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Updated: Mar 15, 2026

Registered Bioimaging of Nanomaterials for Diagnostic and Therapeutic Monitoring
Published on: December 9, 2010
Early Development Challenges for Drug Products Containing Nanomaterials
Jennifer H Grossman1, Rachael M Crist2, Jeffrey D Clogston2
1Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, 8560 Progress Drive, Wing D, Rm 1003, Frederick, Maryland, 21702, USA. jennifer.grossman@fnlcr.nih.gov.
Early preclinical experiments can identify nanomedicine failures, saving resources. Prioritizing these tests helps avoid costly late-stage setbacks for drug candidates.
Area of Science:
- Pharmaceutical Sciences
- Nanotechnology
- Drug Development
Background:
- Most drug candidates, including nanomedicines, fail in early development.
- Nanomedicine development presents unique challenges not seen with traditional therapeutics.
- Unexpected failures can arise from factors specific to nanomaterial-based drugs.
Purpose of the Study:
- To review critical early preclinical experiments for nanomedicine development.
- To provide data for "go/no-go" decisions in nanomedicine progression.
- To highlight experiments that reveal fundamental flaws requiring redesign.
Main Methods:
- Focus on experiments addressing unique nanomedicine failure points.
- Review of studies providing early decision-making data.
- Analysis of challenges distinct from small molecule or biopharmaceutical development.
Main Results:
- Certain experiments effectively identify potential nanomedicine failures early.
- These tests provide crucial "go/no-go" decision data.
- Identifying issues early prevents extensive rework and wasted resources.
Conclusions:
- Prioritizing specific early experiments accelerates failure detection in nanomedicine development.
- This strategy saves significant time and resources.
- Focusing on derisked candidates increases the likelihood of successful drug product development.
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