-
1
-
-
20644443605
-
-
Food and Drug Administration. Available at. (last accessed 1 September 2007).
-
Food and Drug Administration. Best Pharmaceuticals for Children Act. Available at http://www.fda.gov/opacom/laws/pharmkids/contents.html (last accessed 1 September 2007).
-
Best Pharmaceuticals for Children Act
-
-
-
2
-
-
33748529495
-
-
Food and Drug Administration. Available at. (last accessed 1 September 2007).
-
Food and Drug Administration. Pediatric Research Equity Act. Available at http://www.fda.gov/cder/pediatric/S-650-PREA.pdf (last accessed 1 September 2007).
-
Pediatric Research Equity Act
-
-
-
4
-
-
84871225314
-
-
European Medicines Agency. Available at. (last accessed 15 April 2008).
-
European Medicines Agency. The EU Paediatric Regulation, 2007. Available at http://www.emea.europa.eu/htms/human/paediatrics/regulation.htm (last accessed 15 April 2008).
-
The EU Paediatric Regulation, 2007
-
-
-
5
-
-
33747073512
-
Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002
-
Balakrishnan K, Grieve J, Tordoff J, Norris P, Reith D. Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002. J Clin Pharmacol 2006 46 : 1038 43.
-
(2006)
J Clin Pharmacol
, vol.46
, pp. 1038-43
-
-
Balakrishnan, K.1
Grieve, J.2
Tordoff, J.3
Norris, P.4
Reith, D.5
-
6
-
-
33748646758
-
Peer-reviewed publication of clinical trials completed for pediatric exclusivity
-
Benjamin DKJ, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf RM, Li JS. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 2006 296 : 1266 73.
-
(2006)
JAMA
, vol.296
, pp. 1266-73
-
-
Benjamin, D.K.J.1
Smith, P.B.2
Murphy, M.D.3
Roberts, R.4
Mathis, L.5
Avant, D.6
Califf, R.M.7
Li, J.S.8
-
7
-
-
20644445855
-
Effect of the Pediatric Exclusivity Provision on children's access to medicines
-
Grieve J, Tordoff J, Reith D, Norris P. Effect of the Pediatric Exclusivity Provision on children's access to medicines. Br J Clin Pharmacol 2005 59 : 730 5.
-
(2005)
Br J Clin Pharmacol
, vol.59
, pp. 730-5
-
-
Grieve, J.1
Tordoff, J.2
Reith, D.3
Norris, P.4
-
8
-
-
33846878293
-
Economic return of clinical trials performed under the pediatric exclusivity program
-
Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, Goldsmith JV, Murphy MD, Califf RM, Benjamin DKJ. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 2007 297 : 480 8.
-
(2007)
JAMA
, vol.297
, pp. 480-8
-
-
Li, J.S.1
Eisenstein, E.L.2
Grabowski, H.G.3
Reid, E.D.4
Mangum, B.5
Schulman, K.A.6
Goldsmith, J.V.7
Murphy, M.D.8
Califf, R.M.9
Benjamin, D.K.J.10
-
9
-
-
33845425396
-
Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998 to 2002
-
Balakrishnan K, Tordoff J, Norris P, Reith D. Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998 to 2002. Br J Clin Pharmacol 2007 63 : 85 91.
-
(2007)
Br J Clin Pharmacol
, vol.63
, pp. 85-91
-
-
Balakrishnan, K.1
Tordoff, J.2
Norris, P.3
Reith, D.4
-
10
-
-
1542329750
-
Trends in accessibility to medicines for children in New Zealand: 1998-2002
-
Chui J, Tordoff J, Kennedy J, Reith D. Trends in accessibility to medicines for children in New Zealand: 1998-2002. Br J Clin Pharmacol 2004 57 : 322 7.
-
(2004)
Br J Clin Pharmacol
, vol.57
, pp. 322-7
-
-
Chui, J.1
Tordoff, J.2
Kennedy, J.3
Reith, D.4
-
11
-
-
20644454390
-
Changes in availability of paediatric medicines in Australia between 1998 and 2002
-
Chui J, Tordoff J, Reith D. Changes in availability of paediatric medicines in Australia between 1998 and 2002. Br J Clin Pharmacol 2005 59 : 736 42.
-
(2005)
Br J Clin Pharmacol
, vol.59
, pp. 736-42
-
-
Chui, J.1
Tordoff, J.2
Reith, D.3
-
12
-
-
0033019892
-
Pediatric drug formulations: Challenges and potential solutions
-
Nahata MC. Pediatric drug formulations: challenges and potential solutions. Ann Pharmacother 1999 33 : 247 9.
-
(1999)
Ann Pharmacother
, vol.33
, pp. 247-9
-
-
Nahata, M.C.1
-
13
-
-
62949121605
-
-
American Academy of Pediatrics. Available at. (last accessed 15 April 2008).
-
American Academy of Pediatrics. Side-by-side comparison of 2007 reauthorization and prior law. Available at http://www.aap.org/advocacy/washing/ Therapeutics/docs/bpcareasidexside.pdf (last accessed 15 April 2008).
-
Side-by-side Comparison of 2007 Reauthorization and Prior Law
-
-
-
19
-
-
62949170775
-
-
WHO Collaborating Centre for Drug Statistics Methodology. Available at. (last accessed 15 April 2008).
-
WHO Collaborating Centre for Drug Statistics Methodology. ATC Index 2008. Available at http://www.whocc.no/atcddd (last accessed 15 April 2008).
-
ATC Index 2008
-
-
-
21
-
-
33750381075
-
-
Food and Drug Administration. Available at. (last accessed 30 September 2007).
-
Food and Drug Administration. Vioxx (rofecoxib) Questions and Answers. Available at http://www.fda.gov/Cder/drug/infopage/vioxx/vioxxQA.htm (last accessed 30 September 2007).
-
Vioxx (Rofecoxib) Questions and Answers
-
-
-
22
-
-
19744380776
-
Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial
-
Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA, Polyp A. Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005 352 : 1092 102.
-
(2005)
N Engl J Med
, vol.352
, pp. 1092-102
-
-
Bresalier, R.S.1
Sandler, R.S.2
Quan, H.3
Bolognese, J.A.4
Oxenius, B.5
Horgan, K.6
Lines, C.7
Riddell, R.8
Morton, D.9
Lanas, A.10
Konstam, M.A.11
Baron, J.A.12
Polyp, A.13
-
24
-
-
72149126826
-
-
US Food and Drug Administration Center for Drug Evaluation and Reasearch., 30 September 2007.
-
US Food and Drug Administration Center for Drug Evaluation and Reasearch. Pediatric Exclusivity Labeling, 30 September 2007.
-
Pediatric Exclusivity Labeling
-
-
|