Pharmaceutical products safety

Actually, the successful use of cationic surfactants (cSurf), as flotation reagents, frothers, metal corrosion inhibitors, pharmaceutical products, cosmetic materials, stimulates considerable increase in their production and as a result increases their content in natural water. As cationic surfactants are toxic pollutants in natural water and their maximum contaminant level (MCL) of natural water is 0.15-4.0 mg/dm, it is necessary to use methods for which provide rapid and reliable determination with sensitivity equal to at least 0.1 of MCL. Practically most sensitive methods of cationic surfactant determination include the preconcentration by extraction or sorption. Analytical methods without using organic solvents are more preferable due to their ecological safety. 

The sole objective of all hygiene and manufacturing controls is to ensure the quality of the pharmaceuhcal product for the safety and protection of the pahent. The manufacture of non-sterile pharmaceutical products requires that certain criteria of cleanliness, personal hygiene, produchon methods and storage must be met. Many such products are for oral and topical use and the question may fairly be posed as to the point of what are now quite stringent conditions. Nevertheless, some carefully controlled hospital studies have indeed shown that both types of medicine may be associated with nosocomial (hospital-acquired) infections and this risk can be minimized by the application of GMP principles. 

The National Pharmaceutical Control Bureau shall ensure the quahty and safety of pharmaceutical products through the implementation of the relevant legislation by a competent workforce working together in strategic alliance towards improving the health of the people. ... 

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

Each dmg regulatory function helps to ensure the efficacy, safety and quality of pharmaceutical products and their rational use. Dmg regulation should therefore be carried out in such a way that each function receives sufficient attention and resources. Yet experiences in the countries studied indicate that the different dmg regulatory functions receive varying degrees of emphasis. The disparities are found in three key areas. 

Homogeneous catalysis has an important role to play in enantioselective reactions. To improve product safety, the pharmaceutical industry is producing an increasing number of products in enantiomerically pure form. Other important (future) markets include agrochemicals, polymers and fine chemicals. Although the number of practised processes is quite small the potential is high. 

It is further stated that any individuals who have an apparent illness or open lesions that could in any way affect the safety and quality of drugs shall be excluded from direct contact with the pharmaceutical products being prepared. It may be necessary to assign these individuals temporarily to other duties until they are in satisfactory health. It is imperative that the employees be instructed to report any of the foregoing conditions to their supervisors. The supervisory personnel have additional responsibility to ensure that this requirement is met. 

The most useful pharmacokinetic variable for describing the quantitative aspects of all processes influencing the absorption (fa) and first-pass metabolism and excretion (Eg and Eh) in the gut and liver is the absolute bioavailability (F) [40]. This pharmacokinetic parameter is used to illustrate the fraction of the dose that reaches the systemic circulation, and relate it to pharmacological and safety effects for oral pharmaceutical products in various clinical situations. The bioavailability is dependent on three major factors the fraction dose absorbed (fa) and the first-pass extraction of the drug in the gut wall (EG) and/or the liver (EH) (Eq. (1)) [2-4, 15, 35] ... 

The production of pharmaceutical proteins in plants has clear advantages over traditional systems in terms of cost-efficiency and product safety, since there is no risk of contamination with human pathogens. Furthermore plants are much less likely than mammalian cells to be affected by the expression of certain human proteins, such as growth factors and cell cycle inhibitors [29]. Therefore, plants provide a strategic complement to existing microbial and animal production systems. 

In the pharmaceutical industry, acute toxicity testing has uses other than for product safety determinations. First, as in other industries, acute toxicity determinations are part of industrial hygiene or occupational health environmental impact assessments (Deichmann and Gerarde, 1969). These requirements demand testing not only for finished products but frequently of intermediates as well. These issues and requirements, however, are discussed in Chapter 2 and are not directly addressed here. 

Pharmaceutical and device development (particularly the product safety assessment aspects of it) cannot continue to be performed as it has been traditionally (on ethical, economic, or competitive grounds). 

At present, despite the advantages offered by the buccal delivery route, such as the bypass of intestinal and hepatic first-pass metabolism for systemic delivery, very few pharmaceutical products employ this route of administration. The reasons that contribute to this situation include (1) high costs associated with development, (2) lack of standardized tests to identify drug candidates suitability for this route, (3) the limited understanding of the impact of metabolism and/or transporters found in the oral cavity mucosa on buccal delivery, and (4) the relatively small number of reports describing the usefulness and safety of excipients/permeation enhancers in humans [82, 83], Therefore, the... 

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