-
1
-
-
84872239004
-
-
Frontline Nov 4
-
Frontline. 2002. Interview: Sidney Wolfe, M.D. WGBH-TV, Nov. 4. http://www.pbs.org/wgbh/pages/frontline/shows/prescription/interviews/wolfe.html
-
(2002)
Interview: Sidney Wolfe, M.D. WGBH-TV
-
-
-
2
-
-
84872235422
-
The FDA stands by dangerous drugs, do you?
-
Oct 11
-
Roberts C. 2006. The FDA stands by dangerous drugs, do you? Doc Roberts, Oct. 11. http://www. docroberts.com/ar-20-c-16-the-fda-stands-by-dangerous- drugs-do-you.aspx
-
(2006)
Doc Roberts
-
-
Roberts, C.1
-
3
-
-
84884238458
-
How the FDA may kill millions of us
-
Forbes S Feb 14
-
Forbes S. 2011. How the FDA may kill millions of us. Forbes, Feb. 14. http://www.forbes.com/forbes/2011/0214/opinions-steve-forbes-fact-comment-fda- may-kill-millions.html
-
(2011)
Forbes
-
-
-
4
-
-
84872234968
-
-
Support of Science at the FDA, Before the Subcomm statement of AC von Eschenbach, Acting Commissioner of the US Food and Drug Administration
-
Support of Science at the FDA, Before the Subcomm. on Oversight and Investigations, House Comm. on Energy and Commerce, US House of Representatives. 2008. (statement of AC von Eschenbach, Acting Commissioner of the US Food and Drug Administration) http://www.hhs.gov/asl/testify/2008/01/t20080129c.html
-
(2008)
On Oversight and Investigations, House Comm. on Energy and Commerce, US House of Representatives
-
-
-
5
-
-
79952055751
-
Advancing regulatory science
-
Hamburg MA. 2011. Advancing regulatory science. Science 331:987
-
(2011)
Science
, vol.331
, pp. 987
-
-
Hamburg, M.A.1
-
6
-
-
84872232396
-
History of food and drug regulation in the United States
-
Feb 4
-
Law MT. 2004. History of food and drug regulation in the United States. EH.net, Econ. Hist. Assoc., Feb. 4. http://eh.net/encyclopedia/article/Law.Food. and.Drug.Regulation
-
(2004)
EH.net, Econ. Hist. Assoc
-
-
Law, M.T.1
-
7
-
-
84872245194
-
-
US Food Drug Admin US Food Drug Admin., May 13
-
US Food Drug Admin. 2009. Centennial of FDA. US Food Drug Admin., May 13. http://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/default.htm
-
(2009)
Centennial of FDA
-
-
-
8
-
-
0024321898
-
Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
-
The Cardiac Arrhythmia Suppression Trial (CAST) Investigators
-
The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. 1989. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N. Engl. J. Med. 321:406-12
-
(1989)
N. Engl. J. Med
, vol.321
, pp. 406-412
-
-
-
9
-
-
0025222965
-
Torsades de pointes occurring in association with terfenadine use
-
Monahan BP, Ferguson CL, Killeavy ES, Lloyd BK, Troy J, Cantilena LR Jr. 1990. Torsades de pointes occurring in association with terfenadine use. JAMA 264:2788-90
-
(1990)
JAMA
, vol.264
, pp. 2788-2790
-
-
Monahan, B.P.1
Ferguson, C.L.2
Killeavy, E.S.3
Lloyd, B.K.4
Troy, J.5
Cantilena Jr., L.R.6
-
10
-
-
0031915680
-
Asymptomatic mitral and aortic valve disease is seen in half of the patients taking 'phen-fen.'
