Regulatory aspects on nanomedicines

Biochemical and Biophysical Research Communications

Volumn 468, Issue 3, 2015, Pages 504-510

  Sainz, Vanessa ^a   Conniot, João ^a   Matos, Ana I ^a   Peres, Carina ^a   Zupančič, Eva ^a   Moura, Liane ^a   Silva, Liana C ^a   Florindo, Helena F ^a   Gaspar, Rogério S ^a  

^a RESEARCH INSTITUTE FOR MEDICINES IMED ULISBOA   (Portugal)

Author keywords

"Quality by design"; Biocompatibility; Manufacturing; Nanomedicine; Nanotechnology; Regulatory sciences

Indexed keywords

BIOCOMPATIBILITY; DRUG MANUFACTURE; DRUG RESEARCH; GOVERNMENT REGULATION; HUMAN; MEDICAL RESEARCH; NANOMEDICINE; PRIORITY JOURNAL; REVIEW; SCIENCE; DRUG APPROVAL; INTERNATIONAL COOPERATION; LEGISLATION AND JURISPRUDENCE;

NANOPARTICLE;

DRUG APPROVAL; GOVERNMENT REGULATION; INTERNATIONALITY; NANOMEDICINE; NANOPARTICLES;

EID: 84951569805     PISSN: 0006291X     EISSN: 10902104     Source Type: Journal    
DOI: 10.1016/j.bbrc.2015.08.023     Document Type: Review

References (51)

