Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles in Product Development and Regulatory Assessment

The purpose of this 2-day workshop is to facilitate an in-depth look at current challenges relating to LAI product characterization, drug release mechanisms, in vivo BE study conduct, and factors that impact product development and regulatory assessment. The workshop will discuss current thinking on LAI drug release mechanisms, in vitro methodologies, and predictive modeling approaches to support LAI generic drug development and regulatory assessment. Sessions will discuss common deficiencies observed during ANDA assessment, alternative BE study designs, and model-integrated evidence approaches that enable a more efficient and feasible BE assessment. The workshop will also facilitate a discussion about permissible formulation differences and their impact on product performance, reverse engineering approaches, and novel excipient evaluation strategies.