-
Griffen L, Anchors M. 1998. Asymptomatic mitral and aortic valve disease is seen in half of the patients taking 'phen-fen.' Arch. Intern. Med. 158:102
-
(1998)
Arch. Intern. Med
, vol.158
, pp. 102
-
-
Griffen, L.1
Anchors, M.2
-
11
-
-
0023175454
-
Genotoxicity, toxicity, and carcinogenicity of the antihistamine methapyrilene
-
Mirsalis JC. 1987. Genotoxicity, toxicity, and carcinogenicity of the antihistamine methapyrilene. Mutat. Res. 185:309-17
-
(1987)
Mutat. Res
, vol.185
, pp. 309-317
-
-
Mirsalis, J.C.1
-
12
-
-
84872243783
-
Systems pharmacology to predict drug toxicity: Integration across levels of biological organization
-
Bai JPF, Abernethy DR. 2013. Systems pharmacology to predict drug toxicity: integration across levels of biological organization. Annu. Rev. Pharmacol. Toxicol. 53:451-73
-
(2013)
Annu. Rev. Pharmacol. Toxicol
, vol.53
, pp. 451-473
-
-
Jpf, B.1
Abernethy, D.R.2
-
13
-
-
0038931405
-
Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system
-
DuMouchel W. 1999. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am. Stat. 53:177-90
-
(1999)
Am. Stat
, vol.53
, pp. 177-190
-
-
Dumouchel, W.1
-
14
-
-
0036300732
-
Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
-
Szarfman A, Machado SG, O'Neill RT. 2002. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf. 25:381-92
-
(2002)
Drug Saf
, vol.25
, pp. 381-392
-
-
Szarfman, A.1
MacHado, S.G.2
O'Neill, R.T.3
-
15
-
-
67649425383
-
Postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999-2002
-
Bottone FG Jr, Barry WT. 2009. Postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999-2002. Curr. Med. Res. Opin. 25:1535-50
-
(2009)
Curr. Med. Res. Opin
, vol.25
, pp. 1535-1550
-
-
Bottone Jr., F.G.1
Barry, W.T.2
-
16
-
-
84858782552
-
Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: A disproportionality analysis of the US FDA adverse event reporting system database
-
Motola D, Piccinni C, Biagi C, Raschi E, Marra A, et al. 2012. Cardiovascular, ocular and bone adverse reactions associated with thiazolidinediones: a disproportionality analysis of the US FDA adverse event reporting system database. Drug Saf. 35:315-23
-
(2012)
Drug Saf
, vol.35
, pp. 315-323
-
-
Motola, D.1
Piccinni, C.2
Biagi, C.3
Raschi, E.4
Marra, A.5
-
17
-
-
83755196415
-
Statin-associated muscular and renal adverse events: Datamining of the public version of the FDA adverse event reporting system
-
SakaedaT,KadoyamaK,Okuno Y. 2011. Statin-associated muscular and renal adverse events: datamining of the public version of the FDA adverse event reporting system. PLoS ONE 6:e28124
-
(2011)
PLoS ONE
, vol.6
-
-
Sakaeda, T.1
Kadoyama, K.2
Okuno, Y.3
-
18
-
-
78149349684
-
-
US Food Drug Admin US Food Drug Admin., Aug 6
-
US Food Drug Admin. 2012. FDA's Sentinel Initiative. US Food Drug Admin., Aug. 6. http://www. fda.gov/Safety/FDAsSentinelInitiative/default.htm
-
(2012)
FDA's Sentinel Initiative
-
-
-
19
-
-
84856034278
-
The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety
-
Robb MA, Racoosin JA, Sherman RE, Gross TP, Ball R, et al. 2012. The US Food and Drug Administration's Sentinel Initiative: expanding the horizons of medical product safety. Pharmacoepidemiol. Drug Saf. 21(Suppl. 1):9-11
-
(2012)
Pharmacoepidemiol. Drug Saf
, vol.21
, Issue.SUPPL. 1
, pp. 9-11
-
-
Robb, M.A.1
Racoosin, J.A.2
Sherman, R.E.3
Gross, T.P.4
Ball, R.5
-
20
-
-
79851472033
-
Developing the Sentinel System-a national resource for evidence development
-
Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, Platt R. 2011. Developing the Sentinel System-a national resource for evidence development. N. Engl. J. Med. 364:498-99
