-
1
-
-
0034605790
-
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
-
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
-
3
-
-
20244368931
-
Survey of unlicensed and off label drug use in pediatric wards in European countries
-
Conroy, S., Choonara, I., Impicciatore, P., Mohn, A., Arnell, H., Rane, A., Knoeppel, C., Seyberth, H., Pandolfini, C., Raffaelli, M.P., Rocchi, F., Bonati, M., ‘t Jong, G., de Hoog, M., and van den Anker, J. (2000) Survey of unlicensed and off label drug use in pediatric wards in European countries. Br. Med. J. 320, 79–82.
-
(2000)
Br. Med. J
, vol.320
, pp. 79-82
-
-
Conroy, S.1
Choonara, I.2
Impicciatore, P.3
Mohn, A.4
Arnell, H.5
Rane, A.6
Knoeppel, C.7
Seyberth, H.8
Pandolfini, C.9
Raffaelli, M.P.10
Rocchi, F.11
Bonati, M.12
t Jong, G.13
de Hoog, M.14
van den Anker, J.15
-
4
-
-
0028950350
-
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
-
-
-
6
-
-
0003970081
-
-
ILSI Press, Washington, D.C
-
Guzelian, P.S., Henry, C.J., and Olin, S.S. (1992) Similarities and differences between children and adults: Implications for risk assessment. ILSI Press, Washington, D.C.
-
(1992)
Similarities and differences between children and adults: Implications for risk assessment
-
-
Guzelian, P.S.1
Henry, C.J.2
Olin, S.S.3
-
7
-
-
0000358397
-
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
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
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
-
27
-
-
0141959158
-
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
-
28
-
-
0141959124
-
Species comparison of anatomical and functional immune system development
-
Holsapple, M.P., West, L.J., and Landreth, K.S. (2003) Species comparison of anatomical and functional immune system development. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 321–334.
-
(2003)
Birth Defects Res. B Dev. Reprod. Toxicol
, vol.68
, pp. 321-334
-
-
Holsapple, M.P.1
West, L.J.2
Landreth, K.S.3
-
29
-
-
0141885477
-
Development and maturation of the male reproductive system
-
Marty, M.S., Chapin, R.E., Parks, L.G., and Thorsrud, B.A. (2003) Development and maturation of the male reproductive system. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 125–136.
-
(2003)
Birth Defects Res. B Dev. Reprod. Toxicol
, vol.68
, pp. 125-136
-
-
Marty, M.S.1
Chapin, R.E.2
Parks, L.G.3
Thorsrud, B.A.4
-
30
-
-
18244395539
-
Postnatal development of the gastrointestinal system: A species comparison
-
Walthall, K., Cappon, G.D., Hurtt, M.E., and Zoetis, T. (2005) Postnatal development of the gastrointestinal system: A species comparison. Birth Defects Res. B Dev. Reprod. Toxicol. 74, 132–156.
-
(2005)
Birth Defects Res. B Dev. Reprod. Toxicol
, vol.74
, pp. 132-156
-
-
Walthall, K.1
Cappon, G.D.2
Hurtt, M.E.3
Zoetis, T.4
-
31
-
-
33750489426
-
Postnatal growth and morphological development of the brain: A species comparison
-
Watson, R.E., DeSesso, J.M., Hurtt, M.E., and Cappon, G.D. (2006) Postnatal growth and morphological development of the brain: A species comparison. Birth Defects Res. B Dev. Reprod. Toxicol. 77, 471–484.
-
(2006)
Birth Defects Res. B Dev. Reprod. Toxicol
, vol.77
, pp. 471-484
-
-
Watson, R.E.1
DeSesso, J.M.2
Hurtt, M.E.3
Cappon, G.D.4
-
32
-
-
1242314668
-
Species comparison of postnatal CNS development: Functional measures
-
Wood, S.L., Beyer, B.K., and Cappon, G.D. (2003) Species comparison of postnatal CNS development: Functional measures. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 391–407.
-
(2003)
Birth Defects Res. B Dev. Reprod. Toxicol
, vol.68
, pp. 391-407
-
-
Wood, S.L.1
Beyer, B.K.2
Cappon, G.D.3
-
33
-
-
0141954350
-
Species comparison of postnatal bone growth and development
-
Zoetis, T., Tassinari, M.S., Bagi, C., Walthall, K., and Hurtt, M.E. (2003) Species comparison of postnatal bone growth and development. Birth Defects Res. B Dev. Reprod. Toxicol. 68, 86–110.
-
(2003)
Birth Defects Res. B Dev. Reprod. Toxicol
, vol.68
, pp. 86-110
-
-
Zoetis, T.1
Tassinari, M.S.2
Bagi, C.3
Walthall, K.4
Hurtt, M.E.5
-
34
-
-
0141919897
-
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
-
36
-
-
85123815623
-
Nonclinical juvenile toxicity testing
-
2nd ed. (Hood, R. D., ed), CRC Press, Boca Raton
-
Beck, M.J., Padgett, E.L., Bowman, C.J., Wilson, D.T., Kaufman, L.E., Varsho, B.J., Stump, D.G., Nemec, M.D., and Holson, J.F. (2006) Nonclinical juvenile toxicity testing, in Developmental and reproductive toxicology: A practical approach, 2nd ed. (Hood, R. D., ed.), CRC Press, Boca Raton, pp. 263–328.
-
(2006)
Developmental and reproductive toxicology: A practical approach
, pp. 263-328
-
-
Beck, M.J.1
Padgett, E.L.2
Bowman, C.J.3
Wilson, D.T.4
Kaufman, L.E.5
Varsho, B.J.6
Stump, D.G.7
Nemec, M.D.8
Holson, J.F.9
-
37
-
-
0002813320
-
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
-
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
|