1. Suarez-Sharp S, Abend A, Hoffelder T, Leblond D, Delvadia P, Kovacs E, et al. In vitro dissolution profiles similarity assessment in support of drug product quality: what, how, when-workshop summary report. AAPS J. 2020;22(4):74.
2. Hoffelder T, Leblond D, Van Alstine L, Diaz DA, Suarez-Sharp S, Witkowski K, et al. Dissolution profile similarity analyses – statistical principles, methods and considerations. AAPS J. 2022(in press).
3. Anand O. FDA’s current practice and challenges in the evaluation of dissolution profile comparisons in support of minor/moderate product quality changes: case studies. In: Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How. Baltimore, MD: and When; 2019.
4. Fredro-Kumbaradzi E. Dissolution similarity applications in generic industry – issues and challenges: case studies. In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When. Baltimore, MD2019.
5. Kotzagiorgis E. EMA’s current practice and challenges in the evaluation of dissolution profile comparisons in support of minor/moderate product quality changes: case studies. In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, and When. Baltimore, MD2019.