SCOPUS 정보 검색 플랫폼

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

Volumn , Issue , 2007, Pages 499-515

Current Practices in the Preclinical Safety Assessment of Peptides

(2) Heidel, Shawn M a Page, Todd J a

a ELI LILLY AND COMPANY (United States)

Author keywords

Carcinogenicity testing; Genetic toxicology peptides and NCEs; Peptide preclinical toxicity assessment

Indexed keywords

EID: 84891540063 PISSN: None EISSN: None Source Type: Book
DOI: 10.1002/9780470292549.ch22 Document Type: Chapter

Times cited : (1)

References (43)

1
- 0027421638
- Research, development, production, and safety of biosynthetic human insulin
- Chance RE, Frank BH. Research, development, production, and safety of biosynthetic human insulin. Diabet Care 1993; 16 (Suppl 3): 133 - 42.
- (1993) Diabet Care , vol.16 , Issue.SUPPL 3 , pp. 133-142
- Chance, R.E.¹ Frank, B.H.²

2
- 15544379805
- Watching Peptide Drugs Grow Up
- Marx V. Watching Peptide Drugs Grow Up. Chem Eng News 2005; 83 (11): 17 - 24.
- (2005) Chem Eng News , vol.83 , Issue.11 , pp. 17-24
- Marx, V.¹

3
- 84891549242
- EMEA. Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues
- EMEA. Points to consider document on the non-clinical assessment of the carcinogenic potential of insulin analogues, 2001. http://www.emea.europa.eu/pdfs/human/swp/037201en.pdf
- (2001)

4
- 84891501185
- FDA. Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis
- FDA. Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis, 2000. http://www.fda.gov/cder/guidance/3789dft.htm
- (2000)

5
- 0033093819
- Genotoxicity testing of biotechnology-derived products: report of a GUM task force
- Gocke E, Albertini S, Brendler-Schwaab S, Muller L, Suter W, Wurgler FE. Genotoxicity testing of biotechnology-derived products: report of a GUM task force. Gesellschaft fur Umweltmutationsforschung. Mutat Res 1999; 436 (2): 137 - 56.
- (1999) Gesellschaft fur Umweltmutationsforschung. Mutat Res , vol.436 , Issue.2 , pp. 137-156
- Gocke, E.¹ Albertini, S.² Brendler-Schwaab, S.³ Muller, L.⁴ Suter, W.⁵ Wurgler, F.E.⁶

6
- 84891544556
- Insulin Detemir. Summary Basis for Approval, EPAR
- Insulin Detemir. Summary Basis for Approval, EPAR, 2006. http://www.emea. europa.eu/humandocs/PDFs/EPAR/levemir/093604en6.pdf
- (2006)

7
- 84891510280
- Insulin Glulisine. Summary Basis for Approval, Pharmacology Review
- Insulin Glulisine. Summary Basis for Approval, Pharmacology Review, 2004. http:// www.fda.gov/cder/foi/nda/2004/21-629_Apidra.htm
- (2004)

8
- 84891521700
- Insulin Glulisine. Summary Basis for Approval, EPAR
- Insulin Glulisine. Summary Basis for Approval, EPAR, 2006. http://www.emea. europa.eu/humandocs/PDFs/EPAR/apidra/121804en6.pdf
- (2006)

9
- 37349045360
- Duration of chronic toxicity studies for biotechnology -derived pharmaceuticals: Is six months still appropriate ?
- Clarke J, Hurst C, M artin P, Vahle J, Ponce R, Mounho B, Heidel S, Andrews L, Reynolds T, Cavagnaro J. Duration of chronic toxicity studies for biotechnology -derived pharmaceuticals: Is six months still appropriate ? Regul Toxicol Pharmacol 2008; 50: 2 - 22.
- (2008) Regul Toxicol Pharmacol , vol.50 , pp. 2-22
- Clarke, J.¹ Hurst, C.² Martin, P.³ Vahle, J.⁴ Ponce, R.⁵ Mounho, B.⁶ Heidel, S.⁷ Andrews, L.⁸ Reynolds, T.⁹ Cavagnaro, J.¹⁰

