pharmacokinetics Liver-Specific Organic Anion Transporter 1 - genetics Middle Aged Models, Biological Pain Pain - blood Pain - drug therapy Pain - etiology Patient Preference Patients Precision Medicine Pyrimidines - administration & dosage Pyrimidines - blood Pyrimidines - pharmacokinetics Simulation Surveys and Questionnaires Young Adult |
| title | A Personalized Medicine Approach Using Clinical Utility Index and Exposure‐Response Modeling Informed by Patient Preferences Data |
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