Challenges and Pathways in Regulating Next-Gen Biological Therapies
The review concludes that there is a need for worldwide regulatory harmonization and regulatory framework developments, including R.W.E., adaptive pathways, and personalization of biologics.
Authors
- Pravina Gurjar (ORCID: https://orcid.org/0000-0001-6740-1114)
- Sunita Vaidya
- Jitendra Patel (ORCID: https://orcid.org/0000-0001-8193-2878)
- Surendra Agrawal (ORCID: https://orcid.org/0000-0002-1149-5307)
- Pranita Jirvankar
Institutions
- Datta Meghe Institute of Higher Education and Research (IN)
Publication Details
- Journal
- Current Pharmaceutical Biotechnology
- Published
- 2025-04-23
- DOI
- https://doi.org/10.2174/0113892010367028250411111549
- Citations
- 3
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 3.49