Accelerated Development of Solid Oral Dosage Formulation for IND Submission: Strategies for Rapid Execution and Compliance

Unlock the blueprint for rapid and efficient pharmaceutical development with our latest case study. The pharmaceutical industry’s demand for complex, multi-API drug formulations continues to grow, posing significant challenges in formulation and regulatory compliance. This case study showcases an accelerated approach to developing solid oral dosage forms using the innovative roller compaction process. Discover how we achieved high-quality, scalable formulations within tight timelines while meeting rigorous regulatory standards.

In this case study you will learn:

• How to optimize timelines for accelerated IND submission without compromising quality or regulatory compliance.
• How the roller compaction process enhances efficiency and scalability in the development of solid oral dosage forms.
• Best practices for designing formulations, including excipient selection, stability considerations, and API compatibility.
• Detailed techniques for ensuring precise and reliable analytical validation methods for multi-API products.
• Key success metrics, including improved dissolution rates, enhanced stability, and overall product quality.