메뉴 건너뛰기




Volumn 691, Issue , 2011, Pages 17-35

Preclinical Evaluation of Juvenile Toxicity

Author keywords

Juvenile animals; Pediatric; Safety testing; Toxicology

Indexed keywords

ADULT; AGING; ANIMAL; ANIMAL MODEL; ARTICLE; BIOASSAY; BODY WEIGHT; CARDIOVASCULAR SYSTEM; CHEMICALLY INDUCED DISORDER; CHILD; DRUG APPROVAL; DRUG EFFECT; DRUG SCREENING; DRUG TOXICITY; EUROPE; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; MALE; METHODOLOGY; NEUROLOGIC DISEASE; PHYSIOLOGY; SPECIES DIFFERENCE; TOXICITY TESTING; UNITED STATES;

EID: 79952201221     PISSN: 10643745     EISSN: 19406029     Source Type: Book Series    
DOI: 10.1007/978-1-60761-849-2_2     Document Type: Chapter
Times cited : (32)

References (38)
  • 1
    • 0034605790 scopus 로고    scopus 로고
    • Clinical trials of medicines in children: US experience shows how to ensure that treatment of children is evidence based
    • Choonara, I. (2000) Clinical trials of medicines in children: US experience shows how to ensure that treatment of children is evidence based. Br. Med. J. 321, 1093–1094.
    • (2000) Br. Med. J , vol.321 , pp. 1093-1094
    • Choonara, I.1
  • 2
    • 0032995179 scopus 로고    scopus 로고
    • Unlicensed and off label drug use in neonates
    • Conroy, S., McIntyre, J., and Choonara, I. (1999) Unlicensed and off label drug use in neonates. Arch. Dis. Child. 80, F142–F145.
    • (1999) Arch. Dis. Child , vol.80 , pp. F142-F145
    • Conroy, S.1    McIntyre, J.2    Choonara, I.3
  • 4
    • 0028950350 scopus 로고
    • Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
    • Committee on Drugs, American Academy of Pediatrics. (1995) Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations. Pediatrics 95(2), 286–294.
    • (1995) Pediatrics , vol.95 , Issue.2 , pp. 286-294
  • 7
    • 0000358397 scopus 로고    scopus 로고
    • Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients
    • FDA (1998a) Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Fed. Regist. 63, 66632–66672.
    • (1998) Fed. Regist , vol.63 , pp. 66632-66672
  • 8
    • 85194800337 scopus 로고    scopus 로고
    • List of drugs for which additional pediatric information may produce health benefits in the pediatric population
    • FDA (1998b) List of drugs for which additional pediatric information may produce health benefits in the pediatric population. Fed. Regist. 63, 27732–27733.
    • (1998) Fed. Regist , vol.63 , pp. 27732-27733
  • 10
    • 85194811209 scopus 로고    scopus 로고
    • Consulted 19 May 2008
    • FDA (2007) Should your child be in a clinical trial? http://www.fda.gov/consumer/updates/pediatrictrial101507.html. Consulted 19 May 2008.
    • (2007) Should your child be in a clinical trial?
  • 11
    • 0005710462 scopus 로고    scopus 로고
    • E11: Clinical investigation of medicinal products in the pediatric population
    • ICH (2000b) E11: Clinical investigation of medicinal products in the pediatric population. Fed. Regist. 65, 19777–19781.
    • (2000) Fed. Regist , vol.65 , pp. 19777-19781
  • 15
    • 0013100563 scopus 로고
    • Step 4 tripartite harmonised guidelines. Detection of toxicity to reproduction for medicinal products
    • (D’Arcy, P.F., and Harron, D.W.G., eds), Queen’s University: Belfast
    • ICH (1994) Step 4 tripartite harmonised guidelines. Detection of toxicity to reproduction for medicinal products, in Proceedings of the second international conference on harmon-isation Orlando (D’Arcy, P.F., and Harron, D.W.G., eds.), Queen’s University: Belfast. pp. 557–578.
    • (1994) Proceedings of the second international conference on harmon-isation Orlando , pp. 557-578
  • 16
    • 0013638108 scopus 로고
    • Technical procedures in reproduction toxicology
    • Royal Society of Medicine, London
    • Barrow, P. (1990) Technical procedures in reproduction toxicology. Laboratory animals handbooks 11. Royal Society of Medicine, London.
    • (1990) Laboratory animals handbooks 11
    • Barrow, P.1
  • 17
    • 2342523349 scopus 로고    scopus 로고
    • Developing drugs for pediatric use: A role for juvenile animal studies?
