Drug development and testing

Many substances can affect metabolic processes by influencing the activity of enzymes. Enzyme inhibitors are particularly important here. A large proportion of medicines act as enzyme inhibitors. Enzyme-kinetic experiments are therefore an important aspect of drug development and testing procedures. Natural metabolites are also involved in regulatory processes as inhibitors (see p.ll4). 

The variety of fields in which a chemist can work is extensive. Because chemistry is such a broad science, chemists can work on the interface with many other sciences, and even move into other fields. The primary area, of course, is the chemical industry, pharmaceuticals, polymers and plastics, semiconductor and other solid-state materials, and related fields. Examples of activities include research, quality control and property testing, and customer service. In other areas, modern medicine depends heavily on chemistry and involves many chemists in drug development and testing. Forensic science has a very large chemistry component, and many forensic scientists are in fact chemists. These are just a few of the fields in which chemistry plays a role. 

DRUG DEVELOPMENT AND TESTING The Food and Drug Administration (FDA)... 

S. Riegelman, Dissolution Testing in Drug Development and Quality Control, The Academy of Pharmaceutical Sciences Task Force Committee, American Pharmaceutical Association, 1979, p. 31. 

R D Focus. This database service [66] provides information on over 7000 drugs in active development. The service monitors the development, efficacy, and status of pharmaceuticals from early clinical testing through to launch. Data are gathered through direct contact with manufacturers and research organizations. It appraises both the scientific and commercial aspects of drug development and is searchable by product, by phase, by mechanism of action, and by country. R D Focus product is commercially available in several formats. 

Rifaximin is broad-spectrum antibiotic, which covers many skin pathogens, whose lack of transcutaneous absorption has been well documented by both animal [8] and human [9] studies. On these grounds, a topical formulation (i.e. cream) containing 5% of the active compound was developed and tested in the treatment of pyogenic skin infections. Some open trials [20, 21] showed the efficacy and safety of the formulation and pointed out the lack of selection of resistant strains after topical application of rifaximin. In any event, drug delivery from the topical formulation is orders of magnitude higher than the... 

In light of the low predictive values of many pharmacogenetic tests, two other situations in which pharmacogenetic testing has been heralded need closer inspection their use in drug development and as a substitute for prescribing on an ethnic-racial basis. 

Needham D, Dewhirst MW. The development and testing of new temperature-sensitive drug delivery system for treatment of solid tumors. Adv Drug Deliv Rev 2001 53 285-305. 

To support the development activities, accurate and sensitive analytical methods are required. With progress in development, increasing method validation work is performed and the acceptance criteria for drug quality and test method precision are tightened. 

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