메뉴 건너뛰기




Volumn 11, Issue 1, 2005, Pages 25-31

Optimisation of pyrogen testing in parenterals according to different pharmacopoeias by probabilistic modelling

Author keywords

Animal model; Animal welfare; Pharmacopoeias; Pyrogens; Statistical model

Indexed keywords

ENDOTOXIN; PYROGEN;

EID: 17344362447     PISSN: 09680519     EISSN: None     Source Type: Journal    
DOI: 10.1179/096805105225006678     Document Type: Article
Times cited : (23)

References (26)
  • 1
    • 0030848065 scopus 로고    scopus 로고
    • Second international standard for endotoxin: Calibration in an international collaborative study
    • Poole S, Dawson P, Gaines Das RE. Second international standard for endotoxin: calibration in an international collaborative study. J Endotoxin Res 1997; 4: 221-231.
    • (1997) J. Endotoxin. Res. , vol.4 , pp. 221-231
    • Poole, S.1    Dawson, P.2    Gaines Das, R.E.3
  • 2
    • 0024559189 scopus 로고
    • The International Standard for Endotoxin: Evaluation in an international collaborative study
    • Poole S, Mussett MV. The International Standard for Endotoxin: evaluation in an international collaborative study. J Biol Stand 1989; 17: 161-171.
    • (1989) J. Biol. Stand. , vol.17 , pp. 161-171
    • Poole, S.1    Mussett, M.V.2
  • 3
    • 0020018211 scopus 로고
    • The activity of various endotoxins in the USP rabbit test and in three different LAL tests
    • Weary M, Pearson III FC, Bohon J, Donohue G. The activity of various endotoxins in the USP rabbit test and in three different LAL tests. Proc Clin Biol Res 1982; 93: 365-379.
    • (1982) Proc. Clin. Biol. Res. , vol.93 , pp. 365-379
    • Weary, M.1    Pearson III, F.C.2    Bohon, J.3    Donohue, G.4
  • 4
    • 0018410006 scopus 로고
    • Limulus amebocyte lysate (LAL) test for detecting pyrogens in parenteral injectable products and medical devices: Advantages to manufacturers and regulatory officials
    • Mascoli CC, Weary ME. Limulus amebocyte lysate (LAL) test for detecting pyrogens in parenteral injectable products and medical devices: advantages to manufacturers and regulatory officials. J Parenter Drug Assoc 1979; 33: 81-95.
    • (1979) J. Parenter. Drug Assoc. , vol.33 , pp. 81-95
    • Mascoli, C.C.1    Weary, M.E.2
  • 5
    • 0018716219 scopus 로고
    • Applications and advantages of the Limulus amebocyte lysate (LAL) pyrogen test for parenteral injectable products
    • Mascoli CC, Weary ME. Applications and advantages of the Limulus amebocyte lysate (LAL) pyrogen test for parenteral injectable products. Proc Clin Biol Res 1979; 29: 387-402.
    • (1979) Proc. Clin. Biol. Res. , vol.29 , pp. 387-402
    • Mascoli, C.C.1    Weary, M.E.2
  • 6
    • 17344362756 scopus 로고    scopus 로고
    • The United States Pharmacopeial Convention I. Biological Test - Pyrogen Test
    • Rockville, MD
    • The United States Pharmacopeial Convention I. Biological Test - Pyrogen Test. The United States Pharmacopoeia 24, Rockville, MD: 2000.
    • (2000) The United States Pharmacopoeia 24
  • 7
    • 17344364597 scopus 로고    scopus 로고
    • Biological Tests, 2.6.8 Pyrogens
    • Council of Europe. Strasbourg: Council of Europe
    • Council of Europe. Biological Tests, 2.6.8 Pyrogens. In: European Pharmacopoeia. Strasbourg: Council of Europe, 2001.
    • (2001) European Pharmacopoeia
  • 8
    • 17344366949 scopus 로고    scopus 로고
    • General Tests, Pyrogen Test
    • Society of Japanese Pharmacopoeia. (English version). Tokyo
    • Society of Japanese Pharmacopoeia. General Tests, Pyrogen Test. The Japanese Pharmacopoeia (English version). Tokyo: 1996.
    • (1996) The Japanese Pharmacopoeia
  • 10
    • 10744219738 scopus 로고    scopus 로고
    • A strategy to reduce the numbers of fish used in acute ecotoxicity testing of pharmaceuticals
    • Hutchinson TH, Barrett S, Buzby M et al. A strategy to reduce the numbers of fish used in acute ecotoxicity testing of pharmaceuticals. Environ Toxicol Chem 2003; 22: 3031-3036.
    • (2003) Environ. Toxicol. Chem. , vol.22 , pp. 3031-3036
    • Hutchinson, T.H.1    Barrett, S.2    Buzby, M.3
  • 11
    • 4444338411 scopus 로고    scopus 로고
    • Statistical evaluation of an acute dermal toxicity test using the dermal fixed dose procedure
    • Stallard N, Whitehead A, Indans I. Statistical evaluation of an acute dermal toxicity test using the dermal fixed dose procedure. Hum Exp Toxicol 2004; 23: 405-412.
    • (2004) Hum. Exp. Toxicol. , vol.23 , pp. 405-412
