Pharmaceutical industry cost-effectiveness

In the pharmaceutical industry, it is essential to produce pure drug substance, suitable for human consumption, in a cost-effective manner. The purity of a drug substance can be checked by separation techniques such as GC, TLC, and HPLC. Both techniques tend to be more sensitive and specific than spectroscopic methods. HPLC has an advantage over GC as an analytical technique, since analytes need be neither volatile nor extremely stable to elevated temperatures. Highly accurate, almost universal detectors, such as... 

The ability to efficiently synthesize enantiomerically enriched materials is of key importance to the pharmaceutical, flavor and fragrance, animal health, agrochemicals, and functional materials industries [1]. An enantiomeric catalytic approach potentially offers a cost-effective and environmentally responsible solution, and the assessment of chiral technologies applied to date shows enantioselective hydrogenation to be one of the most industrially applicable [2]. This is not least due to the ability to systematically modify chiral ligands, within an appropriate catalyst system, to obtain the desired reactivity and selectivity. With respect to this, phosphorus(III)-based ligands have proven to be the most effective. 

Hyphenated analytical techniques such as LC-MS, which combines liquid chromatography and mass spectrometry, are well-developed laboratory tools that are widely used in the pharmaceutical industry. Eor some compounds, mass spectrometry alone is insufficient for complete structural elucidation of unknown compounds nuclear magnetic resonance spectroscopy (NMR) can help elucidate the structure of these compounds (see Chapter 20). Traditionally, NMR experiments are performed on more or less pure samples, in which the signals of a single component dominate. Therefore, the structural analysis of individual components of complex mixtures is normally time-consuming and less cost-effective. The... 

Some of the industrial challenges for the adoption of PAT in the pharmaceutical industry are how to implement this on existing products, where the investment of manufacturing equipment has already been made, and the motivation to improve the process (or perhaps even to better understand it) may not be deemed cost-effective (though there is a potential of both improving product quality and reducing manufacturing costs). 

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

Griffin JR/s therapeutic conservatism cost effective prescribing European Federation of Pharmaceutical Industries Associations, General Assembly 1993 3rd session Health Objectives and Cost Control. 

Pll The asymmetric synthesis of a-amino acids and derivatives is an important topic as a result of their extensive use in pharmaceuticals and agrochemicals and as chiral ligands. Many highly enantioselective approaches have been reported. Industrial production of a-amino acids via the Strecker reaction is historically one of the most versatile methods to obtain these compounds in a cost-effective manner, making use of inexpensive and easily accessible starting materials. (From Boesten et al., 2001)... 

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