Clinical/pharmaceutical applications

Gas chromatography is widely used for the analysis of a diverse array of samples in environmental, clinical, pharmaceutical, biochemical, forensic, food science, and petrochemical laboratories. Examples of these applications are discussed in the following sections. 

Potentiometric enzyme-based electrodes have found application in clinical, pharmaceutical, food and biochemical analyses to enable the selective determination of a wide range of important enzyme substrates, including amino acids, esters, amides, acylcholines, /Mactam antibiotics, sugars, enantioselective drugs and many others [74]. 

A Sponsor submits a clinical trial application to the Competent Authority in each member state where the trials are to be conducted. The Competent Authority has 60 days to review and approve or reject the application. Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing, and quality controls on the drug, and supporting data, such as (1) chemical, pharmaceutical, and biological data, (2) nonclinical pharmacological and toxicological data, and (3) clinical data and previous human experience. The supporting data are submitted in the Common Technical Document (CTD) format (see Section 7.11). 

Analysis of small ions has been published for many applications other than pharmaceutical applications, and has a growing impact in industrial, environmental, biomedical, clinical, and forensic laboratories. Sample matrices range from simple tap water to Kraft black liquor, including river and seawater, beer and wine, environmental water, and nuclear plant water, but also body fluids such as serum, urine, plasma, cerebrospinal fluid, and many others. Those topics alone would require a separate book. 

The most prominent field of applications for microchip—MS concerns identification and analysis of large molecules in the field of proteomics according to the reduced separation time compared to conventional approaches such as gel-based methods for protein analysis. High-throughput analyses, with lower contamination and disposability, are other features of microfabricated devices that allow the fast screening of proteomic samples in the clinical field. Applications also include the analysis of low-molecular-weight compounds such as peptides or pharmaceutical samples. 

Figure 21 Launched 1,2-diazine derivatives with pharmaceutical applications and some products in clinical trials.

Interest in the development of synthetic schemes and approaches to create molecular recognition elements has blossomed during the past half century for a number of reasons. In contrast to biologically based receptors, artificial mimics have the potential advantages of being less costly, more stable, and better able to withstand harsher conditions.7-12 Furthermore, synthetic methodologies can be used to create receptors for molecules for which an artificial receptor does not exist. These designer materials have enormous potential in catalysis, clinical and pharmaceutical applications, chemical sensors, separation science, and electronics.7-12... 

Although robotics can be used in virtually all analytical areas, its major applications encompass the clinical, pharmaceutical and biotechnological fields. 

ICP-MS and on-hne LC-ICP-MS are primarily used for element speciation in environmental, food-related, and clinical applications. Its use in metabolism stndies is more recent [66-67], Bromine-specific detection by LC-ICP-MS in conjnnction with LC-MS has been apphed to selectively find the bromine-containing metabolites of 4-bromoaniline [66] in rat mine, while chlorine and sulfur-specific detection was applied in a metabohte stndy on diclofenac [67], Pharmaceutical applications of LC-ICP-MS were reviewed [68],... 

Most major clinical pharmaceutical manufacturers recognize that it is not profitable to develop a drug just for one region. In the past, most drugs were introduced first in Europe, even by US-based firms for pricing reasons, often country by country, and in Japan even later. This has dramatically changed since the Prescription Drug User Fee Act, which speeded up US approvals and the introduction of the centralized procedure of Application for Europe. Frequently, firms will conduct multicentre studies in both the United States and Europe and submit them almost simultaneously to the FDA and EMEA. This was not possible to do for Japan now it is Indeed, Japan now can conduct studies in other... 

Together, these changes have expanded the spectrum of research opportunities for clinical pharmaceutical scientists and have fostered the continued evolution of the definition. The term translational research has evolved to define scientific endeavors that provide a critical link between research theory and human application. The result is that today, there is variety in the types of clinical pharmaceutical scientists to be found, which is in fulfillment of the Millis Commission imperative. 

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