메뉴 건너뛰기




Volumn 86, Issue 6, 2009, Pages 437-445

Pre- and postnatal developmental toxicity study design for pharmaceuticals

Author keywords

Hazard assessment; Neonatal development; Postnatal developmental toxicity; Prenatal; Safety assessment

Indexed keywords

BIRTH; BODY WEIGHT; DRUG INDUSTRY; EMBRYOTOXICITY; FERTILITY; FOOD INTAKE; GENITAL SYSTEM; HAZARD ASSESSMENT; LACTATION; LEARNING; LIBIDO; MEMORY; MOTOR ACTIVITY; NONHUMAN; POSTNATAL DEVELOPMENT; PRENATAL DEVELOPMENT; PRIORITY JOURNAL; REVIEW; SEXUAL DEVELOPMENT; TERATOGENICITY; TOXICOKINETICS; TOXICOLOGY;

EID: 73649109536     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20217     Document Type: Review
Times cited : (30)

References (24)
  • 1
    • 26844464832 scopus 로고    scopus 로고
    • The rationale for culling of rodent litters
    • Agnish ND, Keller KA. 1997. The rationale for culling of rodent litters. Fundam Appl Toxicol 38:2-6.
    • (1997) Fundam Appl Toxicol , vol.38 , pp. 2-6
    • Agnish, N.D.1    Keller, K.A.2
  • 3
    • 67650821940 scopus 로고    scopus 로고
    • Reproductive toxicity testing for pharmaceuticals under ICH
    • Barrow PC. 2009. Reproductive toxicity testing for pharmaceuticals under ICH. Reprod Toxicol 28:172-179.
    • (2009) Reprod Toxicol , vol.28 , pp. 172-179
    • Barrow, P.C.1
  • 5
    • 73649097644 scopus 로고    scopus 로고
    • Christian MS, Hoberman AM. 1997. Perspectives on the U.S., EEC, and Japanese developmental toxicity guidelines. In: Hood RD, editor. Handbook of developmental toxicology. Boca Raton, FL: CRC Press, p 551-595.
    • Christian MS, Hoberman AM. 1997. Perspectives on the U.S., EEC, and Japanese developmental toxicity guidelines. In: Hood RD, editor. Handbook of developmental toxicology. Boca Raton, FL: CRC Press, p 551-595.
  • 7
    • 0002114225 scopus 로고    scopus 로고
    • Endpoints of reproductive system development
    • Daston G, Kimmel C, editors, Washington, DC: International Life Sciences Institute Press. p
    • Clark RL. 1999. Endpoints of reproductive system development. In: Daston G, Kimmel C, editors. An evaluation and interpretation of reproductive endpoints for human health risk assessment. Washington, DC: International Life Sciences Institute Press. p 10-21.
    • (1999) An evaluation and interpretation of reproductive endpoints for human health risk assessment , pp. 10-21
    • Clark, R.L.1
  • 8
    • 45849132610 scopus 로고    scopus 로고
    • Undertaking positive control studies as part of developmental neurotoxicity testing: A report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints
    • Crofton KM, Foss JA, Hass U, Jensen KF, Levin ED, Parker SP. 2008. Undertaking positive control studies as part of developmental neurotoxicity testing: a report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints. Neurotoxicol Teratol 30:266-287.
    • (2008) Neurotoxicol Teratol , vol.30 , pp. 266-287
    • Crofton, K.M.1    Foss, J.A.2    Hass, U.3    Jensen, K.F.4    Levin, E.D.5    Parker, S.P.6
  • 9
    • 73649083408 scopus 로고    scopus 로고
    • An elegant study design to generate juvenile animal data early in drug development: Current experiences
    • De Schaepdrijver L, Bailey GP. 2005. An elegant study design to generate juvenile animal data early in drug development: current experiences. Reprod Tox 20:481.
    • (2005) Reprod Tox , vol.20 , pp. 481
    • De Schaepdrijver, L.1    Bailey, G.P.2
  • 10
    • 0019993582 scopus 로고
    • A neuromuscular screen for use in industrial toxicology
    • Gad SC. 1982. A neuromuscular screen for use in industrial toxicology. J Toxicol Environ Health 9:691-704.
    • (1982) J Toxicol Environ Health , vol.9 , pp. 691-704
    • Gad, S.C.1
  • 11
    • 0017877742 scopus 로고
    • The development of swimming behavior in mice as a behavior test in toxicology
    • Klaus S,Hacker E. 1978. The development of swimming behavior in mice as a behavior test in toxicology. Z Versuchtriek 20:81-87.
    • (1978) Z Versuchtriek , vol.20 , pp. 81-87
    • Klaus, S.1    Hacker, E.2
  • 12
    • 0017622991 scopus 로고
    • Preputial separation as an external sign of pubertal development in the male rat
    • Korenbrot CC, Huhtaniemi IT, Weiner RW. 1977. Preputial separation as an external sign of pubertal development in the male rat. Biol Reprod 17:298-303.
    • (1977) Biol Reprod , vol.17 , pp. 298-303
    • Korenbrot, C.C.1    Huhtaniemi, I.T.2    Weiner, R.W.3
  • 13
    • 67649253050 scopus 로고    scopus 로고
    • Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals
    • Martin PL, Breslin W, Rocca M, Wright D, Cavagnaro J. 2009. Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals. Birth Defects Res (Part B) 86:176-203.
    • (2009) Birth Defects Res (Part B) , vol.86 , pp. 176-203
    • Martin, P.L.1    Breslin, W.2    Rocca, M.3    Wright, D.4    Cavagnaro, J.5
  • 14
    • 0034894623 scopus 로고    scopus 로고
    • Androgen-mediated development in male rat offspring exposed to flutamide in utero: Permanence and correlation of early postnatal changes in anogenital distance and nipple retention with malformations in androgendependent tissues
    • McIntyre BS, Barlow NJ, Foster PMD. 2001. Androgen-mediated development in male rat offspring exposed to flutamide in utero: permanence and correlation of early postnatal changes in anogenital distance and nipple retention with malformations in androgendependent tissues. Toxicol Sci 62:236-249.
    • (2001) Toxicol Sci , vol.62 , pp. 236-249
    • McIntyre, B.S.1    Barlow, N.J.2    Foster, P.M.D.3
  • 15
    • 0018591165 scopus 로고
    • A method for the routine assessment of fore- and hindlimb grip strength of rats and mice
    • Meyer OA, Tilson HA, Byrd WC, Riley MT. 1979. A method for the routine assessment of fore- and hindlimb grip strength of rats and mice. Neurobehav Toxicol 1:233-236.
    • (1979) Neurobehav Toxicol , vol.1 , pp. 233-236
    • Meyer, O.A.1    Tilson, H.A.2    Byrd, W.C.3    Riley, M.T.4
  • 16
    • 0021173996 scopus 로고
    • Developments of a water-maze procedure for studying spatial learning in the rat
    • Morris R. 1984. Developments of a water-maze procedure for studying spatial learning in the rat. Neurol Sci Methods 11:47-60.
    • (1984) Neurol Sci Methods , vol.11 , pp. 47-60
    • Morris, R.1
  • 17
    • 0025935621 scopus 로고
    • Rat strain and stock comparisons using a functional observational battery: Baseline values and effects of amitraz
    • Moser VC, McDaniel KM, Philips PM. 1991. Rat strain and stock comparisons using a functional observational battery: baseline values and effects of amitraz. Toxicol Appl Pharmacol 108:267-283.
    • (1991) Toxicol Appl Pharmacol , vol.108 , pp. 267-283
    • Moser, V.C.1    McDaniel, K.M.2    Philips, P.M.3
  • 20
    • 45849083909 scopus 로고    scopus 로고
    • Identification and interpretation of developmental neurotoxicity: A report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints
    • Tyl RW, Crofton K, Moretto A, Moser V, Sheets JP, Sobotka TJ. 2008. Identification and interpretation of developmental neurotoxicity: a report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints. Neurotoxicol Teratol 30:349-381.
    • (2008) Neurotoxicol Teratol , vol.30 , pp. 349-381
    • Tyl, R.W.1    Crofton, K.2    Moretto, A.3    Moser, V.4    Sheets, J.P.5    Sobotka, T.J.6
  • 21
    • 0023553505 scopus 로고
    • Maze learning in rats: A comparison of performance in two water mazes in progeny pre-natally exposed to different doses of phenytoin
    • Vorhees CV. 1987. Maze learning in rats: A comparison of performance in two water mazes in progeny pre-natally exposed to different doses of phenytoin. Neurotoxicol Teratol 9:235-241.
    • (1987) Neurotoxicol Teratol , vol.9 , pp. 235-241
    • Vorhees, C.V.1
  • 22
    • 73649108958 scopus 로고
    • Validity of the Biel water maze for detecting developmentally induced learning impairments
    • Vorhees CV. 1990. Validity of the Biel water maze for detecting developmentally induced learning impairments. Neurotoxicol Teratol 12:567.
    • (1990) Neurotoxicol Teratol , vol.12 , pp. 567
    • Vorhees, C.V.1
  • 23
    • 0031267185 scopus 로고    scopus 로고
    • Methods for detecting long-term CNS dysfunction after prenatal exposure to neurotoxins
    • Vorhees CV. 1997. Methods for detecting long-term CNS dysfunction after prenatal exposure to neurotoxins. Drug Chem Toxicol 20:387-399.
    • (1997) Drug Chem Toxicol , vol.20 , pp. 387-399
    • Vorhees, C.V.1
  • 24
    • 73649110666 scopus 로고    scopus 로고
    • Use of toxicokinetics in developmental and reproductive toxicology
    • Hood RD, editor, New York: CRL Press, Inc. p
    • Wier P. 2006. Use of toxicokinetics in developmental and reproductive toxicology. In: Hood RD, editor. Handbook of developmental toxicology. New York: CRL Press, Inc. p 571-597.
    • (2006) Handbook of developmental toxicology , pp. 571-597
    • Wier, P.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.