DiCarlo L.A.,Proteus Biomedical, Inc.
Contemporary Clinical Trials | Year: 2012
Identifying a dosing regimen for recommended use is one of the more difficult tasks in pharmaceutical development and has major therapeutic and economic consequences. In the clinical phase of pharmaceutical development, pharmacokinetic-pharmacodynamic (PK/PD) models are used to characterize the relationship between drug exposure and clinical outcome. When adherence to the prescribed drug dosage is known, true dose-response can be validly estimated, while non-compliance with the nominal prescribed dosage causes unintended variability in actual drug exposure and ensuing difficulty in determining dose-response. The purpose of this manuscript is to provide an overview of the important role that adherence plays in the interpretation of clinical studies for pharmaceutical development, to summarize the challenges in utilizing currently available tools for assessing adherence, to characterize the attributes of an ideal adherence marker, and to describe the utilization of a networked system having an ingestible sensor for direct confirmation of pharmaceutical utilization in drug development studies. The positive detection accuracy of this networked system when compared to direct ingestion is 99.3% [95%CI: 0.977, 0.999]. A direct measure of pharmaceutical utilization in pharmaceutical studies provides the means to examine the temporal patterns of drug response that are engendered by patients' actual dosing patterns, and to characterize more accurately exposure-response relationships. Materials and methods are available to accomplish these goals. © 2012 Elsevier Inc.
Proteus Biomedical, Inc. | Date: 2015-01-22
Power sources that enable in-body devices, such as implantable and ingestible devices, are provided. Aspects of the in-body power sources of the invention include a solid support, a first high surface area electrode and a second electrode. Embodiments of the in-power sources are configured to emit a detectable signal upon contact with a target physiological site. Also provided are methods of making and using the power sources of the invention.
Proteus Biomedical, Inc. | Date: 2015-04-29
An apparatus that includes a partial power source including a first material and a second material, the partial power source configured to generate, upon contact with a conducting medium, a potential difference between the first material and the second material to provide power to a control device, and generate, using the first material and the second material, a current flow within the conducting medium, the current flow including information encoded based on a variable conductance between the first material and the second material.
Proteus Biomedical, Inc. | Date: 2015-06-10
The invention provides a receiver associated with a body, e.g., located inside or within close proximity to a body, configured to receive and decode a signal from an in vivo transmitter which located inside the body. Signal receivers of the invention provide for accurate signal decoding of a low-level signal, even in the presence of significant noise, using a small-scale chip, e.g., where the chip consumes very low power. Also provided are systems that include the receivers, as well as methods of using the same.
Proteus Biomedical, Inc. | Date: 2014-07-25
Aspects of the invention include multi-mode communication ingestible event marker devices. Ingestible event marker devices of the invention include an ingestible component comprising a conductive communication module and at least one additional non-conductive communication module. The non-conductive communication module may be integrated with the ingestible component or at least a portion or all of the non-conductive communication module may be associated with a packaging component of the ingestible event marker device. Additional aspects of the invention include systems that include the devices and one or more receivers, as well as methods of using the same.