-
1
-
-
0032887329
-
An update on the therapeutic orphan
-
Wilson JT. An update on the therapeutic orphan. Pediatrics. 1999;104:585-590.
-
(1999)
Pediatrics
, vol.104
, pp. 585-590
-
-
Wilson, J.T.1
-
2
-
-
33748646758
-
Peer-reviewed publication of clinical trials completed for pediatric exclusivity
-
Benjamin DK Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006;296:1266-1273.
-
(2006)
JAMA
, vol.296
, pp. 1266-1273
-
-
Benjamin Jr, D.K.1
Smith, P.B.2
Murphy, M.D.3
-
3
-
-
33846865158
-
-
US General Accounting Office. Testimony before the Committee on Health, Education, Labor, and Pensions, US Senate. Pediatric drug research: substantial increase in studies of drugs for some children but challenges remains. GAO-01-705 T. http://www.gao.gov/new.items/d01705t.pdf. Accessibility verified January 5, 2007.
-
US General Accounting Office. Testimony before the Committee on Health, Education, Labor, and Pensions, US Senate. Pediatric drug research: substantial increase in studies of drugs for some children but challenges remains. GAO-01-705 T. http://www.gao.gov/new.items/d01705t.pdf. Accessibility verified January 5, 2007.
-
-
-
-
4
-
-
33846852047
-
-
Specific Requirements on Content and Format of Labeling for Human Prescription Drugs: Revision of Pediatric Use Subsection of Labeling. 59 Federal Register 64242 (1994).
-
Specific Requirements on Content and Format of Labeling for Human Prescription Drugs: Revision of "Pediatric Use" Subsection of Labeling. 59 Federal Register 64242 (1994).
-
-
-
-
5
-
-
33846856789
-
-
US Food and Drug Administration Modernization Act of 1997, Pub L No. 105-115, 111 Stat 2296 (1997).
-
US Food and Drug Administration Modernization Act of 1997, Pub L No. 105-115, 111 Stat 2296 (1997).
-
-
-
-
6
-
-
33846882881
-
-
Best Pharmaceuticals for Children Act of 2002, Pub L No. 107-109 (2002).
-
Best Pharmaceuticals for Children Act of 2002, Pub L No. 107-109 (2002).
-
-
-
-
7
-
-
33846888641
-
-
Public Citizen. Patently offensive: Congress set to extend monopoly patents for Cipro and other drugs. November 9, 2001. http://www.citizen.org/ congress/reform/drug_patents/pediatric/articles.cfm?ID=6435. Accessibility verified January 5, 2007.
-
Public Citizen. Patently offensive: Congress set to extend monopoly patents for Cipro and other drugs. November 9, 2001. http://www.citizen.org/ congress/reform/drug_patents/pediatric/articles.cfm?ID=6435. Accessibility verified January 5, 2007.
-
-
-
-
9
-
-
33846893719
-
-
US Food and Drug Administration. Summaries of medical and clinical pharmacology reviews of pediatric studies as of January 3, 2007. http://www.fda.gov/cder/pediatric/Summaryreview.htm. Accessibility verified January 5, 2007.
-
US Food and Drug Administration. Summaries of medical and clinical pharmacology reviews of pediatric studies as of January 3, 2007. http://www.fda.gov/cder/pediatric/Summaryreview.htm. Accessibility verified January 5, 2007.
-
-
-
-
10
-
-
85039231299
-
-
Fast Track Systems Clinical Trial Software home, January 5
-
Fast Track Systems Clinical Trial Software home page. http://www.fast-track.com. Accessibility verified January 5, 2007.
-
(2007)
Accessibility verified
-
-
-
12
-
-
0036441845
-
Returns on research and development for 1990s new drug introductions
-
Grabowski H, Vernon J, DiMasi JA. Returns on research and development for 1990s new drug introductions. Pharmacoeconomics. 2002;20(suppl 3):11-29.
-
(2002)
Pharmacoeconomics
, vol.20
, Issue.SUPPL. 3
, pp. 11-29
-
-
Grabowski, H.1
Vernon, J.2
DiMasi, J.A.3
-
13
-
-
33846875080
-
-
IMS Health home page. http://www.imshealth.com. Accessibility verified January 5, 2007.
-
IMS Health home page. http://www.imshealth.com. Accessibility verified January 5, 2007.
