1. Failure mode and effects analysis (FMEA) for immunogenicity of therapeutic proteins;Chirmule;J Pharm Sci,2020
2. Assessing the financial benefits of faster development times: the case of single-source versus multi-vendor outsourced biopharmaceutical manufacturing;DiMasi;Clin Ther,2018
3. Digitalization in pharmaceutical industry: what to focus on under the digital implementation process?;Hole;Int J Pharm X,2021
4. The gap between development and manufacturing in gene therapy: strategic options for overcoming traps;Nishida;Drug Discov Today,2023
5. FDA warning letters: a retrospective analysis of letters issued to pharmaceutical companies from 2010-2020;Rathore;j pharm innov,2022