    • Stallard, N.1    Whitehead, A.2    Indans, I.3
  • 12
    • 0346147019 scopus 로고    scopus 로고
    • Statistical evaluation of the fixed concentration procedure for acute inhalation toxicity assessment
    • Stallard N, Whitehead A, Indans I. Statistical evaluation of the fixed concentration procedure for acute inhalation toxicity assessment. Hum Exp Toxicol 2003; 22: 575-585.
    • (2003) Hum. Exp. Toxicol. , vol.22 , pp. 575-585
    • Stallard, N.1    Whitehead, A.2    Indans, I.3
  • 13
    • 0032419361 scopus 로고    scopus 로고
    • The dermal acute toxic class method: Test procedures and biometric evaluations
    • Diener W, Kayser D, Schlede E. The dermal acute toxic class method: test procedures and biometric evaluations. Arch Toxicol 1998; 72: 751-762.
    • (1998) Arch. Toxicol. , vol.72 , pp. 751-762
    • Diener, W.1    Kayser, D.2    Schlede, E.3
  • 15
    • 0028865605 scopus 로고
    • The international validation study of the acute toxic class method (oral)
    • Schlede E, Mischke U, Diener W, Kayser D. The international validation study of the acute toxic class method (oral). Arch Toxicol 1995; 69: 659-670.
    • (1995) Arch. Toxicol. , vol.69 , pp. 659-670
    • Schlede, E.1    Mischke, U.2    Diener, W.3    Kayser, D.4
  • 16
    • 0023160882 scopus 로고
    • A confirmatory study of the up-and-down method for acute oral toxicity testing
    • Bruce RD. A confirmatory study of the up-and-down method for acute oral toxicity testing. Fundam Appl Toxicol 1987; 8: 97-100.
    • (1987) Fundam. Appl. Toxicol. , vol.8 , pp. 97-100
    • Bruce, R.D.1
  • 18
    • 0034996349 scopus 로고    scopus 로고
    • Novel pyrogen tests based on the human fever reaction
    • The report and recommendations of ECVAM Workshop 43. European Centre for the Validation of Alternative Methods. European Centre for the Validation of Alternative Methods
    • Hartung T, Aaberge I, Berthold S et al. Novel pyrogen tests based on the human fever reaction. The report and recommendations of ECVAM Workshop 43. European Centre for the Validation of Alternative Methods. European Centre for the Validation of Alternative Methods. Altern Lab Anim 2001; 29: 99-123.
    • (2001) Altern. Lab. Anim. , vol.29 , pp. 99-123
    • Hartung, T.1    Aaberge, I.2    Berthold, S.3
  • 19
    • 0019208781 scopus 로고
    • Pyrogenicity of E. coli O55:b5 endotoxin by the USP rabbit test - A HIMA collaborative study
    • Dabbah R, Ferry Jr E, Gunther DA et al. Pyrogenicity of E. coli O55:b5 endotoxin by the USP rabbit test - a HIMA collaborative study. J Parenter Drug Assoc 1980; 34: 212-216.
    • (1980) J. Parenter. Drug Assoc. , vol.34 , pp. 212-216
    • Dabbah, R.1    Ferry Jr., E.2    Gunther, D.A.3
  • 20
    • 17344366621 scopus 로고    scopus 로고
    • General Texts, 5.8. Pharmacopoeial Harmonisation
    • Council of Europe. Strasbourg: Council of Europe
    • Council of Europe. General Texts, 5.8. Pharmacopoeial Harmonisation. In: European Pharmacopoeia. Strasbourg: Council of Europe, 2001.
    • (2001) European Pharmacopoeia
  • 21
    • 0021750018 scopus 로고
    • Endotoxin contamination of parenteral drugs and radiopharmaceuticals as determined by the Limulus amebocyte lysate method
    • Twohy CW, Duran AP, Munson TE. Endotoxin contamination of parenteral drugs and radiopharmaceuticals as determined by the Limulus amebocyte lysate method. J Parenter Sci Technol 1984; 38: 190-201.
    • (1984) J. Parenter. Sci. Technol. , vol.38 , pp. 190-201
    • Twohy, C.W.1    Duran, A.P.2    Munson, T.E.3
  • 25
    • 17344363481 scopus 로고    scopus 로고
    • OECD. Environmental Health and Safety Monograph Series on Testing and Assessment No. 24. Paris: Organisation for Economic Cooperation and Development
    • OECD. Guidance Document on Acute Oral Toxicity Testing. 1-24. Environmental Health and Safety Monograph Series on Testing and Assessment No. 24. Paris: Organisation for Economic Cooperation and Development, 2001.
    • (2001) Guidance Document on Acute Oral Toxicity Testing , pp. 1-24
  • 26
    • 0037783952 scopus 로고    scopus 로고
    • Comparison of temperature rise interpretations between European and United States Pharmacopeias' pyrogen tests
    • Tschumi J. Comparison of temperature rise interpretations between European and United States Pharmacopeias' pyrogen tests. PDA J Pharm Sci Technol 2003; 57: 218-227.
    • (2003) PDA J. Pharm. Sci. Technol. , vol.57 , pp. 218-227
    • Tschumi, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.