-
(2011)
N. Engl. J. Med
, vol.364
, pp. 498-499
-
-
Behrman, R.E.1
Benner, J.S.2
Brown, J.S.3
McClellan, M.4
Woodcock, J.5
Platt, R.6
-
21
-
-
84862932391
-
The U.S. Food and Drug Administration's Mini-Sentinel program: Status and direction
-
Platt R, Carnahan RM, Brown JS, Chrischilles E, Curtis LH, et al. 2012. The U.S. Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol. Drug Saf. 21(Suppl. 1):1-8
-
(2012)
Pharmacoepidemiol. Drug Saf
, vol.21
, Issue.SUPPL. 1
, pp. 1-8
-
-
Platt, R.1
Carnahan, R.M.2
Brown, J.S.3
Chrischilles, E.4
Curtis, L.H.5
-
23
-
-
0025365450
-
CAST: Implications for drug development
-
Woosley RL. 1990. CAST: implications for drug development. Clin. Pharmacol. Ther. 47(5):553-56
-
(1990)
Clin. Pharmacol. Ther
, vol.47
, Issue.5
, pp. 553-556
-
-
Woosley, R.L.1
-
24
-
-
0025778744
-
The healthy responder phenomenon in non-randomized clinical trials
-
Hallstrom AP, Greene HL, Huther ML. 1991. The healthy responder phenomenon in non-randomized clinical trials. Stat. Med. 10:1621-31
-
(1991)
Stat. Med
, vol.10
, pp. 1621-1631
-
-
Hallstrom, A.P.1
Greene, H.L.2
Huther, M.L.3
-
26
-
-
34250212715
-
Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
-
Nissen SE, Wolski K. 2007. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N. Engl. J. Med. 356:2457-71
-
(2007)
N. Engl. J. Med
, vol.356
, pp. 2457-2471
-
-
Nissen, S.E.1
Wolski, K.2
-
27
-
-
0035934070
-
Risk of cardiovascular events associated with selective COX-2 inhibitors
-
Mukherjee D, Nissen SE, Topol EJ. 2001. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 286:954-59
-
(2001)
JAMA
, vol.286
, pp. 954-959
-
-
Mukherjee, D.1
Nissen, S.E.2
Topol, E.J.3
-
28
-
-
84872242231
-
Centers for Education and Research on Therapeutics (CERTs) overview: Fact sheet
-
Agency Healthc. Res. Qual Agency Healthc. Res. Qual., Rockville, MD
-
Agency Healthc. Res. Qual. 2008. Centers for Education and Research on Therapeutics (CERTs) overview: fact sheet. AHRQ publ. 08-P009-EF, Agency Healthc. Res. Qual., Rockville, MD. http://www.certs.hhs.gov/about/certsovr.htm
-
(2008)
AHRQ Publ. 08-P009-EF
-
-
-
29
-
-
84872250267
-
Centers for education and research in therapeutics
-
Woosley RL. 1998. Centers for education and research in therapeutics. Pharmacologist 40:69
-
(1998)
Pharmacologist
, vol.40
, pp. 69
-
-
Woosley, R.L.1
-
30
-
-
0017859475
-
The US drug efficacy study and its implication (DESI)
-
WardellWM. 1978. The US Drug Efficacy Study and its implication (DESI). Agents Actions 8:421-22
-
(1978)
Agents Actions
, vol.8
, pp. 421-422
-
-
Wardell, W.M.1
-
31
-
-
0042833216
-
Randomized concentration-controlled trials: Motivations, use, and limitations
-
Kraiczi H, Jang T, Ludden T, Peck CC. 2003. Randomized concentration-controlled trials: motivations, use, and limitations. Clin. Pharmacol. Ther. 74:203-14
-
(2003)
Clin. Pharmacol. Ther
, vol.74
, pp. 203-214
-
-
Kraiczi, H.1
Jang, T.2
Ludden, T.3
Peck, C.C.4
-
32
-
-
34248680469
-
Physiologically based pharmacokinetics in drug development and regulatory science: A workshop report (Georgetown University, Washington, DC, May 29-30, 2002
-
Rowland M, Balant L, Peck C. 2004. Physiologically based pharmacokinetics in drug development and regulatory science: a workshop report (Georgetown University, Washington, DC, May 29-30, 2002). AAPS J. 6:56-67
-
(2004)
AAPS J
, vol.6
, pp. 56-67
-
-
Rowland, M.1
Balant, L.2
Peck, C.3
-
33
-
-
30444450822
-
Evidence of effectiveness: How much can we extrapolate from existing studies?