    • Baldrick, P. (2004) Developing drugs for pediatric use: A role for juvenile animal studies? Regul. Toxicol. Pharmacol. 39, 381–389.
    • (2004) Regul. Toxicol. Pharmacol , vol.39 , pp. 381-389
    • Baldrick, P.1
  • 18
    • 4444253244 scopus 로고    scopus 로고
    • Workshop Summary. Juvenile animal studies: Testing strategies and design
    • Hurtt, M.E. (2004) Workshop Summary. Juvenile animal studies: Testing strategies and design. Birth Defects Res. B Dev. Reprod. Toxicol. 71(4), 281–288.
    • (2004) Birth Defects Res. B Dev. Reprod. Toxicol , vol.71 , Issue.4 , pp. 281-288
    • Hurtt, M.E.1
  • 22
    • 0000181727 scopus 로고    scopus 로고
    • Reproductive and developmental toxicology safety studies
    • (Krinke, G.J., ed), Academic Press, London
    • Barrow, P. (2000) Reproductive and developmental toxicology safety studies, in The laboratory rat. (Krinke, G.J., ed.), Academic Press, London, pp. 199–225.
    • (2000) The laboratory rat , pp. 199-225
    • Barrow, P.1
  • 23
    • 85194805886 scopus 로고    scopus 로고
    • consulted 16 May 2008
    • NCR3S (2008) Blood sampling microsite. http://www.nc3rs.org.uk/bloodsampling-microsite/page.asp?id=346, consulted 16 May 2008.
    • (2008) Blood sampling microsite
  • 24
    • 24644502694 scopus 로고    scopus 로고
    • Immune assessments in developmental and juvenile toxicology: Practical considerations for the regulatory safety testing of pharmaceuticals
    • Barrow, P.C., and Ravel, G. (2005) Immune assessments in developmental and juvenile toxicology: Practical considerations for the regulatory safety testing of pharmaceuticals. Regul. Toxicol. Pharmacol. 43, 35–44.
    • (2005) Regul. Toxicol. Pharmacol , vol.43 , pp. 35-44
    • Barrow, P.C.1    Ravel, G.2
  • 26
    • 0141885479 scopus 로고    scopus 로고
    • Landmarks in the development of the female reproductive system
    • Beckman, D.A., and Feuston, M. (2003) Landmarks in the development of the female reproductive system. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 137–143.
    • (2003) Birth Defects Res. B Dev. Reprod. Toxicol , vol.68 , pp. 137-143
    • Beckman, D.A.1    Feuston, M.2
  • 27
    • 0141959158 scopus 로고    scopus 로고
    • Postnatal anatomical and functional development of the heart: A species comparison
    • Hew, K.W., and Keller, K.A. (2003) Postnatal anatomical and functional development of the heart: A species comparison. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 309–320.
    • (2003) Birth Defects Res. B Dev. Reprod. Toxicol , vol.68 , pp. 309-320
    • Hew, K.W.1    Keller, K.A.2
  • 34
    • 0141919897 scopus 로고    scopus 로고
    • Species comparison of anatomical and functional renal development
    • Zoetis, T., and Hurtt, M.E. (2003) Species comparison of anatomical and functional renal development. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 111–120.
    • (2003) Birth Defects Res. B Dev. Reprod. Toxicol , vol.68 , pp. 111-120
    • Zoetis, T.1    Hurtt, M.E.2
  • 37
    • 0002813320 scopus 로고    scopus 로고
    • Behavioral assessment in developmental neurotoxicology
    • (Slikker, W., and Chang, L.W., eds), Academic Press, San Diego
    • Meyer, J.S. (1998) Behavioral assessment in developmental neurotoxicology, in Handbook of developmental neurotoxicology (Slikker, W., and Chang, L.W., eds.), Academic Press, San Diego, pp. 403–426.
    • (1998) Handbook of developmental neurotoxicology , pp. 403-426
    • Meyer, J.S.1
  • 38
    • 67650774974 scopus 로고    scopus 로고
    • Toxicology testing for products intended for pediatric populations
    • (Sietsema, W.K., and Schwen, R., eds) FDA News, Washington, D.C
    • Barrow, P. (2007) Toxicology testing for products intended for pediatric populations, in Nonclinical drug safety assessment: Practical considerations for successful registration, (Sietsema, W.K., and Schwen, R., eds.) FDA News, Washington, D.C., pp. 411–440.
    • (2007) Nonclinical drug safety assessment: Practical considerations for successful registration , pp. 411-440
    • Barrow, P.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.