-
-
-
-
14
-
-
33846887240
-
Alternative contribution margin measures
-
Finkler SA, ed, Gaithersburg, Md: Aspen Publishers;
-
Finkler SA. Alternative contribution margin measures. In: Finkler SA, ed. Issues in Cost Accounting for Health Care Organizations. Gaithersburg, Md: Aspen Publishers; 1994:124-127.
-
(1994)
Issues in Cost Accounting for Health Care Organizations
, pp. 124-127
-
-
Finkler, S.A.1
-
15
-
-
4444349617
-
Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children?
-
Li JS, Berezny K, Kilaru R, et al. Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children? Hypertension. 2004;44:289-293.
-
(2004)
Hypertension
, vol.44
, pp. 289-293
-
-
Li, J.S.1
Berezny, K.2
Kilaru, R.3
-
16
-
-
4444363007
-
PATH-1 Investigators. A randomized, placebo-controlled trial of amlodipine in children with hypertension
-
Flynn JT, Newburger JW, Daniels SR, et al; PATH-1 Investigators. A randomized, placebo-controlled trial of amlodipine in children with hypertension. J Pediatr. 2004;145:353-359.
-
(2004)
J Pediatr
, vol.145
, pp. 353-359
-
-
Flynn, J.T.1
Newburger, J.W.2
Daniels, S.R.3
-
17
-
-
31944441962
-
Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections
-
Benjamin DK Jr, Driscoll T, Siebel NL, et al. Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother. 2006;50:632-638.
-
(2006)
Antimicrob Agents Chemother
, vol.50
, pp. 632-638
-
-
Benjamin Jr, D.K.1
Driscoll, T.2
Siebel, N.L.3
-
18
-
-
33646116056
-
the S. aureus Prevention Investigators. A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin
-
Benjamin DK Jr, Schelonka R, White R, et al; the S. aureus Prevention Investigators. A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. J Perinatol. 2006;26:290-295.
-
(2006)
J Perinatol
, vol.26
, pp. 290-295
-
-
Benjamin Jr, D.K.1
Schelonka, R.2
White, R.3
-
19
-
-
31344479078
-
Biomedical patents and the public's health: Is there a role for eminent domain?
-
Kesselheim AS, Avorn J. Biomedical patents and the public's health: is there a role for eminent domain? JAMA. 2006;295:434-436.
-
(2006)
JAMA
, vol.295
, pp. 434-436
-
-
Kesselheim, A.S.1
Avorn, J.2
-
20
-
-
27244448824
-
The patents-based pharmaceutical development process: Rationale, problems, and potential reforms
-
Barton JH, Emanuel EJ. The patents-based pharmaceutical development process: rationale, problems, and potential reforms. JAMA. 2005;294:2075-2082.
-
(2005)
JAMA
, vol.294
, pp. 2075-2082
-
-
Barton, J.H.1
Emanuel, E.J.2
-
22
-
-
5344234529
-
A black-box warning for antidepressants in children?
-
Newman TB. A black-box warning for antidepressants in children? N Engl J Med. 2004;351:1595-1598.
-
(2004)
N Engl J Med
, vol.351
, pp. 1595-1598
-
-
Newman, T.B.1
-
23
-
-
5344225688
-
Antidepressants and pediatric depression - the risk of doing nothing
-
Brent DA. Antidepressants and pediatric depression - the risk of doing nothing. N Engl J Med. 2004;351:1598-1601.
-
(2004)
N Engl J Med
, vol.351
, pp. 1598-1601
-
-
Brent, D.A.1
-
24
-
-
2342580158
-
Suicide caution stamped on antidepressants
-
Hampton T. Suicide caution stamped on antidepressants. JAMA. 2004;291:2060-2061.
-
(2004)
JAMA
, vol.291
, pp. 2060-2061
-
-
Hampton, T.1
-
25
-
-
33846878572
-
-
US Food and Drug Administration. Pediatric Exclusivity Labeling Changes as of November 22, 2006. http://www.fda.gov/cder/pediatric/labelchange.htm. Accessibility verified January 5, 2007.
-
US Food and Drug Administration. Pediatric Exclusivity Labeling Changes as of November 22, 2006. http://www.fda.gov/cder/pediatric/labelchange.htm. Accessibility verified January 5, 2007.
-
-
-
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