-
Lee H, Yim DS, Zhou H, Peck CC. 2005. Evidence of effectiveness: How much can we extrapolate from existing studies? AAPS J. 7:E467-74
-
(2005)
AAPS J
, vol.7
-
-
Lee, H.1
Yim, D.S.2
Zhou, H.3
Peck, C.C.4
-
34
-
-
0029589769
-
A new method to explore the distribution of interindividual random effects in non-linear mixed effects models
-
Fattinger KE, Sheiner LB, Verotta D. 1995. A new method to explore the distribution of interindividual random effects in non-linear mixed effects models. Biometrics 51:1236-51
-
(1995)
Biometrics
, vol.51
, pp. 1236-1251
-
-
Fattinger, K.E.1
Sheiner, L.B.2
Verotta, D.3
-
35
-
-
28444462494
-
Population pharmacokinetics of the active metabolite of leflunomide in pediatric subjects with polyarticular course juvenile rheumatoid arthritis
-
Shi J, Kovacs SJ, Wang Y, Ludden TM, Bhargava VO. 2005. Population pharmacokinetics of the active metabolite of leflunomide in pediatric subjects with polyarticular course juvenile rheumatoid arthritis. J. Pharmacokinet. Pharmacodyn. 32:419-39
-
(2005)
J. Pharmacokinet. Pharmacodyn
, vol.32
, pp. 419-439
-
-
Shi, J.1
Kovacs, S.J.2
Wang, Y.3
Ludden, T.M.4
Bhargava, V.O.5
-
36
-
-
79951765993
-
Physiologically-based pharmacokinetics in drug development and regulatory science
-
Rowland M, Peck C, Tucker G. 2011. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu. Rev. Pharmacol. Toxicol. 51:45-73
-
(2011)
Annu. Rev. Pharmacol. Toxicol
, vol.51
, pp. 45-73
-
-
Rowland, M.1
Peck, C.2
Tucker, G.3
-
37
-
-
4344645978
-
Can the pharmaceutical industry reduce attrition rates?
-
Kola I, Landis J. 2004. Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3:711-15
-
(2004)
Nat. Rev. Drug Discov
, vol.3
, pp. 711-715
-
-
Kola, I.1
Landis, J.2
-
38
-
-
0003556719
-
-
US Dep. Health Hum. Serv., US Food Drug Admin., Cent. Drug Eval. Res., Cent. Biol. Eval. Res Feb. 1999, US Food Drug Admin., Rockville, MD
-
US Dep. Health Hum. Serv., US Food Drug Admin., Cent. Drug Eval. Res., Cent. Biol. Eval. Res. 1999. Guidance for industry: population pharmacokinetics. Feb. 1999, US Food Drug Admin., Rockville, MD. http://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/WomensHealthResearch/UCM133184.pdf
-
(1999)
Guidance for Industry: Population Pharmacokinetics
-
-
-
39
-
-
0035037328
-
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
-
Lesko LJ, Atkinson AJ Jr. 2001. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu. Rev. Pharmacol. Toxicol. 41:347-66
-
(2001)
Annu. Rev. Pharmacol. Toxicol
, vol.41
, pp. 347-366
-
-
Lesko, L.J.1
Atkinson Jr., A.J.2
-
40
-
-
0347136017
-
Pharmacogenomics in drug development and regulatory decision-making: The Genomic Data Submission (GDS) proposal
-
Salerno RA, Lesko LJ. 2004. Pharmacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal. Pharmacogenomics 5:25-30
-
(2004)
Pharmacogenomics
, vol.5
, pp. 25-30
-
-
Salerno, R.A.1
Lesko, L.J.2
-
41
-
-
33645010143
-
Application of pharmacogenomics in clinical pharmacology
-
Huang SM, Goodsaid F, Rahman A, Frueh F, Lesko LJ. 2006. Application of pharmacogenomics in clinical pharmacology. Toxicol. Mech. Methods 16:89-99
-
(2006)
Toxicol. Mech. Methods
, vol.16
, pp. 89-99
-
-
Huang, S.M.1
Goodsaid, F.2
Rahman, A.3
Frueh, F.4
