Chapter 11 · Book Chapter
Open Access Peer Reviewed

Toxicological and Regulatory Consideration

Ms. Sakshi S. Kohakade1, Mr. Sushant M. Ahire2, Ms. Prerana S. Pawar3

Abstract

Nanoparticle-based drug delivery systems (NDDS) have become a major advancement in cancer treatment, providing several benefits compared to traditional methods. This review looks at the various ways nanoparticles are used in cancer therapy and explains how they help in delivering drugs more effectively, reduce harmful effects on the body, and deal with issues like drug resistance and differences among tumors. Different types of nanoparticles, such as liposomes, polymeric nanoparticles, metallic nanoparticles, and newer ones like carbon nanotubes, dendrimers, and exosomes, are designed to deliver drugs directly to cancer cells. These nanoparticles improve how well drugs work in the body and help them accumulate at the tumor site through mechanisms like the enhanced permeability and retention (EPR) effect and by using ligands for active targeting. Nanoparticles are also important in combination therapies and targeting cancer stem cells (CSCs). Recent developments in smart nanoparticles that react to changes in their environment, such as pH or temperature, as well as their use with RNA-based therapies and artificial intelligence (AI) for personalized treatment, show the direction of future cancer nanomedicine. Although there has been progress, challenges like regulatory issues, safety concerns, and producing these systems on a large scale still need to be solved. This review gives an overview of the current state, challenges, and future possibilities of NDDS in cancer treatment, focusing on their potential to improve patient outcomes and change how cancer is treated.

NanoparticlesCancer therapyDrug deliveryMultidrug resistanceCombination therapyPersonalized medicineImmunotherapyChemotherapy

Author Affiliations

  • 1 Department of Pharmaceutics, TSSM's Jayawant Institute of Pharmaceutical Sciences & Research, Bavdhan, Pune - 411038, Maharashtra, India.
  • 2 Assistant Professor, Department of Pharmaceutical Chemistry, Divine College of Pharmacy, Satana.
  • 3 Assistant Professor, Department of Pharmaceutics, Divine College of Pharmacy, Satana.

How to Cite this Chapter

Kohakade, S. S., Ahire, S. M., & Pawar, P. S. (2026). Toxicological and Regulatory Consideration. In S. M. Ahire, P. S. Pawar, V. V. Shewale, & S. P. Jadhav (Eds.), Nanoparticle Mediated Drug Delivery Systems for Cancer Treatment: Advanced Nanotechnological Approaches in Targeted Cancer Therapy (pp. 264–283). WiseLeaf Scientific Ventures. https://doi.org/10.66079/wiseleaf.nanoparticle-cancer-thematic.2026
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