Scientific and Regulatory Considerations in Product Development

This chapter focuses on the scientific and regulatory considerations for developing amorphous solid dispersions (ASDs) of small-molecule drugs with poor aqueous solubility for oral administration. Drug development is a multistep and multidisciplinary process involving discovery, development, Food and Drug Administration (FDA) review and approval, and postapproval, postmarketing safety surveillance to ensure continued safety and efficacy of the drug. The approval process includes a comprehensive review of all data, similar to the FDA approval process, or a limited review if the drug has already been approved in one of the major foreign markets (the United States, Europe, and/or Japan). The harmonized aspects, that is, the International Conference on Harmonisation (ICH) guidelines, are adopted as law in several countries. Quality-by-design (QbD) is a systematic approach toward product development that begins with predefined objectives and emphasizes the use of sound science and quality risk management principles in product and process understanding and control.

Scientific and Regulatory Considerations in Product Development Chapter