Pharmaceutical Manufacturing Handbook: Production and

30 BIOTECHNOLOGY-DERIVED DRUG PRODUCT DEVELOPMENT
17. Knudsen , L. B. , Nielsen , P. F. , Huusfeldt , P. O. , Johansen , N. L. , Madsen , K. , Pedersen ,
F. Z. , Thogersen , H. , Wilken , M. , and Agerso , H. ( 2000 ), Potent derivatives of glucagon -
like peptide - 1 with pharmacokinetic properties suitable for once daily administration , J.
Med. Chem. , 43 , 1664 – 1669 .
18. Foldvari , M. , Attah - Poku , S. , Hu , J. , Li , Q. , Hughes , H. , Babiuk , L. A. , and Kruger , S. ( 1998 ),
Palmitoyl derivatives of interferon α : Potential for cutaneous delivery , J. Pharm. Sci. , 87 ,
1203 – 1208 .
19. Egrie , J.C. , and Browne , J. K. ( 2001 ), Development and characterization of novel erythropoiesis
stimulating protein (NESP) , Nephrol. Dial. Transplant. , 16 (Suppl 3 ), 3 – 13 .
20. Haselbeck , A. ( 2003 ), Epoetins: Differences and their relevance to immunogenicity , Curr.
Med. Res. Opin. , 19 , 430 – 432 .
21. Hochuli , E. ( 1997 ), Interferon immunogenicity: Technical evaluation of interferon -α 2A ,
J. Int. Cytokine Res. , 17 , S15 – S21 .
22. Maack , T. , Johnson , V. , Kau , S. T. , Figueiredo , J. , and Sigulem , D. ( 1979 ), Renal fi ltration,
transport, and metabolism of low - molecular - weight proteins: A review , Kidney Int. , 16 ,
251 – 270 .
23. Takagi , A. , Masuda , H. , Takakura , Y. , and Hashida , M. ( 1995 ), Disposition characteristics
of recombinant human interleukin - 11 after a bolus intravenous administration in mice ,
J. Pharmacol. Exp. Ther. , 275 , 537 – 543 .
24. Anderson , P. M. , and Sorenson , M. A. ( 1994 ), Effects of route and formulation on clinical
pharmacokinetics of interleukin - 2 , Clin. Pharmacokinet. , 27 , 19 – 31 .
25. Rabkin , R. , Ryan , M. P. , and Duckworth , W. C. ( 1984 ), The renal metabolism of insulin ,
Diabetologia , 27 , 351 – 357 .
26. Johnson , V. , and Maack , T. ( 1977 ), Renal extraction, fi ltration, absorption, and catabolism
of growth hormone , Am. J. Phsiol. , 233 , F185 – F196 .
27. Carone , F. A. , and Peterson , D. R. ( 1980 ), Hydrolysis and transport of small peptides by
the proximal tubule , Am. J. Physiol. , 238 , F151 – F158 .
28. Carone , F. A. , Peterson , D. R. , and Flouret , G. ( 1982 ), Renal tubular processing of small
peptide hormones , J. Lab. Clin. Med. , 100 , 1 – 14 .
29. Braeckman , R. ( 2000 ), Pharmacokinetics and pharmacodynamics of protein therapeutics ,
in Reid , R. , Ed., Peptide and Protein Drug Analysis , Marcel Dekker , New York .
30. Meissner , H. C. , Groothuis , J. R. , Rodriguez , W. J. , Welliver , R. C. , Hogg , G. , Gray , P. H. ,
Loh , R. , Simoes , E. A. , Sly , P. , Miller , A. K. , Nichols , A. I. , Jorkasky , D. K. , Everitt , D. E. ,
and Thompson , K. A. ( 1999 ), Safety and pharmacokinetics of an intramuscular
monoclonal antibody (SB 209763) against respiratory syncytial virus (RSV) in infants
and young children at risk for severe RSV disease , Antimicrob. Agent Chemother. , 43 ,
1183 – 1188 .
31. Prescribing information for Lupron Depot ® . Manufactured for TAP Pharmaceuticals,
Inc., Lake Forest, IL 60045.
32. Prescribing information for Viadur ® . Manufactured by Alza Corporation, Mountain
View, CA 94043.
33. Degim , I. T. , and Celebi , N. ( 2007 ), Controlled delivery of peptides and proteins , Curr.
Pharm. Des. , 13 , 99 – 117 .
34. Sylvester , R. K. ( 2002 ), Clinical applications of colony - stimulating factors: A historical
perspective , Am. J. Health - Syst. Pharm. , 59 , s6 – s12 .
35. Dorr , R. T. ( 1993 ), Clinical properties of yeast - derived versus Escherichia coli - derived
granulocyte - macrophage colony - stimulating factor , Clin. Ther. , 15 , 19 – 29 .
36. Jenkins , N. , Shah , P. M. , and Buckberry , L. D. ( 2000 ), Carbohydrate analysis of glycoproteins
and glycopeptides , in Reid , R. , Ed., Protein and Peptide Drug Analysis , Marcel
Dekker , New York .