Course Description:
During the development of complex generic peptide products, the amount of comparative studies required by the FDA have been on an upward trend in recent years. It has been a challenge for generic applicants to plan such studies prior to the initial product development. As a result, upon receiving ANDA review feedbacks from the FDA, applicants may have to produce additional batches of the proposed products and acquire more RLD batches to perform the additionally required comparative studies. This inevitably causes significant delays in regulatory approval.
The proposed drug product and the RLD product in finished dosage form are usually used in comparative studies. Under certain situations, compendial standards (e.g., USP standards) may serve as the comparator. The purposes of such studies can be categorized as establishing the identity of the active ingredient, comparing impurity profiles, and demonstrating comparable properties of the proposed and the RLD products. There are certain pitfalls that applicants should be aware of and try to avoid in planning, along with performing, such comparative studies. These potential issues may include, but are not limited to, batch selection, sample manipulation, study time point, and data analysis. The presentation will provide an overview on comparative studies used in the development of complex peptide products and recommendations on how to plan such studies ahead of time.
The live version of this recording took place on March 1, 2021 and features
a presentation by Xiaohui (Jeff) Jiang, Ph.D.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.