The regulatory framework for glycoconjugate vaccines

ACS Symposium Series

Volumn 989, Issue , 2008, Pages 21-35

  Jones, Christopher ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOHYDRATES; IMMUNIZATION;

GLYCOCONJUGATE VACCINES; NATURAL EXPOSURE; REGULATORY FRAMEWORKS; VACCINE DEVELOPMENT;

VACCINES;

EID: 84892630550     PISSN: 00976156     EISSN: 19475918     Source Type: Book Series    
DOI: 10.1021/bk-2008-0989.ch002     Document Type: Conference Paper

References (64)

1. Jones, C. An. Bras. Acad. Cienc. 2005, 77, 293-324.
2. Wenger, J. D. Pediatr. Infect. Dis. J. 1998, 17, S132-S136.
3. Ramsay, M. E.; Andrews, N. J.; Trotter, C. L.; Kaczmarski,E. B.; Miller, E. BMJ 2003, 326, 365-366.
4. Whitney, C. G.; Farley, M. M.; Hadler, J.; Harrison, L. H.; Bennett, N. M.; Lynfield, R.; Reingold, A.; Cieslak, P. R.; Pilivili, T.; Jackson, D.; Facklam, R. R.; Jorgensen, J. H.; Schuchat, A. N. Eng. J. Med. 2003, 348, 1737-1746.
5. ICH Guidelines, http://www.ich.org/cache/compo/276-254-1.html.
6. World Health Organ. Tech. Rep. Ser. 2000, 897, 27-60.
7. World Health Organ. Tech. Rep. Ser. 2004, 924, 102-128.
8. World Health Organ. Tech. Rep. Ser. 2004, 926, 90-94.
9. World Health Organ. Tech. Rep. Ser. in press.
10. Code of Federal Regulation (CFR) http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm.
11. FDA guidance documents http://www.fda.gov/cber/guidelines.htm.
12. Eudra Lex: http://pharmacos.eudra.org/F2/eudralex/index.htm.
13. EU Clinical trials Directive http://europa.eu.int/eurlex/pri/en/oj/dat/ 2001/1-121/1-12120010501en00340044.pdf.
14. MHRA information on the implementation of EU Clinical Trials Directive http://medicines.mhra.gov.uk/ourwork/licensingmeds/types/clintrialdir.htm.
15. EMEA Notes for Guidances http://www.emea.eu.int/index/indexh1.htm.
16. European Pharmacopoeia 5th Edition, Strasbourg, 2005, pp 662-664.
17. European Pharmacopoeia 5th Edition, Strasbourg, 2005, pp 680-682.
18. European Pharmacopoeia 5th Edition, Strasbourg, 2005, pp 2851-2852.
19. Ball, L. K.; Falk, L. A.; Horne, A. D.; Finn, T. M. J. Infect. Dis. 2001, 33, S299-S305.
20. Sikkema, D. J.; Ziembiec, N. A.; Jones, T. R.; Hildreth, S. W.; Madore, D. V.; Quataert, S. A. Clin. Diagn. Lab. Immunol. 2005, 12, 218-223.
21. Quataert, S. A.; Rittenhouse-Olson, K.; Kirch, C. S.; Hu, B.; Secor, S.; Strong, N.; Madore, D. V. Clin. Diagn. Lab. Immunol. 2004, 11, 1064- 1069.
22. Reference materials: http://www.nibsc.ac.uk/products/catalogue.html. Some pneumococcal reference materials, whilst held and distributed by NIBSC were prepared by Dr David Goldblatt (Institute of Child Health, UK: see http://www.ich.ucl.ac.uk/ich/academicunits/Immunobiology/StaffList).
23. EMEA Guidance on use of bovine-derived materials http://www.emea.eu.int/ pdfs/human/bwp/TSE%20NFG%20410-rev2.pdf.
24. Ward, J.; Lieberman, J. M.; Cochi, S. L. in "Vaccines"; Plotkin S. A.; Mortimer, E. A. Eds.; W.B. Saunders and Co., Philadelphia, PA, 1994, pp 337-386.
25. Fattom, A. I.; Horwith, G.; Fuller, S.; Propst, M.; Naso, R. Vaccine, 2004, 22, 880-887.
26. Pharmacopeia of the United States of America, 28th Revision, Rockville, MD, 2005, pp 2186, 2540-2550, 2587-2607.
27. Ravenscroft, N. Pharmeuropa Spec. Issue Biol. 2000, 131-144.
28. Macnair, J. E.; Desai, T.; Teyral, J.; Abeygunawardana, C.; Hennessey, J. P. Jr. Biologicals 2005, 33, 49-58.
29. Jones, C. Carbohydr. Res. 2005, 340, 1097-1106.
30. Jones, C.; Lemercinier, X. Carbohydr. Res. 2005, 340, 403-409.
31. Xu, Q.; Klees, J.; Teyral, J.; Capen, R.; Huang, M.; Sturgess, A.W.; Hennessey, J. P. Jr; Washabaugh, M.; Sitrin, R.; Abeygunawardana, C. Anal. Biochem. 2005, 337, 235-245.
32. Jone, s C.; Lemercinier, X. J. Pharm. Biomed. Anal. 2002, 30, 1233-1247.
