Open Access Journals Of Pharmaceutical Analysis
Pharmaceutical analysis is traditionally defined as analytical chemistry dealing with drugs both as bulk drug substances and as pharmaceutical products (formulations). However, in academia, as well as in the pharmaceutical industry, other branches of analytical chemistry are also involved, viz. bioanalytical chemistry, drug metabolism studies, and analytical biotechnology. The development of drugs in the pharmaceutical industry is a long-term process, often taking more than a decade from the start of the research project to appearance of a drug on the market. That process involves several decision points, such as the choice of the candidate drug after the discovery phase, the application 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 based on substance analysis, and that knowledge is later used for quality control (QC) of the substance during full-scale production. Product analysis involves dealing with the various formulations used for toxicological studies, clinical studies, and marketing. The results from such work lead to specifications that form the basis for the QC of the product. For both substances and formulations there is an increasing interest in the introduction of process analytical chemistry.
Last Updated on: Nov 27, 2024