Chapter 7

How New Drugs are Developed: Manufacturing and cGMP

Robert E. Smith


If a drug formulation is proved to be safe and effective on animals, more must be developed for experimenting on humans. Before this can happen, an Investigational New Drug Application (IND) must be filed with the FDA. FDA has a set of quality controls for drug manufacturing, called current Good Manufacturing Practice, or cGMP. The FDA audits manufacturing organization and has the authority to issue FDA form 483 and a warning letter. Methods used to analyze new chemical entities include UV-Vis and fluorescence spectrophotometry, HPLC and UPLC, ion chromatography, gas chromatography (GC), mass spectrometry (MS), GC-MS, LC-MS, IR and NMR. UV-Vis spectrophotometry measures the absorbance of UV and/or visible light. The wavelengths absorbed depend on the type of compound being analyzed and the amount of absorbance is depends on the amount present in the sample. Fluorescence spectrophotometry measures the emission of light that occurs at a longer wavelength than the light that is used for excitation. Ion chromatography separates and detects ions. Gas chromatography separates molecules in the gas phase and detects them using any of a number of detectors, including MS. Infrared (IR) spectroscopy measures the absorbance of IR light, which provides information about the compound being analyzed. NMR measures the absorbance of radio frequency electromagnetic radiation when organic compounds are placed in a strong magnetic field. It can tell the analyst the number of hydrogen and carbon atoms present in the sample, along with the hydrogens and carbons to which they are bound.

Total Pages: 188-238 (51)

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