Lesko, L.J.5
-
42
-
-
49949098665
-
The critical path of warfarin dosing: Finding an optimal dosing strategy using pharmacogenetics
-
Lesko LJ. 2008. The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics. Clin. Pharmacol. Ther. 84:301-3
-
(2008)
Clin. Pharmacol. Ther
, vol.84
, pp. 301-303
-
-
Lesko, L.J.1
-
43
-
-
48249093095
-
Integration and use of biomarkers in drug development, regulation and clinical practice: A US regulatory perspective
-
Amur S, Frueh FW, Lesko LJ,Huang SM. 2008. Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective. Biomark. Med. 2:305-11
-
(2008)
Biomark. Med
, vol.2
, pp. 305-311
-
-
Amur, S.1
Frueh, F.W.2
Lesko Ljhuang, S.M.3
-
45
-
-
0033673839
-
Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans
-
Lesko LJ, Rowland M, Peck CC, Blaschke TF. 2000. Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans. J. Clin. Pharmacol. 40:803-14
-
(2000)
J. Clin. Pharmacol
, vol.40
, pp. 803-814
-
-
Lesko, L.J.1
Rowland, M.2
Peck, C.C.3
Blaschke, T.F.4
-
46
-
-
0033623142
-
In vivo drug-drug interaction studies-a survey of all new molecular entities approved from 1987 to 1997
-
Marroum P, Uppoor R, Parmelee T, Ajayi F, Burnett A, et al. 2000. In vivo drug-drug interaction studies-a survey of all new molecular entities approved from 1987 to 1997. Clin. Pharmacol. Ther. 68:280-85
-
(2000)
Clin. Pharmacol. Ther
, vol.68
, pp. 280-285
-
-
Marroum, P.1
Uppoor, R.2
Parmelee, T.3
Ajayi, F.4
Burnett, A.5
-
47
-
-
33846620242
-
The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program
-
Orr MS, Goodsaid F, Amur S, Rudman A, Frueh FW. 2007. The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program. Clin. Pharmacol. Ther. 81:294-97
-
(2007)
Clin. Pharmacol. Ther
, vol.81
, pp. 294-297
-
-
Orr, M.S.1
Goodsaid, F.2
Amur, S.3
Rudman, A.4
Frueh, F.W.5
-
48
-
-
34047177929
-
Biomarker qualification pilot process at theUSFood andDrugAdministration
-
Goodsaid F, Frueh F. 2007. Biomarker qualification pilot process at theUSFood andDrugAdministration. AAPS J. 9:E105-8
-
(2007)
AAPS J
, vol.9
-
-
Goodsaid, F.1
Frueh, F.2
-
49
-
-
0026671408
-
Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin
-
Honig PK, Woosley RL, Zamani K, Conner DP, Cantilena LRJ. 1992. Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clin. Pharmacol. Ther. 52:231-38
-
(1992)
Clin. Pharmacol. Ther
, vol.52
, pp. 231-238
-
-
Honig, P.K.1
Woosley, R.L.2
Zamani, K.3
Conner, D.P.4
Lrj, C.5
-
50
-
-
0027162542
-
Effect of concomitant administration of cimetidine and ranitidine on the pharmacokinetics and electrocardiographic effects of terfenadine
-
Honig PK, Wortham DC, Zamani K, Conner DP, Mullin JC, Cantilena LR. 1993. Effect of concomitant administration of cimetidine and ranitidine on the pharmacokinetics and electrocardiographic effects of terfenadine. Eur. J. Clin. Pharmacol. 45:41-46
-
(1993)
Eur. J. Clin. Pharmacol
, vol.45
, pp. 41-46
-
-
Honig, P.K.1
Wortham, D.C.2
Zamani, K.3
Conner, D.P.4
Mullin, J.C.5
Cantilena, L.R.6
-
51
-
-
0027231225
-
The effect of fluconazole on the steady-state pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine in humans
-
