Pharmaceutical industry monitoring

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... 

The ideal interface is rare. Table 7.3 lists the qualities required for an ideal interface from a chromatographic point of view [3]. Nowadays, hyphenation goes a long way towards total analysis systems (e.g. HPLC-UV-NMR-MS), especially in the pharmaceutical industry. Such magic-wand systems are by no means a panacea for all analytical problems they are more likely to be confined to niche applications. Multihyphenation and multidetector monitoring set their own... 

Although this book focuses on high-throughput analyses in the pharmaceutical industry, applications in environmental analysis are closely related. The same technologies are applicable to both fields. Pharmaceuticals have been monitored as pollutants in surface water, soil, food, and human plasma. In environmental applications, as many as 30 to 40 analytes have been monitored simultaneously. 

Safety evaluation does not cease being an essential element in the success of the pharmaceutical industry once a product is on the market. It is also essential to support marketed products and ensure that their use is not only effective but also safe and unclouded by unfounded perceptions of safety problems. This requires not only that clinical trials be monitored during development (Spector et al., 1988), but also that experience in the marketplace be monitored. 

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

IR is one of three forms of vibrational spectroscopy that is in conunon use for process analytical measurements the other two being near-lR (NIR) and Raman. Each one of these techniques has its pros and cons and the ultimate selection is based on a number of factors ranging from sample type, information required, cost and ease of implementation. The sample matrix is often a key deciding factor. NIR has been the method of choice for many years within the pharmaceutical industry, and sample handling has been the issue, especially where solid products are involved. IR is not particularly easy to implement for the continuous monitoring of solid substrates. However, often there is no one correct answer, but often when the full application is taken into account the selection becomes more obvious. In some cases very obvious, such as the selection of IR for trace gas analysis - neither NIR nor Raman is appropriate for such applications. 

M.A. Bernstein, M. Steflnovic, and C. J. Sleigh, Optimising reaction performance in the pharmaceutical industry by monitoring with NMR, Magn. Reson. Chem., 45, 564-571 (2007). 

While LIF monitoring is established in other manufacturing industries, it is relatively new within the pharmaceutical industry. The application of real-time intrinsic LIF for the manufacture of pharmaceuticals in general can be broken in to three areas (i) classic (small molecule) final drug product manufacturing (ii) biopharmaceutical prodnct manufacturing and (iii) factory operational applications. 

Examples of terahertz spectroscopy as a PAT tool in the pharmaceutical industry include monitoring of polymorphism, tablet coatings, and crystallinity, even at the stage of product development to aid in process design. ... 

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