Considerations When Submitting Nanotherapeutics to FDA/CDER for Regulatory Review

Methods in Molecular Biology

Volumn 697, Issue , 2011, Pages 17-31

  Tyner, Katherine ^a   Sadrieh, Nakissa ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

characterization; nano pharmaceutics; Nano therapeutic; regulatory; safety assessment

Indexed keywords

DRUG; NANOMATERIAL; NANOPARTICLE;

ANIMAL; ARTICLE; CHEMISTRY; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; METHODOLOGY; PHARMACOKINETICS; PRACTICE GUIDELINE; UNITED STATES;

ANIMALS; DRUG APPROVAL; GUIDELINES AS TOPIC; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; NANOPARTICLES; NANOSTRUCTURES; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

MLCS; MLOWN;

EID: 79955812915     PISSN: 10643745     EISSN: 19406029     Source Type: Book Series    
DOI: 10.1007/978-1-60327-198-1_3     Document Type: Chapter

References (20)

1. Siegel, R.W., Hu, E., Roco, M.C. (eds.) (1999) Nanostructure Science and Technology. A Worldwide Study. National Science and Technology Council Committee on Technology, The Interagency working group on nanoscience, engineering and technology. International Technology Research Institute World Technology Division, Baltimore, MD.
2. Vogel, V., Baird, B. (eds.) (2003) Nanobio-technology. Report of the National Nanotechnology Initiative Workshop. National Nanotechnology Initiative, Arlington, VA.
3. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry Content and format of investigational new drug applications for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products. 1995 http://www.fda.gov/cder/guidance/phase1.pdf accessed February, 2008.
4. Warheit, D. (2008) How meaningful are results of nanotoxicity studies in the absence of adequate material characterization? Toxicol Sci 101, 183–185.
5. Oberdorster, G., Oberdorster, E., Oberdorster, J. (2005) Nanotoxicology: An emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect 113, 823–839.
6. Gaur, U., Sahoo, S., De, T., Ghosh, P., Maitra, A., Ghosh, P. (2000) Biodistribution of fluo-resceinated dextran using novel nanoparticles evading reticuloendothelial system. Int J Pharm 202, 1–10.
7. Liversidge, G., Cundy, K. (1995) Particle size reduction for improvement of oral bioavailability of hydrophobic drugs: I. Absolute oral bioavailability of nanocrystalline danazol in beagle dogs. Int J Pharm 125, 91–97.
8. Hu, J., Johnston, K., Williams, R. (2004) Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs. Drug Dev Ind Pharm 30, 233–245.
9. LaVan, D., McGuire, T., Langer, R. (2003) Small-scale systems for in vivo drug delivery. Nat Biotechnol 21, 1184–1191.
10. Nishiyama, N., Kataoka, K. (2006) Current state, achievements, and future prospects of polymeric micelles as nanocarriers for drug and gene delivery. Pharmacol Ther 112, 630–648.
11. Hezinger, A., Tebmar, J., Gopferich, A. (2008) Polymer coating of quantum dots – a powerful tool toward diagnostics and senso-rics. Eur J Pharm Biopharm 68, 138–152.
12. Dobson, J. (2006) Magnetic nanoparticles for drug delivery. Drug Dev Res 67, 55–60.
13. Castaldo, D. (2008) Identification of foreign particles below 10 microns key to inhaled drug quality. Pharmaceutical Processing. http://www.pharmpro.com/ShowPR.aspx? PUBCODE=021&ACCT=0000100&ISSUE =0405&RELTYPE=PR&Cat=0&SubCat=0 &ProdCode=0000&PRODLETT=R&Searc hText=aspex accessed April 1, 2008.
14. Adams, N., De Gans, B.-J., Kozodaev, D., Sanchez, C., Bastiaansen, C., Broer, D., Schubert, U. (2006) High-throughput screening and optimization of photoembossed relief structures. J Comb Chem 8, 184–191.
15. Draft Guidance Guidance for Industry, Analytical Procedures and Methods Validation, Chemistry, Manufacturing, and Controls Documentation, August 2000.
16. Magenheim, B., Benita, S. (1991) Nanoparticle characterization: A comprehensive physiochem-ical approach. STP Pharma Sci. 1, 221–241.
17. Bootz, A., Vogel, V., Schubert, D., Kreuter, J. (2004) Comparison of scanning electron microscopy, dynamic light scattering, and analytical ultracentrifugation for the sizing of poly(butyl cyanoacrylate) nanoparticles. Eur J Pharm Biopharm 57, 369–375.
18. Jillavenkatesa, J., Dapkunas, S., Lum, L.-S. (2001) NIST recommended practice guide special publication 960-1 Particle size characterization. NIST.
19. Murdock, R., Braydich-Stolle, L., Schrand, A., Schlager, J., Hussain, S. (2008) Characterization of nanomaterial dispersion in solution prior to in vitro exposure using dynamic light scattering technique. Toxicol Sci 101, 239–253.
20. Guidance for Industry and FDA Staff, Early Development Considerations for Innovative Combination Products, September 2006 (http://www. fda. gov/oc/combi nati on/innovative.html.