Honig PK, Wortham DC, Zamani K, Mullin JC, Conner DP, Cantilena LR. 1993. The effect of fluconazole on the steady-state pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine in humans. Clin. Pharmacol. Ther. 53:630-36
-
(1993)
Clin. Pharmacol. Ther
, vol.53
, pp. 630-636
-
-
Honig, P.K.1
Wortham, D.C.2
Zamani, K.3
Mullin, J.C.4
Conner, D.P.5
Cantilena, L.R.6
-
52
-
-
0027468346
-
Terfenadineketoconazole interaction: Pharmacokinetic and electrocardiographic consequences
-
Honig PK, Wortham DC, Zamani K, Conner DP, Mullin JC, Cantilena LR. 1993. Terfenadineketoconazole interaction: pharmacokinetic and electrocardiographic consequences. JAMA 269:1513-18
-
(1993)
JAMA
, vol.269
, pp. 1513-1518
-
-
Honig, P.K.1
Wortham, D.C.2
Zamani, K.3
Conner, D.P.4
Mullin, J.C.5
Cantilena, L.R.6
-
53
-
-
0029879317
-
Grapefruit juice alters the systemic bioavailability and cardiac repolarization of terfenadine in poor metabolizers of terfenadine
-
Honig PK, Wortham DC, Lazarev A, Cantilena LR. 1996. Grapefruit juice alters the systemic bioavailability and cardiac repolarization of terfenadine in poor metabolizers of terfenadine. J. Clin. Pharmacol. 36:345-51
-
(1996)
J. Clin. Pharmacol
, vol.36
, pp. 345-351
-
-
Honig, P.K.1
Wortham, D.C.2
Lazarev, A.3
Cantilena, L.R.4
-
54
-
-
0026504422
-
Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development
-
Peck CC, Barr WH, Benet LZ, Collins J, Desjardins RE, et al. 1992. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Clin. Pharmacol. Ther. 51:465-73
-
(1992)
Clin. Pharmacol. Ther
, vol.51
, pp. 465-473
-
-
Peck, C.C.1
Barr, W.H.2
Benet, L.Z.3
Collins, J.4
Desjardins, R.E.5
-
55
-
-
1542440937
-
Current regulatory policies regarding pediatric indications and exclusivity
-
Rodriguez WJ, Roberts R, Murphy D. 2003. Current regulatory policies regarding pediatric indications and exclusivity. J. Pediatr. Gastroenterol. Nutr. 37(Suppl. 1):S40-45
-
(2003)
J. Pediatr. Gastroenterol. Nutr
, vol.37
, Issue.SUPPL. 1
-
-
Rodriguez, W.J.1
Roberts, R.2
Murphy, D.3
-
56
-
-
40949096097
-
Improving pediatric dosing through pediatric initiatives: What we have learned
-
Rodriguez W, Selen A, Avant D, Chaurasia C, Crescenzi T, et al. 2008. Improving pediatric dosing through pediatric initiatives: what we have learned. Pediatrics 121:530-39
-
(2008)
Pediatrics
, vol.121
, pp. 530-539
-
-
Rodriguez, W.1
Selen, A.2
Avant, D.3
Chaurasia, C.4
Crescenzi, T.5
-
57
-
-
0038117616
-
Central ethical dilemmas in research involving children
-
Tauer CA. 2002. Central ethical dilemmas in research involving children. Account. Res. 9:127-42
-
(2002)
Account. Res
, vol.9
, pp. 127-142
-
-
Tauer, C.A.1
-
59
-
-
2542641907
-
-
US Food Drug Admin Chall. Oppor.Rep., March 2004, US Food Drug Admin., Silver Spring,MD
-
USFood Drug Admin. 2004. Innovation or stagnation: challenge and opportunity on the critical path to new medical products.Chall. Oppor.Rep., March 2004, US Food Drug Admin., Silver Spring,MD. http://www.fda. gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ CriticalPathOpportunitiesReports/ucm077262.htm
-
(2004)
Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products
-
-
-
60
-
-
77951441171
-
The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science
-
Woosley RL, Myers RT, Goodsaid F. 2010. The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science. Clin. Pharmacol. Ther. 87:530-33
