Design of biological equivalence programs for therapeutic biotechnology products in clinical development: A perspective

Pharmaceutical Research

Volumn 13, Issue 10, 1996, Pages 1427-1437

  Mordenti, Joyce ^a   Cavagnaro, Joy A ^b   Green, James D ^a  

^a GENENTECH INC   (United States)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Bioequivalence; Biotechnology products; Efficacy; Immunogenicity; Pharmacodynamics; Pharmacokinetics; Recombinant proteins; Safety

Indexed keywords

HUMAN GROWTH HORMONE; SOMATOMEDIN C;

ANIMAL EXPERIMENT; BIOEQUIVALENCE; DRUG ACTIVITY; DRUG ANALYSIS; DRUG DEVELOPMENT; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INTRAVENOUS DRUG ADMINISTRATION; METHODOLOGY; MONKEY; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; RAT; RECOMBINANT DNA TECHNOLOGY; SHORT SURVEY; SUBCUTANEOUS DRUG ADMINISTRATION;

BIOTECHNOLOGY; CLINICAL TRIALS; DRUG DESIGN; HUMANS; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 0029859232     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1016002823485     Document Type: Short Survey

References (59)

1. J. D. Green. In P. F. D'Arcy and D. W. G. Harron (eds.) Proceedings of the Third International Conference on Harmonization, Yokohama, 1995, Queen's University of Belfast Press, Northern Ireland, 1996, pp. 230-236.
2. R. Williams. (abstract). Bio-International '92. Conference on Bioavailability, Bioequivalence and Pharmacokinetic studies.
3. L. Z. Benet. In K. Midha and H. Blume (eds.), Bio-International. Bioavailability, bioequivalence, and Pharmacokinetics. Medpharm, Stuttgart, 1993. pp. 27-37.
4. V. Steinijans, D. Hauschke, and H. Jonkman. Clin. Pharmacokinet. 22:247-253 (1992).
5. H. Blume and K. Midha. Pharm. Res. 10:1806-1811 (1993).
6. Proceedings of the FDA bioequivalence hearings, Docket number 86N-0251, Washington, DC., September 29-October 1, 1986.
7. Report by the bioequivalence task force on recommendations from the bioequivalence hearings conducted by the Food and Drug Administration, 86N-0251, RPT00002, pp. 19-21, January 1988.
8. H. Blume and K. Midha (eds.). Bio-International 2. Bioavailability, Bioequivalence, and Pharmacokinetic Studies. Medpharm, Stuttgart, 1995.
9. A. Supersaxo, W. Hein, H. Gallati, and H. Steffen. Pharm. Res. 5:472-476 (1988).
10. A. Supersaxo, W. Hein, H. and Steffen. Pharm. Res. 7:167-169 (1990).
11. J. Kahn, J. D. Allan, T. Hodges, L. Kaplan, C. Arri, H. Fitch, A. Izu, J. Mordenti, S. Sherwin, J. Groopman, and P. Volberding. Annals of Internal Medicine 112:254-261 (1990).
12. W. Saal, H-J. Glowania, W. Hengst, and J. Happ. Fertility and Sterility 56:225-229 (1991).
13. J. Mordenti, S. A. Chen, and B. Ferraiolo. In A. H. C. Kung, R. A. Baughman, and J. W. Larrick (eds.), Protein Therapeutics: Pharmacokinetics and Pharmacodynamics., W. H. Freeman and company, New York, 1993, pp. 187-199.
14. S. Beshyah, V. Anyaoku, R. Niththyananthan, P. Sharp, and D. Johnston. Clin. Endocrinol. 35:409-112 (1991).
15. T. Laursen, J. Jorgensen, and J. Christiansen. Clin. Endocrinol. 40:373-378 (1994).
16. S. Blunt, R. Clayton, and W. Butt. Clinical Endocrinology 25:589-596 (1986).
17. P. Hildebrandt, L. Sestoft, and S. Nielsen. Diabetes Care 6:459-462 (1983).
18. J. Thow and P. Home. Br. Med. Journal 301:3-4 (1990).
19. H. Kirchner, A. Korfer, P. Evers, M. M. Szamel, J. Knuver-Hopf, H. Mohr, C. R. Franks, U. Pohl, K. Resch, M. Hadam, H. Poliwoda, and J. Atzpodien. Cancer 67:1862-1864 (1991).
20. K. Lundin, L. Berger, F. Blomberg, and P. Wilton. Acta Paediatr. Scand. (suppl), 372:167-168 (1991).
21. C. M. Zwickl, K. S. Cocke, R. N. Tamura, L. M. Holzhausen, G. T. Brophy, P. H. Bick, and D. Wierda. Fundamental and Applied Toxicology 16:275-287 (1991).