10
- 84891549762
- Bivalrudin. Summary Basis for Approval, Pharmacology Review
- Bivalrudin. Summary Basis for Approval, Pharmacology Review, 2000. http://www. fda.gov/cder/foi/nda/2000/20873_Angiomax.htm
- (2000)

11
- 84891525077
- Bivalrudin. Summary Basis for Approval EPAR
- Bivalrudin. Summary Basis for Approval EPAR, 2004. http://www.emea.europa. eu/humandocs/PDFs/EPAR/angiox/103304en6.pdf
- (2004)

12
- 84891527545
- Eptifi batide. Summary Basis for Approval, Pharmacology Review
- Eptifi batide. Summary Basis for Approval, Pharmacology Review, 1998. http:// www.fda.gov/cder/foi/nda/98/20718_Integrilin.htm
- (1998)

13
- 84891536933
- Eptifi batide. Summary Basis of Approval, EPAR
- Eptifi batide. Summary Basis of Approval, EPAR, 2004. http://www.emea.europa. eu/humandocs/PDFs/EPAR/Integrilin/110099en6.pdf
- (2004)

14
- 0022508987
- A synthetic peptide from fi bronectin inhibits experimental metastasis of murine melanoma cells
- Humphries MJ, Olden K, Yamada KM. A synthetic peptide from fi bronectin inhibits experimental metastasis of murine melanoma cells. Science 1986; 233 (4762): 467 - 70.
- (1986) Science , vol.233 , Issue.4762 , pp. 467-470
- Humphries, M.J.¹ Olden, K.² Yamada, K.M.³

15
- 84891528110
- Enfuvirtide. Summary Basis for Approval, Pharmacology Review
- Enfuvirtide. Summary Basis for Approval, Pharmacology Review, 2003. http://www. fda.gov/cder/foi/nda/2003/021481_fuzeon_review.htm
- (2003)

16
- 84891517859
- Enfuvirtide. Summary Basis for Approval, EPAR
- Enfuvirtide. Summary Basis for Approval, EPAR, 2004. http://www.emea.europa. eu/humandocs/PDFs/EPAR/fuzeon/169503en6.pdf
- (2004)

17
- 0002891820
- Klaassen C, ed
- Pitot HC, Dragan YP, Casarett and Doull's Toxicology, 6 ed. Klaassen C, ed. 2001; 266 - 78.
- (2001) Casarett and Doull's Toxicology, 6 ed , pp. 266-278
- Pitot, H.C.¹ Dragan, Y.P.²

18
- 0036001310
- Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety
- Vahle JL, Sato M, Long GG, Young JK, Francis PC, Engelhardt JA, Westmore MS, Linda Y, Nold JB. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1 - 34) for 2 years and relevance to human safety. Toxicol Pathol 2002; 30 (3): 312 - 21.
- (2002) Toxicol Pathol , vol.30 , Issue.3 , pp. 312-321
- Vahle, J.L.¹ Sato, M.² Long, G.G.³ Young, J.K.⁴ Francis, P.C.⁵ Engelhardt, J.A.⁶ Westmore, M.S.⁷ Linda, Y.⁸ Nold, J.B.⁹

19
- 3242887547
- Bone neoplasms in F344 rats given teriparatide [rhPTH(1-34)] are dependent on duration of treatment and dose
- Vahle JL, Long GG, Sandusky G, Westmore MS, Ma YL, Sato M. Bone neoplasms in F344 rats given teriparatide [rhPTH(1 - 34)] are dependent on duration of treatment and dose. Toxicol Pathol 2004; 32 (4): 426 - 38.
- (2004) Toxicol Pathol , vol.32 , Issue.4 , pp. 426-438
- Vahle, J.L.¹ Long, G.G.² Sandusky, G.³ Westmore, M.S.⁴ Ma, Y.L.⁵ Sato, M.⁶

