Pharmaceutical sector environment

This means that Australia, Malaysia and Venezuela have to invest significant human and financial resources in inspections of the supply channels in their respective countries in order to ensure compliance with the requirements of good distribution practice (GDP) and the provisions of the pharmaceutical laws. Arranging human resources and schedules for inspection is even more arduous when the distribution outlets are widely dispersed through the rural areas. 

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Solubility modelling with activity coefficient methods is an under-utilized tool in the pharmaceutical sector. Within the last few years there have been several new developments that have increased the capabilities of these techniques. The NRTL-SAC model is a flexible new addition to the predictive armory and new software that facilitates local fitting of UNIFAC groups for Pharmaceutical molecules offers an interesting alternative. Quantum chemistry approaches like COSMO-RS [25] and COSMO-SAC [26] may allow realistic ab-initio calculations to be performed, although computational requirements are still restrictive in many corporate environments. Solubility modelling has an important role to play in the efficient development and fundamental understanding of pharmaceutical crystallization processes. The application of these methods to industrially relevant problems, and the development of new... 

Contract research, analysis and consultancy in the chemicals, environment, forensics, food, health, life sciences and pharmaceuticals sectors World-wide distribution of reference materials and standards following acquisition of the Promochem company. 

The driving force for the introduction of new processes are economic considerations, which are largely influenced by the production costs of the product and product quality. The optimal exploitation of raw materials, energy saving, and the environmental friendliness of processes will still take presidence in futnre. Selectivity is becoming more and more the decisive factor in industrial processes, mainly as a result of increasing purity demands, for example, in polymer chemistry and in the pharmaceutical sector. Higher selectivity means that better use is made of raw materials and therefore lower formation of side products, which must be removed in expensive separation processes or pollute the environment. 

The new Monsanto process makes use of a copper catalyst, which is used to reduce diethanolamine to DSIDA, the intermediate to Roundup (see Fig. 9.27). This process totally eliminates the use of ammonia, hydrogen cyanide, and formaldehyde, is free of contaminants and byproducts, and hence does not require further purification steps. The stream can be recycled after filtration of catalyst. Monsanto s process can also be used in the production of other amino acids such as glycine through reduction and is a general method for conversion of primary alcohols to carboxylic acid salts. The development of this technology for processes pertaining to the agricultural, commodity, specialty, and pharmaceutical sectors would have a pronounced impact on the environment. 

Europe s biotech and pharma sectors are compromised by healthcare cost containment and the inability to provide a uniform regulatory, political and financial system. However, the national govenunents individually and collectively are committed to strategic improvements to increase competitiveness. Japan is in a similar situation, but although its pharmaceutical sector has matured its biotech industry is in its infancy. Government action to improve the research environment has been slow. 

The pharmaceutical industry is precisely one of the sectors in which patents have most impact. The general arguments that are formulated on the subject of technical information are fully applicable to the pharmaceutical environment. Thus in Spain, for example, pharmaceuticals are the third sector in terms of investment, behind automobiles and food. The two questions we must ask are whether there would be less investment and poorer results if patents did not exist, and to what extent results are achieved with the existing patent protection. Nevertheless, these two questions are not easy to answer. Furthermore,... 

The application of thermodynamic models to the correlation and prediction of pharmaceutical solubility behaviour is an underutilized technique in today s process research and development environment. This is due to the relatively poor accuracy and limited predictive ability of the previous generation of models. Recent advances in computational chemistry and an increased focus on the life science sectors has led to the development of more appropriate models with significantly improved predictive capabilities. The NRTL-SAC and Local UNIFAC approaches will be discussed here with additional examples given in section 8. 

The global pharmaceutical industry is continuously growing in a rapidly changing and dynamic environment of the health care sector. New drugs and delivery systems... 

The development of pharmaceutical legislation in Tunisia cannot be disassociated from the scientific, economic and social environments. In fact, since its independence in 1956, Tunisia has chosen national public industries in different sectors including medicinal products. Such a policy was fully justified since Tunisian s primary concern was to provide the local market with a range of basic medicinal products to face the prevailing epidemics (e.g., tuberculosis, typhoid fever and scabies) in addition to usual disccises. 

In some industries, special material characteristics, such as heat and/or pressure sensitivity, toxicity, reactivity, etc., are of importance. Particularly in the pharmaceutical industry and some sectors of chemistry these parameters must be considered. While pressure agglomeration methods have only limited applicability for heat- and/or pressure-sensitive materials, toxicity may limit the appeal of tumble agglomeration because of the difficulty to contain dust and avoid contamination of the environment. 

We now address the question Why separate enantiomers What is the compelling reason for resolving racemic mixtures anyway For many years there was little impetus to separate enantiomers other than for the sake of knowledge scientists were simply interested in studying the behavior of these stereoisomers in different environments. In the industrial sector there was no reason to separate enantiomers. Even in the pharmaceutical business where it was recognized that the enantiomeric forms of chiral drugs can, and usually do, behave differently there was little focus on chiral synthesis and even less on chiral separations until recently. 

Also in nonliving (natural) systems, for instance, in the biomedical, pharmaceutical, and the agri-food sectors, most (nanostructured) objects owe their existence to their aqueous environment. Not only their existence but also their shape and spatial structure is to a large extent determined by the interaction with water. Two questions arise inunediately (1) which properties make water so special, and (2) how can these properties be explained and understood on a molecular level ... 

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