Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug Development

www.pharmtech.com nalytical method development is a critical part of the drug development process. Analytical methods are used to check the quality of materials that will be used in clinical trials. As drug development progresses toward registration, these and other methods are used to generate information that will enable quality to be designed into the manufacturing processes of drug substances and formulated drug products. This practice can lead to a detailed understanding of production processes and the development of control mechanisms that will ensure product quality. Effective method development does not occur in a vacuum. Analytical scientists must interact with process chemists, pharmaceutical scientists, and process engineers (see Figure 1). The information needs of these development partners must be well understood to design appropriate methods for the intended use. Other key functions include quality assurance, regulatory, toxicology, medical, quality control, and largeand small-scale manufacturing. Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug Development