20
- 84891543627
- Insulin Detemir. Summary Basis for Approval, Pharmacology Review
- Insulin Detemir. Summary Basis for Approval, Pharmacology Review, 2005. http:// www.fda.gov/cder/foi/nda/2005/021-536_LevemirTOC.htm
- (2005)

21
- 0001008384
- Carcinogenic effect on female rats after 12 months administration of the insulin analogue B10 Asp
- Dideriksen LH, Jorgensin LN, Drejer K. Carcinogenic effect on female rats after 12 months administration of the insulin analogue B10 Asp. Diabetes 1992; 41: 143A.
- (1992) Diabetes , vol.41
- Dideriksen, L.H.¹ Jorgensin, L.N.² Drejer, K.³

22
- 0030614323
- ASPB10 insulin induction of increased mitogenic responses and phenotypic changes in human breast epithelial cells: evidence for enhanced interactions with the insulin-like growth factor-I receptor
- Milazzo G, Sciacca L, Papa V, Goldfi ne ID, Vigneri R. ASPB10 insulin induction of increased mitogenic responses and phenotypic changes in human breast epithelial cells: evidence for enhanced interactions with the insulin-like growth factor-I receptor. Mol Carcinog 1997; 18 (1): 19 - 25.
- (1997) Mol Carcinog , vol.18 , Issue.1 , pp. 19-25
- Milazzo, G.¹ Sciacca, L.² Papa, V.³ Goldfine, I.D.⁴ Vigneri, R.⁵

23
- 0033944662
- Assessment of immunosuppressant drug carcinogenicity: standard and alternative animal models
- Hastings KL. Assessment of immunosuppressant drug carcinogenicity: standard and alternative animal models. Hum Exp Toxicol 2000; 19 (4): 261 - 5.
- (2000) Hum Exp Toxicol , vol.19 , Issue.4 , pp. 261-265
- Hastings, K.L.¹

24
- 5744240625
- Human carcinogenic risk evaluation. Part III: Assessing cancer hazard and risk in human drug development
- Jacobs A, Jacobson-Kram D. Human carcinogenic risk evaluation. Part III: Assessing cancer hazard and risk in human drug development. Toxicol Sci 2004; 81 (2): 260 - 2.
- (2004) Toxicol Sci , vol.81 , Issue.2 , pp. 260-262
- Jacobs, A.¹ Jacobson-Kram, D.²

25
- 0033742687
- Mechanisms of nongenotoxic carcinogenesis and assessment of the human hazard
- Silva Lima B, V an der L aan JW. Mechanisms of nongenotoxic carcinogenesis and assessment of the human hazard. Regul Toxicol Pharmacol 2000; 32 (2); 135 - 43.
- (2000) Regul Toxicol Pharmacol , vol.32 , Issue.2 , pp. 135-143
- Silva Lima, B.¹ VanderLaan, J.W.²

26
- 84891535342
- Cetrorelix. Summary Basis for Approval, Pharmacology Review
- Cetrorelix. Summary Basis for Approval, Pharmacology Review, 2000. http://www. fda.gov/cder/foi/nda/2000/21-197_Cetrotide.htm
- (2000)

27
- 84891532323
- Cetrorelix. Summary Basis for Approval, EPAR
- Cetrorelix. Summary Basis for Approval, EPAR, 2003. http://www.emea.europa. eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf
- (2003)

28
- 84891546355
- Nesiritide. Summary Basis for Approval, Pharmacology Review
- Nesiritide. Summary Basis for Approval, Pharmacology Review, 2001. http://www. fda.gov/cder/foi/nda/2001/20-920_Natrecor.htm
- (2001)