1. F. Sanchez, and K. Sobolev Nanotechnology in concrete - a review Constr. Build. Mater. 24 2010 2060 2071
2. R.M. Navalakhe, and T.D. Nandedkar Application of nanotechnology in biomedicine Indian J. Exp. Biol. 45 2007 160 165
3. S. Shrivastava, and D. Dash Applying nanotechnology to human health: revolution in biomedical sciences J. Nanotechnol. 2009 2009 14
4. S.K. Sahoo, S. Parveen, and J.J. Panda The present and future of nanotechnology in human health care Nanomedicine 3 2007 20 31
5. R. Duncan, and R. Gaspar Nanomedicine(s) under the microscope Mol. Pharm. 8 2011 2101 2141
6. J. das Neves, M.M. Amiji, M.F. Bahia, and B. Sarmento Nanotechnology-based systems for the treatment and prevention of HIV/AIDS Adv. Drug Deliv. Rev. 62 2010 458 477
7. M. Ferrari Cancer nanotechnology: opportunities and challenges Nat. Rev. Cancer 5 2005 161 171
8. O.C. Farokhzad, and R. Langer Impact of nanotechnology on drug delivery ACS Nano 3 2009 16 20
9. S.M. Moghimi, A.C. Hunter, and T.L. Andresen Factors controlling nanoparticle pharmacokinetics: an integrated analysis and perspective Annu. Rev. Pharmacol. Toxicol. 52 2012 481 503
10. B.R. Dorbeck-Jung, and N. Chowdhury Is the European medical products authorisation regulation equipped to cope with the challenges of nanomedicines? Law Policy 33 2011 276 303
11. R. Wang, P.S. Billone, and W.M. Mullett Nanomedicine in action: an overview of cancer nanomedicine on the market and in clinical trials J. Nanomater. 2013 2013 12
12. V. Wagner, A. Dullaart, A.K. Bock, and A. Zweck The emerging nanomedicine landscape Nat. Biotechnol. 24 2006 1211 1217
13. R.S. Gaspar Therapeutic products: regulating drugs and medical devices G.A. Hodge, D.M. Bowman, A.D. Maynard, International Handbook on Regulating Nanotechnologies 2010 Edward Elgar Publishing Limited Northampton, MA, USA 291 320
14. R. Gaspar, H. Florindo, L. Silva, M. Videira, M.L. Corvo, B. Martins, and B. Silva-Lima Regulatory aspects of oncologicals: nanosystems main challenges M.J. Alonso, M. Garcia-Fuentes, Nano-oncologicals 2014 Springer International Publishing 425 452
15. M.A. Dobrovolskaia, and S.E. McNeil Understanding the correlation between in vitro and in vivo immunotoxicity tests for nanomedicines J. Control Release 172 2013 456 466
16. F. Ehmann, K. Sakai-Kato, R. Duncan, D. Hernan Perez de la Ossa, R. Pita, J.M. Vidal, A. Kohli, L. Tothfalusi, A. Sanh, S. Tinton, J.L. Robert, B. Silva Lima, and M.P. Amati Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines Nanomedicine (Lond) 8 2013 849 856
17. R. Gaspar, and R. Duncan Polymeric carriers: preclinical safety and the regulatory implications for design and development of polymer therapeutics Adv. Drug Deliv. Rev. 61 2009 1220 1231
18. S. Tinkle, S.E. McNeil, S. Mühlebach, R. Bawa, G. Borchard, Y. Barenholz, L. Tamarkin, and N. Desai Nanomedicines: addressing the scientific and regulatory gap Ann. N. Y. Acad. Sci. 1313 2014 35 56
19. S.M. Moghimi, and T.L. Andresen Complement-mediated tumour growth: implications for cancer nanotechnology and nanomedicines Mol. Immunol. 46 2009 1571 1572
20. P. Aggarwal, J.B. Hall, C.B. McLeland, M.A. Dobrovolskaia, and S.E. McNeil Nanoparticle interaction with plasma proteins as it relates to particle biodistribution, biocompatibility and therapeutic efficacy Adv. Drug Deliv. Rev. 61 2009 428 437
21. J. Conniot, J.M. Silva, J.G. Fernandes, L.C. Silva, R. Gaspar, S. Brocchini, H.F. Florindo, and T.S. Barata Cancer immunotherapy: nanodelivery approaches for immune cell targeting and tracking Front. Chem. 2 2014 105
22. W. Cai, and X. Chen Preparation of peptide-conjugated quantum dots for tumor vasculature-targeted imaging Nat. Protoc. 3 2008 89 96
23. R.K. Tekade, P.V. Kumar, and N.K. Jain Dendrimers in oncology: an expanding horizon Chem. Rev. 109 2009 49 87
24. M.E. Ruiz, M.E. Gantner, and A. Talevi Applications of nanosystems to anticancer drug therapy (Part II. Dendrimers, micelles, lipid-based nanosystems) Recent Pat. Anticancer Drug Discov. 9 2014 99 128
25. A. Bianco, K. Kostarelos, C.D. Partidos, and M. Prato Biomedical applications of functionalised carbon nanotubes Chem. Commun. (Camb) 2005 571 577
26. A. Bianco, K. Kostarelos, and M. Prato Applications of carbon nanotubes in drug delivery Curr. Opin. Chem. Biol. 9 2005 674 679
27. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q8, Pharmaceutical Development. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Tripartite Guideline 2009 ICH Geneva
28. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q9, Quality Risk Management. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Tripartite Guideline 2005 ICH Geneva
29. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q10, Pharmaceutical Quality System. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Tripartite Guideline 2008 ICH Geneva
30. G.A. Kwong, C.G. Radu, K. Hwang, C.J. Shu, C. Ma, R.C. Koya, B. Comin-Anduix, S.R. Hadrup, R.C. Bailey, O.N. Witte, T.N. Schumacher, A. Ribas, and J.R. Heath Modular nucleic acid assembled p/MHC microarrays for multiplexed sorting of antigen-specific T cells J. Am. Chem. Soc. 131 2009 9695 9703
31. A.E. Nel, L. Madler, D. Velegol, T. Xia, E.M.V. Hoek, P. Somasundaran, F. Klaessig, V. Castranova, and M. Thompson Understanding biophysicochemical interactions at the nano-bio interface Nat. Mater. 8 2009 543 557
32. S. Chapman, M. Dobrovolskaia, K. Farahani, A. Goodwin, A. Joshi, H. Lee, T. Meade, M. Pomper, K. Ptak, J. Rao, R. Singh, S. Sridhar, S. Stern, A. Wang, J.B. Weaver, G. Woloschak, and L. Yang Nanoparticles for cancer imaging: the good, the bad, and the promise Nano Today 8 2013 454 460
33. H.S. Choi, and J.V. Frangioni Nanoparticles for biomedical imaging: fundamentals of clinical translation Mol. Imaging 9 2010 291 310
34. M.Q. Smith, C.A. Staley, D.A. Kooby, T. Styblo, W.C. Wood, and L. Yang Multiplexed fluorescence imaging of tumor biomarkers in gene expression and protein levels for personalized and predictive medicine Curr. Mol. Med. 9 2009 1017 1023
35. A. Hafner, J. Lovric, G.P. Lakos, and I. Pepic Nanotherapeutics in the EU: an overview on current state and future directions Int. J. Nanomedicine 9 2014 1005 1023
36. M.L. Etheridge, S.A. Campbell, A.G. Erdman, C.L. Haynes, S.M. Wolf, and J. McCullough The big picture on nanomedicine: the state of investigational and approved nanomedicine products Nanomedicine 9 2013 1 14
37. R. Bawa Regulating nanomedicine - can the FDA handle it? Curr. Drug Deliv. 8 2011 227 234
38. M. Orme, F. Sjöqvist, D. Birkett, K. Brøsen, I. Cascorbi, L.L. Gustafsson, S. Maxwell, L. Rago, M. Rawlins, M. Reidenberg, F. Sjöqvist, T. Smith, P. Thuerman, and A. Walubo Clinical pharmacology in research, teaching and health care Basic Clin. Pharmacol. Toxicol. 107 2010 531 559
39. C. Main, L. Bojke, S. Griffin, G. Norman, M. Barbieri, L. Mather, D. Stark, S. Palmer, and R. Riemsma Topotecan, pegylated liposomal doxorubicin hydrochloride and paclitaxel for second-line or subsequent treatment of advanced ovarian cancer: a systematic review and economic evaluation Health Technol. Assess. 10 2006 1 132 iii-iv
40. C. Demetzos, and N. Pippa Fractal geometry as a new approach for proving nanosimilarity: a reflection note Int. J. Pharm. 483 2015 1 5
41. R. Gaspar, B. Aksu, A. Cuine, M. Danhof, M.J. Takac, H.H. Linden, A. Link, E.M. Muchitsch, C.G. Wilson, P. Ohrngren, and L. Dencker Towards a European strategy for medicines research (2014-2020): the EUFEPS position paper on Horizon 2020 Eur. J. Pharm. Sci. 47 2012 979 987
42. European Medicines Agency Reflection Paper on Non-clinical Studies for Generic Nanoparticle Iron Medicinal Product Applications 2011 EMA London
43. European Medicines Agency Joint MHLW/EMA Reflection Paper on the Development of Block Copolymer Micelle Medicinal Products 2013 EMA London
44. European Medicines Agency Reflection Paper on the Data Requirements for Intravenous Liposomal Products Developed with Reference to an Innovator Liposomal Product 2013 EMA London
45. H. Schellekens, S. Stegemann, V. Weinstein, J.B. de Vlieger, B. Flühmann, S. Mühlebach, R. Gaspar, V. Shah, and D.A. Crommelin How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider AAPS J. 16 2014 15 21
46. C. Holloway, J. Mueller-Berghaus, B.S. Lima, S. Lee, J.S. Wyatt, J.M. Nicholas, and D.J.A. Crommelin Scientific considerations for complex drugs in light of established and emerging regulatory guidance Ann. N. Y. Acad. Sci. 1276 2012 26 36
47. D.A. Crommelin, J.B. de Vlieger, V. Weinstein, S. Mühlebach, V. Shah, and H. Schellekens Different pharmaceutical products need similar terminology AAPS J. 16 2014 11 14
48. S.E. McNeil Characterization of Nanoparticles Intended for Drug Delivery 2011 Springer
49. R. Gaspar Nanoparticles: pushed off target with proteins Nat. Nanotechnol. 8 2013 79 80
50. J.M. Silva, M. Videira, R. Gaspar, V. Preat, and H.F. Florindo Immune system targeting by biodegradable nanoparticles for cancer vaccines J. Control Release 168 2013 179 199
51. M. Videira, A. Arranja, D. Rafael, and R. Gaspar Preclinical development of siRNA therapeutics: towards the match between fundamental science and engineered systems Nanomedicine 10 2014 689 702