22. R. Dillman. Antibody Immunoconj. Radiopharm. 3:1-15, (1990).
23. E. Muchmore, M. Milewski, A. Varki, and S. Diaz. J. Biol. Chem. 264:20216-20223 (1989).
24. Y. Kozutsumi, T. Kawano, H. Kawasaki, K. Suzuki, T. Yamakawa, and A. Suzuki. J. Biochem. 110:429-435 (1991).
25. V. Shah, K. Midha, S. Dighe, I. McGilveray, J. Skelly, A. Yacobi, T. Layloff, C. Viswanathan, C. E. Cook, R. McDowall, K. Pittman, and S. Spector. Pharm. Res. 9:588-592 (1992).
26. L. Boscato and M. Stuart. Clin. Chem. 34:27-33 (1988).
27. T. Weber, K. Kapyaho, and P. Tanner, Scand. J. Clin. Lab. Invest. 50, Suppl 201:77-82 (1990).
28. A. Chen, D. Baker, and B. Ferraiolo. In P. Garzone, W. Colburn, and M. Mokotoff (eds.), Peptides, Peptoids, and Proteins. Harvey Whitney Books, Cincinnati, OH, 1991, pp. 54-71.
29. D. Eaton, P. Hass, L. Riddle, J. Mather, M. Wiebe, T. Gregory, and G. Vehar. J. Bio. Chem. 262:3285-90 (1987).
30. R. Baughman, Jr. In B. Sobel, D. Collen, E. Grossbard (eds.) Tissue Plasminogen Activator in Thrombolytic Therapy, Marcel Dekker, Inc., New York, 1987, pp. 41-53.
31. S. Gauny, J. Andya, J. Thomson, J. Young, and J. Winkelhake. Hum. Antibod. Hybridomas 2:33-38 (1991).
32. G. Ashwell and A. Morell. In A. Meister (ed.) Advances in Enzymology and Related Areas of Molecular Biology, John Wiley and Sons, New York, 1974, pp. 99-128.
33. G. Ashwell and J. Harford. Ann. Rev. Biochem. 51:531-54 (1982).
34. D. Barbeau. Controlled Release Newsletter, Controlled Release Society, Inc., Deerfield, IL, July 1990, pp. 6-8.
35. M. Fukuda, H. Sasaki, L. Lopez, and M. Fukuda. Blood 73:84-89 (1989).
36. W. Blum and D. Gupta. J. Endocr. 105:29-37 (1985).
37. T. Sareneva, K. Cantell, L. Pyhala, J. Pirhonen, and I. Julkunen. J. Interferon Res. 13:267-269 (1993).
38. J. Henkin, D. Dudlak, D. Beebe, and L. Sennello. Thrombosis Research 63:215-225 (1991).
39. M. Mattes. J. Nat. Cancer Inst. 79:855-863 (1987).
40. M. Manning, K. Patel, and R. Borchardt. Pharm. Res. 6:903-917 (1989).
41. J. Cleland, M. Powell, and S. Shire. Crit. Rev. Therap. Drug Carrier Systems 10:3007-377 (1993).
42. S. Li, C. Schoneich, and R. Borchardt. Biotech. and Bioengineer. 48:490-500 (1995b).
43. C. Schmelzer, L. Burton, W.-P. Chan, E. Martin, C. Gorman, E. Canova-Davis, V. Ling, M. Slikowski, G. McCray, J. Briggs, T. Nguyen, and G. Polastri. J. Neurochem. 59:1675-1683, (1992).
44. C. Drinkwater, P. Barker, U. Suter, and E. Shooter. J. Biol. Chem. 268:23202-207 (1993).
45. A. Shih, G. Laramee, C. Schmelzer, L. Burton, and J. Winslow. J. Biol. Chem. 269:27679-686 (1994).
46. R. Baxter and J. Martin. Biochem. Biophys. Res. Commun. 147:408-415 (1987).
47. A. Lord, S. Bastian, L. Read, P. Walton, and F. Ballard. J. Endocrin. 140:475-482 (1994).
48. A. Rescigno. Pharm. Res. 9:925-928 (1992).
49. W. Hauck and S. Anderson. J. Pharmacokin. Biopharm. 22:551-564 (1994).
50. S. Chen, A. Izu, J. Mordenti, and A. Rescigno. Am. J. Therapeutics 2:190-195 (1995).
51. A. L. Gould. J. Pharmacokin. Biopharm. 23:57-86 (1995).
52. L. Endrenyi and P. Al-Shaikh. Pharm. Res. 12:1856-1864 (1995)
53. A. W. Boddy, F. C. Snikeris, R. O. Kringle, G. C. G. Wei, J. A. Oppermann, and K. K. Midha. Pharm. Res. 12:1865-1868 (1995).
54. R. P. Basson, B. J. Cerimele, K. A. DeSante, and D. C. Howey. Pharm. Res. 13:324-328 (1996).
55. T. N. Tozer, F. Y. Bois, W. W. Hauck, M. L. Chen, and R. L. Williams. Pharm. Res. 13:453-456 (1996).
56. R. G. Buice, V. S. Subramanian, K. L. Duchin, and S. Uko-Nne. Pharm. Res. 13: 1109-1115 (1996).
57. H. S. Pentikis, J. D. Henderson, N. L. Tran, and T. M. Ludden. Pharm. Res. 13: 1116-1121 (1996).
58. R. Schall and R. Williams. J. Pharmacokin. Biopharm. 24:133-149 (1996).
59. L. Z. Benet and J. E. Goyan. Pharmacotherapy 15:433-440 (1995).