ISSN: 2041-6792

Clinical Investigation

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Pharmaceutical analysis is generally defined as analytical chemistry dealing with drugs both as bulk drug substances and as pharmaceutical products (formulations). However, in academia, also as within the pharmaceutical industry, other branches of analytical chemistry also are involved, viz. bioanalytical chemistry, drug metabolism studies, and analytical biotechnology. The development of medicine within the pharmaceutical industry may be a long-term process, often taking quite a decade from the beginning of the scientific research to appearance of a drug on the market. That process involves several decision points, like the selection of the candidate drug after the invention phase, the appliance to the authorities before testing the compound for the first time in humans, and finally the new drug application for marketing, which summarizes the data obtained from all the studies needed for approval of the drug as a medicine. In all these steps the amount of data generated is enormous. Analytical chemists are involved in many of the studies that constitute this documentation. Substance quality and its specifications are supported substance analysis, which knowledge is later used for internal control (QC) of the substance during full-scale production. Product analysis involves handling the varied formulations used for toxicological studies, clinical studies, and marketing. The results from such work cause specifications that form the idea for the QC of the merchandise . For both substances and formulations there's an increasing interest within the introduction of process analytical chemistry.

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