Pharmaceuticals modem development

Tire total spectirim of concepts, processes and technologies of biotechnology, chemistry and electronics is being applied in modem industrial pharmaceutical research, development and prodnction. 

The pharmaceutical reference substance system, accepted in USSR, did not meet to modern requirements. For creation of a modem system in Ukraine it was required to develop criteria to uncertainty of analytical phamiaceutical procedures. 

During the twentieth century chemistry changed for ever the way we live. Perhaps the greatest perceived benefits, to the general public, have come from the pharmaceuticals industry with developments of painkillers, antibiotics, heart drugs and, more recently, Viagra. However, it is difficult to think of an important facet of modem life which has not been transformed by products of the chemical and related industries, for example ... 

The coordination of this entire complex process is the province of project management, the objective of which is to ensure that all the necessary parts and components of a project mate up. This discipline in its modem form was first developed for the Polaris missile project in the 1960s. Its major tool that is familiar to pharmaceutical scientists is the network or PERT (Program Evaluation Review Technique) chart, as illustrated in Figure 1.2. This chart is a tool that allows one to see and coordinate the relationships between the different components of a project. One outcome of the development of such a network is identification of the rate-limiting steps, which, in aggregate, comprise the critical path (see Table 1.3 for a lexicon of the terms used in project management). 

In the current, price-sensitive environment, which is the hallmark of modem healthcare and certainly new drug development, expenses necessary to support clinical research are a major concern for sponsors. Both fixed and variable costs can be managed effectively compared to complete in-house development budgets. As product development costs are a significant element influencing pharmaceutical pricing, the role of innovative CROs is expected to grow. 

Grossman, S.J., Overview drug metabolism in the modem pharmaceutical industry. In Drug Metabolism in Drug Design and Development, Zhang, D., Zhu, M. and Humphreys, W.G. (eds). J. Wiley Sons, Inc., 2008, pp. 3-13. 

The development of a plethora of HPLC CSPs in the 1980s and 1990s has, to a large extent, made the use of chiral mobile-phase additives (CMPAs) redundant in most modem pharmaceutical analytical laboratories [23]. Before this period, chiral selectors were used routinely as additives in HPLC, but are now only used for a small number of specific applications [23]. CMPAs are used to form... 

Apart from natural-product-derived modem medicine, natural products are also used directly in the natural pharmaceutical industry that is growing rapidly in Europe and North America, as well as in the traditional medicine programmes being incorporated into the primary health care systems of Mexico, The People s Repuhhc of China, Nigeria and other developing countries. 

Currently, high-performance liquid chromatography (HPLC) combined with atmospheric pressure ionization (API) triple-quadrupole mass spectrometry (MS) is the predominate quantitative technique used in modem pharmaceutical bioanalysis. The key technological achievement in API-MS was the efficient ionization in a liquid stream and transference of ions from atmosphere to vacuum. Of the API approaches developed, electrospray ionization (ESI) is the most commonly used. ESI provides an efficient means of soft ionization amenable to most molecules encountered in a dmg discovery setting. An alternative soft ionization approach is the use of desorption ionization (DI) techniques. The major distinguishing feature of DI techniques is that ions are typically produced from dried samples. 

Although now essentially obsolete for the treatment of human diseases because of their toxicities, organoarsenic compounds were the first synthetic organic pharmaceutical agents and were widely used in the early 1900s. The first pharmaceutical application was that of atoxyl (the sodium salt of 4-aminophenylarsinic acid), which was used to treat sleeping sickness. The synthesis of Salvarsan by Dr. Paul Ehrlich in 1907 was a development that may be considered the beginning of modem chemotherapy (chemical treatment of disease). Salvarsan was widely used for the treatment of syphilis. Toxic effects of Salvarsan included jaundice and encephalitis (brain inflammation). 

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