Preclinical, Clinical, and Translational Perspectives

Ashok Thulluru¹, Prajval A. Kothale¹, Somesh P. Chavan¹, Sarad Pawar Naik Bukke², Abhijeet D. Kulkarni³, VVS Reddy Karri^4,*

Corresponding author: [email protected]

Abstract

This chapter critically examines the preclinical, clinical and translational status of biodegradable polymers used in drug delivery and tissue engineering. It discusses the prerequisites for preclinical testing, emphasising robust in vitro/in vivo systems that predict immunological responses, biodegradation kinetics and pharmacokinetics, followed by current and completed clinical trials across targeted oncology, cardiovascular stents and regenerative medicine scaffolds. Particular emphasis is placed on commercialisation challenges such as large-scale GMP production, sterilisation and batch reproducibility, present-day regulatory systems, predictive biomarkers and the shift towards patient-specific polymeric interventions.

Author Affiliations

• ¹ Department of Pharmaceutics, D. Y. Patil Education Society (Deemed to be University), D. Y. Patil College of Pharmacy, Kadambwadi, Kolhapur-416003, Maharashtra, India.
• ² Department of Pharmaceutics & Pharmaceutical Technology, Kampala International University, Western Campus, PO BOX 71, Ishaka, Uganda.
• ³ Department of Pharmaceutics, School of Pharmaceutical Sciences, Sandip University, Mahiravani, Nashik-422213, Maharashtra, India.
• ⁴ Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Nilgiris, Ooty-643001, Tamil Nadu, India.

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