From Quantification to Translation: Advanced Bioanalytical Strategies for Evaluating Targeted Drug Delivery Systems
Buduru Gowthami1, Harshitha K S1, Sania Hermain1
1Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, India.
Critical Reviews in Analytical Chemistry
|August 5, 2026
Summary
Targeted drug delivery systems (TDDS) show promise, but bioanalytical challenges hinder clinical use. New methods are needed to overcome issues like protein corona formation and regulatory hurdles for successful translation.
Area of Science:
- Biomedical Engineering
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Targeted Drug Delivery Systems (TDDS) offer enhanced therapeutic efficiency via selective drug targeting.
- Clinical translation of TDDS is limited by significant bioanalytical challenges.
- Existing bioanalytical methods are inadequate for characterizing complex TDDS.
Purpose of the Study:
- To review current bioanalytical methods for TDDS assessment.
- To identify key challenges in TDDS bioanalysis and clinical translation.
- To explore emerging technologies for overcoming these obstacles.
Main Methods:
- Comprehensive literature review of bioanalytical techniques for TDDS.
- Analysis of challenges including drug separation, protein corona, matrix effects, biodistribution, and low-concentration detection.
- Evaluation of translational bottlenecks: standardization, regulation, validation, and scaling.
- Exploration of novel approaches: AI, multi-omics, biosensing, personalized assessment, and digital twins.
Main Results:
- Current bioanalytical methods face limitations in characterizing TDDS structure, dynamics, and function.
- Significant challenges exist in separating encapsulated/released drugs, managing protein corona, and addressing matrix effects.
- Translational bottlenecks include non-standardized protocols, regulatory hurdles, and validation difficulties.
- Emerging technologies like AI and digital twins show potential for improving TDDS bioanalysis.
Conclusions:
- Standardized and integrated bioanalytical frameworks are crucial for successful TDDS development.
- Overcoming bioanalytical and translational challenges is essential for advancing next-generation TDDS.
- Novel approaches are needed to bridge preclinical evaluation with clinical application of TDDS.
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