33. Xu, Q.; Abeygunawardana, C.; Ng, A. S.; Sturgess, A. W.; Harmon, B. J.; Hennessey, J. P. Jr. Anal. Biochem. 2005, 336, 262-272.
34. Jones, C.; Lemercinier, X.; Crane, D. T.; Gee, C. K.; Austin, S. Dev. Biol. (Basel) 2000, 103, 121-136.
35. Egan, W.; Frasch, C. E.; Anthony, B. F. JAMA 1995, 273, 888-889.
36. Berkowitz, C. D.; Ward, J. I.; Meier, K.; Hendley, J. O.; Brunell, P. A.; Barkin, R. A.; Zahradnik, J. M.; Samuelson, J.; Gordon, L., J. Pediatr. 1987, 110, 509-514.
37. Lepow, M. L.; Samuelson, J. S.; Gordon, L. K. J. Infect. Dis. 1984, 150, 402-406.
38. Richmond, P.; Goldblatt, D.; Fusco, P. C.; Fusco, J. D.; Heron, I.; Clark, S.; Borrow, R.; Michon, F. Vaccine 1999, 18, 641-646.
39. Anderson,E. L.; Bowers, T.; Mink, C. M.; Kennedy, D. J.; Belshe, R. B.; Harakeh, H.; Pais, L.; Holder, P.; Carlone, G. M. Infect. Immun. 1994, 62, 3391-3395.
40. Bruge, J.; Bouveret-Le Cam, N.; Danve, B.; Rougon, G.; Schulz, D. Vaccine 2004, 22, 1087-1096.
41. Campbell, J. D.; Edelman, R.; King, J.C. Jr; Papa, T.; Ryall, R.; Rennels, M.B. J. Infect. Dis. 2002, 186, 1848-1851.
42. Wuorimaa, T.; Käyhty, H.; Leroy, O.; Eskola, J. Vaccine 2001, 19, 1863- 1869.
43. Lepow, M. L.; Samuelson, J. S.; Gordon, L. K. J. Pediatr. 1985, 106, 185- 189.
44. Wuorimaa, T.; Dagan, R.; Eskola, J.; Janco, J.; Ahman, H.; Leroy, O.; Käyhty, H. Pediatr. Infect. Dis. J. 2001, 20, 272-277.
45. Madore, D. V.; Johnson, C. L.; Phipps, D. C.; Myers, M. G.; Eby, R.; Smith, D. H. Pediatrics 1990, 86, 527-534.
46. Vadheim, C. M.; Greenberg, D. P.; Marcy, S. M.; Froeschle, J.; Ward, J. I. Pediatr. Infect. Dis. J. 1990, 9, 555-561.
47. Käyhty, H.; Peltola, H.; Eskola, J.; Rönnberg, P. R.; Kela, E.; Karanko, V.; Mäkelä, P. H. Pediatrics 1989, 84, 995-999.
48. Granoff, D. M.; Weinberg, G. A.; Shackelford, P. G. Pediatr. Res. 1988, 24, 180-185.
49. Shinefield, H. R.; Black, S.; Ray, P.; Chang, I.; Lewis, N.; Fireman, B.; Hackell, J.; Paradiso, P. R.; Siber, G.; Kohberger, R.; Madore, D. V.; Malinowski, F. J.; Kimura, A.; Le, C.; Landaw, I.; Aguilar, J.; Hansen, J. Pediatr. Infect. Dis. J. 1999, 18, 757-763.
50. Musher D. M.; Groover J. E.; Watson D. A.; Rodriguez-Barradas M. C.; Baughn R. E. Clin. Infect. Dis. 1998, 27, 1487-90.
51. Shinefield, H. R.; Black, S. Pediatr. Infect. Dis. J. 2000, 19, 394-397.
52. Trotter, C. L.; Andrews, N. J.; Kaczmarski,E. B.; Miller, E.; Ramsay, M. E. Lancet 2004, 364, 365-367.
53. Miller, E.; Salisbury, D.; Ramsay, M. Vaccine 2001, 20, S58-S67.
54. NIH database of clinical trials: http://www.clinicaltrials.gov.
55. ICH Guidelines on specification setting for biotechnology products http://www.ich.org/MediaServer.jser?@-ID=432&@-MODE=GLB.
56. The ICH Common Technical Document http://www.ich.org/cache/compo/276-254- 1.html.
57. Jodar, L.; Butler, J.; Carlone, G.; Dagan, R.; Goldblatt, D.; Kayhty, H.; Klugman, K.; Plikyatis, B.; Siber, G.; Kohberger, R.; Chang, I.; Cherain, T. Vaccine 2003, 21, 3265-3272.
58. Lee, L. H.; Frasch, C. E.; Falk, L. A.; Klein, D. L.; Deal, C. D. Vaccine 2003, 21, 2190-2196.
59. McVernon, J.; Howard, A.J.; Slack, M. P. E.; Ramsay, M. E. Epidemiol. Infect. 2004, 132, 765-767.
60. Holliday, M. R.; Jones, C. Biologicals 1999, 27, 51-53.
61. von Hunolstein, C.; Parisi, L.; Recchia, S. Vaccine 1999, 17, 118-125.
62. Peeters, C. C. A. M.; Tenbergen-Meekes, A.-M. J.; Poolman, J. T.; Zegers, B. J. M.; Rijkers, G. T. Vaccine, 1992, 10, 833-840.
63. Sturgess, A. W.; Rush, K.; Charbonneau, R. J.; Lee, J. I.; West, D. J.; Sitrin, R. D.; Hennessy, J. P. Jr Vaccine, 1999, 17, 1169-1178.
64. Lei, Q. P; Lamb, D. H.; Shannon, A. G.; Cai, X.; Heller, R. K.; Huang, M.; Zablackis, E.; Ryall, R.; Cash, P. J. Chromatogr. Β Analyt. Technol. Biomed. Life Sci. 2004, 813, 103-112.