Formulation and Quality – Chemical
Complex systems are distinguished by having multiple interactive variables, structures, and relationships. In the realm of drug products, complexity may arise from the active ingredient, the formulation, the dosage form, route of delivery, device combinations, and various combinations thereof. The complexity of drug products has been increasing over the years, in part, to enhance the delivery of poorly soluble drugs, to increase drug delivery to traditionally un-druggable sites, and to meet the demands of increased focus on personalized and precision medicine. Historically, complex products have involved robust scientific and industry discussion throughout all aspects of the review process to insure the quality of these products for the US market. This presentation will discuss the interplay of critical quality attributes as they relate the review process of complex drug products. Applicable regulatory guidance and current regulatory programs will be discussed along with relevant case studies.
1. Understand the types of complexity typically found in complex drug products
2. Discuss the risk-based approach for determining and evaluating the critical quality attributes of complex drug products
3. Identify where additional guidances and resources may be found