-
(2010)
Clin. Pharmacol. Ther
, vol.87
, pp. 530-533
-
-
Woosley, R.L.1
Myers, R.T.2
Goodsaid, F.3
-
61
-
-
79951884999
-
-
US Dep. Health Hum. Serv., US Food Drug Admin., Cent. Drug Eval. Res Oct. 2010, US Food Drug Admin., Silver Spring, MD
-
US Dep. Health Hum. Serv., US Food Drug Admin., Cent. Drug Eval. Res. 2010. Guidance for industry: qualification process for drug development tools. Oct. 2010, US Food Drug Admin., Silver Spring, MD. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf
-
(2010)
Guidance for Industry: Qualification Process for Drug Development Tools
-
-
-
62
-
-
77952138048
-
Renal biomarker qualification submission: A dialog between the FDA-EMEA and Predictive Safety Testing Consortium
-
Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, et al. 2010. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat. Biotechnol. 28:455-62
-
(2010)
Nat. Biotechnol
, vol.28
, pp. 455-462
-
-
Dieterle, F.1
Sistare, F.2
Goodsaid, F.3
Papaluca, M.4
Ozer, J.S.5
-
63
-
-
37049026266
-
The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path
-
Goodsaid F, Frueh F, Mattes W. 2007. The Predictive Safety Testing Consortium: a synthesis of the goals, challenges and accomplishments of the Critical Path. Drug Discov. Today Technol. 4:47-50
-
(2007)
Drug Discov. Today Technol
, vol.4
, pp. 47-50
-
-
Goodsaid, F.1
Frueh, F.2
Mattes, W.3
-
64
-
-
84872230643
-
PDUFA: A lot of talk
-
June 6
-
Usdin S. 2011. PDUFA: a lot of talk. BioCentury, June 6. http://www.biocentury.com/biotech-pharmanews/coverstory/2011-06-06/ its-about-meetings-not-money-a1
-
(2011)
BioCentury
-
-
Usdin, S.1
-
66
-
-
84872230818
-
-
US Food Drug Admin US Food Drug Admin., Apr 9
-
US Food Drug Admin. 2008. FDA appoints Dr. Frank M. Torti to senior leadership position. US Food Drug Admin., Apr. 9. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/2008/ucm116877.htm
-
(2008)
FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
-
-
-
67
-
-
84855594900
-
-
US Food Drug Admin Strateg. Plan, Aug 2011, US Food Drug Admin., Silver Spring MD
-
US Food Drug Admin. 2011. Advancing regulatory science at FDA. Strateg. Plan, Aug. 2011, US Food Drug Admin., Silver Spring, MD. http://www.fda.gov/ scienceresearch/specialtopics/regulatoryscience/ucm267719.htm
-
(2011)
Advancing Regulatory Science at FDA
-
-
-
68
-
-
84857216350
-
-
US Food Drug Admin Oct 2011, US Food Drug Admin., Silver Spring MD
-
US Food Drug Admin. 2011. Driving biomedical innovation: initiatives to improve products for patients. Oct. 2011, US Food Drug Admin., Silver Spring, MD. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM274464. pdf
-
(2011)
Driving Biomedical Innovation: Initiatives to Improve Products for Patients
-
-
-
71
-
-
80055023058
-
Integration of diverse data sources for prediction of adverse drug events
-
Abernethy DR, Bai JP, Burkhart K, Xie HG, Zhichkin P. 2011. Integration of diverse data sources for prediction of adverse drug events. Clin. Pharmacol. Ther. 90:645-46
-
(2011)
Clin. Pharmacol. Ther
, vol.90
, pp. 645-646
-
-
Abernethy, D.R.1
Bai, J.P.2
Burkhart, K.3
Xie, H.G.4
Zhichkin, P.5
-
72
-
-
78349257470
-
Phase III clinical trial development: A process of chutes and ladders
