Packaging performance data

Lion Biosciences is the supplier of the iDEA Metabolism software package as well as other ADME/T services (289). The iDEA software simulates metabolism and predicts a compound s metabolic behavior in humans. The Metabolism Module consists of a data expert module to perform data fitting and analysis of collected in vitro data and the physiological metabolism model. The physiological metabolism model is constructed from proprietary database of 64 clinically tested compounds. Additionally, the metabolism module automatically calculates the Michaelis-Menten constants Km and VjIiax for the kinetic analysis of metabolism turnover (289). 

A stepwise approach to DQA identifies different tasks that may be performed by individuals with different expertise. For example, a less experienced chemist may verify the data package content (Step 2), whereas a more experienced chemist may perform data evaluation (Step 3). For a statistical data collection design, a statistician may be involved in the assessment of data relevancy (Step 6). A database manager may be involved at several steps if the EDDs are part of laboratory deliverables and if completeness is calculated. 

A lot of software products are available in order to perform data acquisition and/or data manipulation. Most of the packages are specific to the interface card used and most of them are only a collection of subroutines which allow to control the specific hardware. 

Before discussing some applications, a few basic aspects on univariate statistics will be presented. A large amount of information exists regarding this field, and more details can be found in the original literature (e.g. [70,71]). Also a variety of computer packages performing statistical data analysis is available (e.g. [71a]). 

There have been signihcant advances to harvest the power of the mass spectrometry-based analysis technique. The ability to perform real-time scanning experiments with real-hme automated dynamic feedback has become an essenhal component of qualitahve analysis, such as biotransformahon or proteomics applicahons. Most commercial mass spectrometry software packages provide the ability to perform data-dependent scanning procedures. Metabolic prohling and proteomics generate large quanhties of data that must be quickly and efficiently interpreted and hltered such that the data can be quickly reported in a way that will support rapid decisions. 

Some pharmacokinetic software packages perform noncompartmental analysis without fitting the entire response curve. These programs compute the elimination rate constant (k) for the terminal elimination phase of the data, and then use a trapezoidal rule with this elimination rate constant to compute AUC and AUMC. With these terms, the total body clearance, the steady-state volume of distribution, and the mean residence time in the body can be calculated. Without C , it is not possible to calculate the volume of distribution of the central compartment or the mean residence time of the sampling compartment. The latter term is therefore critical in accurately determining these parameter values and depends on an unbiased and close fit of the data to Equations 13.2 and 13.6. 

To enable this, technology suppliers may provide appropriate database software tailored to their hardware designs. Such packages normally provide for recording both assembly and maintenance information and performance data (Section 13.11). 

In some businesses, safety performance data and records help gain a competitive advantage. Investors and business collaborators may consider safety performance as one factor in reaching business decisions with a potential supplier. Some government contracting procedures require bidders to include safety performance data as part of a bid package. A bidding company may not qualify at all if safety performance falls below some standard. Final selection and contract... 

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