In 2024, the FDA made updates to some Product Specific Guidance (PSG) that introduces the use of in vitro bioequivalence this regulatory shift aims to streamline approval processes, accelerate generic drug development, and promote more robust scientific approaches. But what does this mean for pharmaceutical developers, and how can they adapt their testing strategies to stay ahead?
Understanding Product-Specific Guidance (PSG) and Its Role in Drug Development
The FDA issues product-specific guidance (PSG) to provide recommendations for generic drug product development, these guidelines are tailored to specific drugs and outline acceptable methodologies.
For OINDPs, the FDA is shifting toward more science-driven approaches that emphasize in vitro assessments. This move reflects advancements in predictive testing and the need for faster, cost-effective generic drug approval processes.
IVIVC and Its Critical Role in Drug Development
In vitro-In vivo correlation (IVIVC) in OINDP is a methodology that provides better representation of the entire patient population by utilizing various realistic throat models and breathing profiles. A well-established IVIVC can:
- Reduce the need for expensive and time-consuming in vivo studies
- Improve formulation development by predicting in vivo performance based on in vitro data
- Optimize quality control processes by ensuring batch-to-batch consistency
Key FDA Changes and Their Impact on IVIVC Investigations
The 2024 PSG updates emphasize in vitro approaches, which rely on realistic aerodynamic particle size distribution (rAPSD) measurement. MSP’s product offering enables pharmaceutical manufacturers to establish IVIVC more efficiently. Our products provide its users with,
- Greater Reliance on In Vitro Testing
- Throat and nasal models designed around a range of patient profiles.
- Breathing Profiles that betters mimic a human subject.
- Streamlining Generic Drug Approval
- For generic inhalation drugs, these update changes the current pathway on how a drug obtains approval.
- Reducing dependency on in vivo pharmacodynamic bioequivalence study.
- Providing clear in vitro benchmarks for bioequivalence
- Improving IVIVC Models
- Advanced APSD measurements: Using Next-Generation Impactors (NGIs) to obtain precise aerodynamic size distributions
Adapting to the New Regulatory Landscape
As the industry introduces the importance of in vitro testing, pharmaceutical companies can stay ahead of required testing capabilities by aligning with the early-on FDA expectations. This includes:
- Exploring advanced analytical instrumentation for rAPSD
- Developing robust IVIVC models that can accurately predict in vivo drug performance
- Engaging with regulatory bodies early in the development process to ensure compliance with the latest PSG requirements
The Future of IVIVC and OINDP Testing
The FDA’s PSG updates mark a significant step toward a more efficient, scientifically rigorous approach to inhalation drug development. By prioritizing in vitro methodologies, these changes open new opportunities for optimizing IVIVC investigations.
Are your testing strategies prepared for this regulatory shift? Take advantage of cutting-edge in vitro testing solutions and IVIVC models that will not only ensure regulatory compliance but also accelerate drug development timelines. For pharmaceutical manufacturers, adapting to these evolving guidelines can be challenging, MSP is here to assist you in this process, please reach out to mspsales@tsi.com with any questions.