Laboratory analysis decision-making

Within the pharmaceutical industry we have progressed from the point where computers in the laboratory were rarely present or used beyond spreadsheet calculations. Now computers are ubiquitous in pharmaceutical research and development laboratories, and nearly everyone has at least one used in some way to aid in his or her role. It should come as no surprise that the development of hardware and software over the last 30 years has expanded the scope of computer use to virtually all stages of pharmaceutical research and development (data analysis, data capture, monitoring and decision making). Although there are many excellent books published that are focused on in-depth discussions of computer-aided drug design, bioinformatics, or other related individual topics, none has addressed this broader utilization of... 

Laboratory analysis provides data that will be used as the basis for decision-making. The data require that the analysis of samples in laboratories meets specific quality assurance and quality control (QA/QC) requirements. 

QA splits are particularly valuable for field screening with definitive analysis confirmation and for the verification of field laboratory analysis. The frequency of the QA sample collection is best determined based on the project duration and the total numbers of samples to be collected. Typically, they are collected at a 10 percent frequency (one QA sample for every 10 field samples). It is beneficial to establish data comparability in the early phase of field implementation. If data are comparable, the frequency of QA sampling may be reduced as the confidence in field screening or field laboratory results has been established. But if the data are not comparable, the project team needs to identify the cause of the differences and resolve them as soon as possible in order to avoid making decisions on inaccurate or unrepresentative data. 

Although the direct medical costs of anemia are unknown, the direct costs of drug treatment must be weighed with the indirect costs associated with anemia. The costs of laboratory tests used to diagnose anemia, the role of screening for anemia, and the prevention of anemia are aU components that necessitate consideration in the phar-macoeconomic analysis. Anemia practice guidelines within medical subspecialties must take pharmacoeconomics into consideration as they are developed. Additionally, the frequency of blood transfusions must be considered, as it impacts cost and therapeutic decision making in patients. 

Analysis performed in the field is faster and more economical than analysis done in a laboratory. As analytical techniques are constantly improving and lighter and more portable equipment is being developed, more analytical work can be carried out directly in the field. Test methods are now available for measuring physical properties of oil such as viscosity, density, and even flash point in the field. Test kits have also been developed that can measure total petroleum hydrocarbons directly in the field. While these test kits are less accurate than laboratory methods, they are a rapid screening tool that minimizes laboratory analysis and may provide adequate data for making response decisions. 

Benefits of POC technology include the lower costs of out-patient versus in-patient care, savings in both waiting time and consultation time in clinics, savings in laboratory analysis time and effort, the fact that it is often less invasive than hospital testing and that POC devices are more readily available to the public. Importantly, too, POC devices allow doctors to make decisions quickly based on the rapidly available results. Reimbursement from insurance providers is now possible for some POC devices, such as home glucose... 

Bare, J.C., 2002. Developing a Consistent Decision-making Framework by Using the U.S. EPA s TRACI Systems Analysis Branch, Sustainable Technology Division, National Risk Management Research Laboratory. US Environmental Protection Agency, Cincinnati, OH. 

The first is the web page of the international Society on Multiple Criteria Decision Making. It has links to MCDM software and a bibliography. Most of the software is available free for research and teaching use. The second link is to the Systems Analysis Laboratory at Aalto University. It also has links to some free software, again for research and instructional use. 

An Instrument Control Language (ICL ) gives both power and flexihihty in operating the system. With this operators have complete control to create or customize instrument procedures, and design experiments to exactly meet laboratory needs. TTie instrument can optimize analysis by making real-time decisions during data acquisitions. 

Given estimates of both the real cost of bringing LIMS technology into the laboratory, and the dollar value benefits to be accrued from it, there only remains to make a final comparison. Since costs and benefits are not necessarily experienced in the same time frames, the financial analysis methods by which the firm makes capital investment decisions must be used. The LIMS which appears to be desirable from a technical and operational viewpoint must be proven to be a productivity or revenue improving capital investment and not just another overhead expense item. 

---