Abstract: Embodiments in accordance with the present invention relate to a platform facilitating different drug development software programs. In one embodiment, the integrated software platform includes a graphical environment for creating, storing, and manipulating workflows. The workflows depict operations that are to be performed by certain functional objects, and the flow of information between those objects. One example of an object is a model of drug behavior, disposition, and/or physiological response to drug activity, and certain embodiments allow for the graphical creation and editing of such a model. Other embodiments provide a user with the ability to easily overlay model predicted valves with observed data.

Abstract: Computer systems and methods facilitate exploring results of drug candidate modeling. In one embodiment, the software is configured to receive raw data simulated by a probabilistic model of clinical safety, tolerability, and efficacy of a drug candidate. Index information is extracted from the raw data and then referenced to generate a metadata file, the structure of the metadata file,explicitly reflecting a hierarchical structure of the model. The metadata file is in turn used to convert the raw data into a binary file, the metadata file explicitly identifying locations within the binary file, of treatment scenario information types and output performance information types. The metadata file is also referenced to generate an interface configured to receive inputs from a non-expert audience, and in turn present relevant subsets of the binary file in a limited number of plot and tabular formats.

Abstract: Systems and methods are disclosed for identifying and/or compensating for relationships between influencers and outcomes. First, a metadata model of information that characterizes relationships between influencers and outcomes is built. A query is accepted from a user, and an outcome of interest is determined based on the query. The model is subsequently relied on to flag influencers that might have an impact on an outcome of interest. The impact of these influencers on the outcome of interest is then analyzed with respect to specific conditions. When the impact is sufficiently large, the user is notified or an adjustment is made to the user's query.

Abstract: A method for interactively constructing pharmacological computational models is disclosed. A graphical user interface is presented through which a user may place and connect objects representing pharmacokinetic and pharmacodynamic elements. As the objects are placed and connected, they are converted into an internal format representing the statements of the corresponding computational model. These statements are actively presented to the user in a summarized form, as the computational model is constructed, to enable immediate verification of the model. This summarized form may be a surface syntax showing key equations that make up the model, or they may be graphs of behavior of one or more user-selected variables.

Abstract: A system and method for simulating clinical trial protocols with compiled state machines is presented. The system receives input data representing a clinical trial protocol. This information is sorted into a plurality of schedules, including dosage schedules, observation schedules, and various other types of schedules. The schedules are translated into a general purpose high level programming language and then compiled into and executable file. The executable file may comprise a plurality of discrete state machines, each state machine corresponding directly to a single schedule. During the clinical trial simulation, the executable file is run by the trial simulator to simulate the trial protocol.

Abstract: A method for maintaining consistent unit relationships during graphical pharmacological computational model construction is disclosed. A graphical user interface is presented through which a user may place and connect objects representing pharmacokinetic and pharmacodynamic elements. The user may specify units definitions for variables and constants using unit expressions. As the objects are converted into an internal format representing the statements of the corresponding computational model, the unit expressions are included in this internal format as multidimensional data type information. This multidimensional data type information is regularly and automatically propagated for each statement in the internal format to identify inconsistent units. When such inconsistent units are identified, a warning message is generated to notify the user, substantially immediately after the inconsistent units are created.

Abstract: Computer systems and methods facilitate exploring results of drug candidate modeling. In one embodiment, the software is configured to receive raw data simulated by a probabilistic model of clinical safety, tolerability, and efficacy of a drug candidate. Index information is extracted from the raw data and then referenced to generate a metadata file, the structure of the metadata file explicitly reflecting a hierarchical structure of the model. The metadata file is in turn used to convert the raw data into a binary file, the metadata file explicitly identifying locations within the binary file, of treatment scenario information types and output performance information types. The metadata file is also referenced to generate an interface configured to receive inputs from a non-expert audience, and in turn present relevant subsets of the binary file in a limited number of plot and tabular formats.

Abstract: Methods of performing temporal logic queries, and systems for performing temporal logic queries, are disclosed. Data associated with statistical reliability criteria are annotated in a data source. Baseline data stored in the data source is summarized. Temporal data requests made upon the data source are automatically merged with the data associated with the statistical reliability criteria, to produce a statistically valid data query. Data query results are optionally provided to a statistics module for processing of statistical analyses.

Abstract: The present invention is directed to a method and mechanism to selectively evaluate data items and search queries for privacy violations. According to an embodiment of the invention, attributes of a data item are identified and quantified to evaluate its potential to violate privacy interests. Search queries can be evaluated before accessing the records according to an embodiment, which improves operating efficiency and provides additional privacy protections. The query evaluation determines whether to disallow a query or withhold a query result if an individual or a small group of individuals can be identified by the results or if variables revealed will violate privacy policies. Also, the invention enables a provider of information to systematically evaluated the selectivity and visibility of attributes that are analyzed to allow or disallow queries and to set thresholds for different combinations of attributes.