29
- 84891549973
- Ziconatide. Summary Basis for Approval, Pharmacology Review
- Ziconatide. Summary Basis for Approval, Pharmacology Review, 2004. http://www. fda.gov/cder/foi/nda/2004/21-060_Prialt.htm
- (2004)

30
- 84891546967
- Ziconatide. Summary Basis for Approval, EPAR
- Ziconatide. Summary Basis for Approval, EPAR, 2006. http://www.emea.europa. eu/humandocs/PDFs/EPAR/Prialt/14122704en6.pdf
- (2006)

31
- 84891509564
- Exenatide. Summary Basis for Approval, Pharmacology
- Exenatide. Summary Basis for Approval, Pharmacology, 2005. http://www.fda.gov/ cder/foi/nda/2005/021773_ByettaTOC.htm
- (2005)

32
- 84891522834
- Exenatide. Summary Basis for Approval, EPAR
- Exenatide. Summary Basis for Approval, EPAR, 2006. http://www.emea.europa. eu/humandocs/PDFs/EPAR/byetta/H-698-en6.pdf
- (2006)

33
- 84891541758
- Leuprolide. Label
- Leuprolide. Label, 1993. http://www.fda.gov/cder/foi/label/2004/20263slr024_ lupron_lbl.pdf
- (1993)

34
- 84891513870
- Calcitonin. Summary Basis of Approval, EPAR
- Calcitonin. Summary Basis of Approval, EPAR, 1999. http://www.emea.europa.eu/ humandocs/PDFs/EPAR/Forcaltonin/238798en6.pdf
- (1999)

35
- 84891538497
- Calcitonin. Label
- Calcitonin. Label, 2005. http://www.fda.gov/cder/foi/label/2005/021406lbl.pdf
- (2005)

36
- 84891504122
- Octreotide. Label
- Octreotide. Label, 2005. http://www.fda.gov/cder/foi/label/2005/019667s050lbl.pdf
- (2005)

37
- 84891517999
- Forsteo. Summary Basis For Approval, EPAR
- Forsteo. Summary Basis For Approval, EPAR, 2004. http://www.emea.europa.eu/ humandocs/PDFs/EPAR/forsteo/659802en6.pdf
- (2004)

38
- 84891520894
- Forteo. Summary Basis For Approval, Pharmacology Review
- Forteo. Summary Basis For Approval, Pharmacology Review, 2002. http://www.fda. gov/cder/foi/nda/2002/21-318_FORTEO_Pharmr_P1.pdf
- (2002)

39
- 84891545124
- Insulin Lispro. Summary Basis for Approval, EPAR
- Insulin Lispro. Summary Basis for Approval, EPAR, 2004. http://www.emea.europa. eu/humandocs/PDFs/EPAR/Humalog/060195en6.pdf
- (2004)

40
- 84891498603
- Insulin Glargine. Summary Basis for Approval, Pharmacology Review
- Insulin Glargine. Summary Basis for Approval, Pharmacology Review, 2000. http:// www.fda.gov/cder/foi/nda/2000/21081_Lantus.htm
- (2000)

41
- 84891503865
- Insulin Glargine. Summary Basis for Approval, EPAR
- Insulin Glargine. Summary Basis for Approval, EPAR, 2003. http://www.emea. europa.eu/humandocs/PDFs/EPAR/Lantus/061500en6.pdf
- (2003)

42
- 84891499628
- Insulin Aspart. Summary Basis for Approval, Pharmacology Review
- Insulin Aspart. Summary Basis for Approval, Pharmacology Review, 2000. http:// www.fda.gov/cder/foi/nda/2000/20-986_NovoLog.htm
- (2000)

43
- 84891525903
- Insulin Aspart. Summary Basis for Approval, EPAR
- Insulin Aspart. Summary Basis for Approval, EPAR, 2004. http://www.emea. europa.eu/humandocs/PDFs/EPAR/Novorapid/272799en6.pdf
- (2004)

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.