Patient-Centric Quality Standards.

Area of Science:

• Pharmaceutical Sciences
• Drug Development
• Regulatory Science

Background:

• Traditional pharmaceutical quality control relies on testing known attributes with limits from preclinical/clinical studies.
• Not all quality attributes significantly impact patient safety or efficacy at therapeutic doses.
• Existing strategies may not fully capture patient relevance for product control.

Purpose of the Study:

• To introduce the concept of patient-centricity in pharmaceutical quality standards.
• To define patient-relevant attributes and their impact on safety and efficacy within exposure ranges.
• To describe the creation and application of patient-centric quality standards (PCQS).

Main Methods:

• Review of historical perspectives in pharmaceutical product control.
• Definition of patient relevance for quality attributes.
• Framework for developing and leveraging patient-centric quality standards (PCQS).

Main Results:

• Patient-centricity involves understanding the impact of quality attributes on safety and efficacy at patient-relevant levels.
• A patient-centric quality standard (PCQS) comprises patient-relevant attributes and acceptance ranges.
• PCQS can be applied across various pharmaceutical product types.

Conclusions:

• Shifting to patient-centric quality standards enhances the focus on patient safety and therapeutic efficacy.
• PCQS provides a framework for setting meaningful acceptance criteria for drug products.
• This approach optimizes manufacturing process and product control strategies for patient benefit.