Pharmaceuticals Safety Considerations

Humans and animals are prone to a variety of diseases and infections. Humans suffer due to known (identifiable) and unknown (not well diagnosed) diseases and ailments, making it imperative to introduce a number of newer drugs. Often, these conditions require multiple-drug therapy for an effective cure. In this context, the safety and efficacy of therapy is extremely important. 

Most prescriptions are official, and all details are available (e.g., list of ingredients, quantities, forms it must be dispensed). Despite these details, there are serious incompatibilities reported that may undergo physicochemical or therapeutic 

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Approval of pharmaceuticals by health authorities The decision we are faced with here is whether a particular drag should be on the market or not. Normally governments decide whether to approve or reject the marketing of drugs solely on the basis of effectiveness and safety considerations. Should/can economic evaluation play a part in this ... 

Economic and safety considerations encourage minimal stockpiling of chemicals and avoiding transportation of hazardous substances. These increasing demands offer many opportunities for microwave chemistry in the development of environmentally benign methods for the preparation of intermediates, specialty chemicals and pharmaceuticals [6[. It appears likely that within the next few years, individual chemical reactors will be required for diverse tasks and will need to be easily relocated... 

The formulations that are developed and used for preclinical studies are sometimes specific for the test species to be employed, but their development always starts with consideration of the route of exposure that is to be used clinically and, if possible, in accordance with a specified regimen of treatment (mirroring the intended clinical protocol, as much as possible). One aspect of both nonclinical and clinical formulation and testing which presents an important but often overlooked aspect of pharmaceutical safety assessment is the special field of excipients. These will be considered at the end of this chapter... 

In addition to the binding constant and safety considerations, economics, and quality control issues also play a role in considering which ligands to use. Because of the difLculty in selectively derivatizing a speciLc hydroxyl or family of hydroxyls, most modiLed CDs of pharmaceutical interest are likely to be complex mixtures (Stella and Rajewski, 1997). Methods to characterize these mixtures, therefore, need to be in place to assure lot-to-lot reproducibility. The costs of acute and chronic safety studies required to evaluate any new CD derivatives are very high, and this prohibits them from being widely evaluated for pharmaceutical applications. 

SVIs are simple formulations compared with other pharmaceutical dosage forms. Solution SVIs contain water, the active ingredient, and a minimal number of inactive added ingredients. Solid SVIs contain the active ingredient and usually one or two added ingredients. Formulation scientists have severe restrictions in number and choice of added substances because of safety considerations. 

The current or potential iadustrial appHcations of microemulsions iaclude metal working, catalysis, advanced ceramics processiag, production of nanostmctured materials (see Nanotechnology), dyeiag, agrochemicals, cosmetics, foods, pharmaceuticals, and biotechnology (9,12—18). Environmental and human-safety aspects of surfactants have begun to receive considerable attention (19—21). 

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. 

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

Even on a relatively small subset of reused data, it is possible to license old medicines for new therapeutic applications and greatly reduce the costs of clinical development—many of these reused medicines have already passed muster for pharmacokinetic safety, so smaller-scale clinical trials are possible, saving considerable money (e.g., Arakis—soon to become Sosei). Even Sildenafil may have new indications [39]. There are huge potential reserves of information to mine in each and every large pharmaceutical company ... 

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