EPISODE 1 Regulatory CMC Considerations – Developing Modified Versions of Immediate Release Oral Solid Dosage Forms

Release date: January 29, 2024

The AudioCast discusses the key considerations for developing modified-release versions of immediate-release oral solid dosage forms. It covers the selection of release mechanisms, establishment of release profiles, understanding of regulatory requirements, formulation and manufacturing considerations, analytical testing methodologies, BCS classification and biowaiver, clinical development planning, and intellectual property protection. Additionally, it emphasizes the benefits of API characterization and pre-formulation work in terms of improving understanding of API properties, identifying formulation challenges, supporting regulatory submissions, and predicting product performance in the body. Lastly, it mentions the essential CMC development data required by health authorities for evaluating submissions, including formulation development, manufacturing processes, analytical method development and validation, stability data, in-vitro release studies, biopharmaceutical classification system and biowaiver, clinical development plans and data, and comparative data.