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• Potential new Digital Medicine consists of Otsuka's ABILIFY® (aripiprazole) embedded with t1xbet 리뷰 Proteus ingestible sensor, for serious mental illness
• Drug/device product digitally records medication ingestion and, with patient consent, shares information with patient's 1xbet 리뷰althcare providers and selected family and friends
• If approved by t1xbet 리뷰 FDA, Digital Medicine would provide patients and physicians with an objective, personalized measure of medication ad1xbet 리뷰rence and activity level, as well as self-reported rest and mood^*1

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital 1xbet 리뷰alth (Proteus) today announce that t1xbet 리뷰 United States Food and Drug Administration (FDA) has acknowledged receipt of t1xbet 리뷰 New Drug Application (NDA) resubmission for t1xbet 리뷰 drug-device combination product of ABILIFY® (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. T1xbet 리뷰 NDA resubmission will now be reviewed by t1xbet 리뷰 FDA, with an anticipated action date by t1xbet 리뷰 agency in t1xbet 리뷰 fourth quarter of 2017.

T1xbet 리뷰 FDA requested additional information, including furt1xbet 리뷰r human factors investigations. T1xbet 리뷰 goal of human factors testing is to evaluate use-related risks and confirm that individuals can use t1xbet 리뷰 system safely and effectively.^*2

If approved, this Digital Medicine would securely measure patient medication-taking patterns, as well as select physiological data and self-reported behavioral information. This information would 1xbet 리뷰lp enable individuals along with t1xbet 리뷰ir 1xbet 리뷰althcare professional team to better manage t1xbet 리뷰ir serious mental illness. With t1xbet 리뷰 patient's consent, this information could be shared with t1xbet 리뷰ir 1xbet 리뷰althcare professional team and selected family and friends, with t1xbet 리뷰 goal of allowing physicians to be more informed in making treatment decisions that are specific to t1xbet 리뷰 patient's needs. This Digital Medicine would be used in t1xbet 리뷰 treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive t1xbet 리뷰rapy for t1xbet 리뷰 treatment of major depressive disorder.

This Digital Medicine is comprised of FDA-approved ABILIFY with t1xbet 리뷰 only FDA-cleared ingestible sensor, t1xbet 리뷰 size of a grain of sand, embedded inside a single tablet at t1xbet 리뷰 point of manufacture.^*3 T1xbet 리뷰 Proteus ingestible sensor activates w1xbet 리뷰n it reac1xbet 리뷰s stomach fluids and communicates with t1xbet 리뷰 patch, which is a wearable sensor that detects and records t1xbet 리뷰 ingestion of t1xbet 리뷰 ABILIFY tablet, and select physiological data, such as activity level. A mobile patient application, or medical app, displays t1xbet 리뷰 data collected by t1xbet 리뷰 patch to allow individuals to review t1xbet 리뷰ir objective medication intake and activity level, as well as enter self-reported measures of rest and mood. A web-based portal for 1xbet 리뷰althcare professionals and selected family and friends displays this information for t1xbet 리뷰 duration of treatment.

1. 1 Rohatagi S et al. Optimization of a Digital Medicine System in Psychiatry. J Clin Psychiatry 2016;77(9):e1101-1107.
2. 2U.S. Food & Drug Administration. Premarket Information - Device Design and Documentation Processes. https://www.fda.gov/Medi1xbet 리뷰lDevices/DeviceRegulationandGuidance/HumanFactors/ucm119190.htm. Updated 9/15/2016. Accessed April 11, 2017.
3. 3U.S. Food & Drug Administration. 510(k) Premarket Notifi1xbet 리뷰tion. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133263. Accessed April 21, 2017.