-
Dilts DM, Cheng SK, Crites JS, Sandler AB, Doroshow JH. 2010. Phase III clinical trial development: a process of chutes and ladders. Clin. Cancer Res. 16:5381-89
-
(2010)
Clin. Cancer Res
, vol.16
, pp. 5381-5389
-
-
Dilts, D.M.1
Cheng, S.K.2
Crites, J.S.3
Sandler, A.B.4
Doroshow, J.H.5
-
73
-
-
77954603767
-
Evidence-based medicine-engineering the Learning Healthcare System
-
McGinnis JM. 2010. Evidence-based medicine-engineering the Learning Healthcare System. Stud. Health Technol. Inform. 153:145-57
-
(2010)
Stud. Health Technol. Inform
, vol.153
, pp. 145-157
-
-
McGinnis, J.M.1
-
74
-
-
84872250510
-
Digital Pharma: Pfizer's mobile-powered 'virtual' clinical trial
-
Aug 6
-
Tyer D. 2011. Digital Pharma: Pfizer's mobile-powered 'virtual' clinical trial. InPharm, Aug. 6. http://www.inpharm.com/news/159024/digital-pharma- pfizer-virtual-clinical-trial
-
(2011)
InPharm
-
-
Tyer, D.1
-
75
-
-
20344397006
-
-
US Food Drug Admin US Food Drug Admin., Silver Spring, MD
-
US Food Drug Admin. 2005. Drug-diagnostic co-development concept paper. US Food Drug Admin., Silver Spring, MD. http://www.fda.gov/downloads/Drugs/ ScienceResearch/ResearchAreas/Pharmacogenetics/UCM116689.pdf
-
(2005)
Drug-diagnostic Co-development Concept Paper
-
-
-
76
-
-
84857205702
-
Is it possible for FDA regulatory scientists and industry scientists to work together?
-
Woosley RL. 2012. Is it possible for FDA regulatory scientists and industry scientists to work together? Clin. Pharmacol. Ther. 91:390-92
-
(2012)
Clin. Pharmacol. Ther
, vol.91
, pp. 390-392
-
-
Woosley, R.L.1
-
78
-
-
70149095955
-
2009 Biospecimen Research Network Symposium: Advancing cancer research through biospecimen science
-
Moore HM, Compton CC, Lim MD, Vaught J, Christiansen KN, Alper J. 2009. 2009 Biospecimen Research Network Symposium: advancing cancer research through biospecimen science. Cancer Res. 69:6770-72
-
(2009)
Cancer Res
, vol.69
, pp. 6770-6772
-
-
Moore, H.M.1
Compton, C.C.2
Lim, M.D.3
Vaught, J.4
Christiansen, K.N.5
Alper, J.6
-
79
-
-
77952477706
-
Inter-laboratory variation in cerebrospinal fluid biomarkers for Alzheimer's disease: United we stand, divided we fall
-
Mattsson N, Blennow K, Zetterberg H. 2010. Inter-laboratory variation in cerebrospinal fluid biomarkers for Alzheimer's disease: United we stand, divided we fall. Clin. Chem. Lab. Med. 48:603-7
-
(2010)
Clin. Chem. Lab. Med
, vol.48
, pp. 603-607
-
-
Mattsson, N.1
Blennow, K.2
Zetterberg, H.3
-
80
-
-
84859818549
-
Invited response to: Preparedness of the CTSA's structural and scientific assets to support the mission of the National Center for Advancing Translational Sciences (NCATS)
-
Insel TR. 2012. Invited response to: Preparedness of the CTSA's structural and scientific assets to support the mission of the National Center for Advancing Translational Sciences (NCATS). Clin. Transl. Sci. 5:130-31
-
(2012)
Clin. Transl. Sci
, vol.5
, pp. 130-131
-
-
Insel, T.R.1
-
81
-
-
84872242371
-
-
US Food Drug Admin US Food Drug Admin., Oct 11
-
US Food Drug Admin. 2011. FDA-CMS Parallel Review. US Food Drug Admin., Oct. 11. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/ucm255678.htm
-
(2011)
FDA-CMS Parallel Review
-
-
|