-
1
-
-
79959416954
-
-
US Food and Drug Administration
-
US Food and Drug Administration. Advancing Regulatory Science for Public Health http://www.fda.gov/downloads/ScienceResearch/Specialtopics/Regulatory Science/UcM228444.pdf (2010).
-
(2010)
Advancing Regulatory Science for Public Health
-
-
-
4
-
-
84872219250
-
-
16 March 2011
-
http://www. ema.europa.eu/ema/index.jsp?curl=pages/includes/document/ document-detail.jsp?webcontentId=Wc500103621 & mid=Wc0b01ac058009a3dc (16 March 2011).
-
-
-
-
5
-
-
1542333321
-
-
US Food and Drug Administration March 2005
-
US Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions http://www.fda.gov/downloads/Drugs/ GuidancecomplianceRegulatoryInformation/Guidances/UcM079849.pdf (March 2005)
-
Guidance for Industry: Pharmacogenomic Data Submissions
-
-
-
8
-
-
84872220932
-
-
US Food and Drug Administration 5 March 2012
-
US Food and Drug Administration. Biomarker Qualifcation Program http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugDevelopmenttoolsQualifcationProgram/ucm284076.htm (5 March 2012).
-
Biomarker Qualifcation Program
-
-
-
9
-
-
84872221227
-
-
US Food and Drug Administration 14 April 2008
-
US Food and Drug Administration. Letter from Janet Woodcock and John Jenkins to Frank Dieterle et al. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DrugDevelopmenttoolsQualifcationProgram/UcM285031. pdf (14 April 2008).
-
Letter from Janet Woodcock and John Jenkins to Frank Dieterle et Al
-
-
-
11
-
-
84855631700
-
-
US Food and Drug Administration 11 November 2010
-
US Food and Drug Administration. Predictive Safety testing consortium (PStc) http://www.fda.gov/AboutFDA/Partnershipscollaborations/ PublicPrivatePartnershipProgram/ucm231132.htm (11 November 2010).
-
Predictive Safety Testing Consortium (PStc)
-
-
-
12
-
-
50449104247
-
Developing new drugs for the treatment of drug-resistant tuberculosis: A regulatory perspective
-
Sacks, L.V. & Behrman, R.E. Developing new drugs for the treatment of drug-resistant tuberculosis: a regulatory perspective. Tuberculosis 99 (suppl. 1), S93-100 (2008).
-
(2008)
Tuberculosis
, vol.99
, Issue.SUPPL. 1
-
-
Sacks, L.V.1
Behrman, R.E.2
-
13
-
-
84872206042
-
-
Critical Path Institute. critical Path to tB Drug Regimens (cPtR)
-
Critical Path Institute. critical Path to tB Drug Regimens (cPtR) http://www.c-path.org/cPtR.cfm.
-
-
-
-
14
-
-
84872217490
-
-
23 June 2010
-
Goodman, J. Statement before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, committee on Appropriations, US Senate http://www.fda.gov/NewsEvents/testimony/ucm216991.htm (23 June 2010).
-
Statement before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations, US Senate
-
-
Goodman, J.1
-
17
-
-
84862777400
-
Adaptive licensing: Taking the next step in the evolution of drug approval
-
Eichler, H.G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426-437 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 426-437
-
-
Eichler, H.G.1
-
19
-
-
77952819564
-
Validation of statistical signal detection procedures in EudraVigilance post-authorization data: A retrospective evaluation of the potential for earlier signalling
-
Alvarez, Y., Hidalgo, A., Maignen, F. & Slattery, J. Validation of statistical signal detection procedures in EudraVigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling. Drug Saf. 33, 475-487 (2010).
-
(2010)
Drug Saf
, vol.33
, pp. 475-487
-
-
Alvarez, Y.1
Hidalgo, A.2
Maignen, F.3
Slattery, J.4
-
20
-
-
79955422795
-
European perspective on risk management and drug safety
-
Raine, J., Wise, L., Blackburn, S., Eichler, H.G. & Breckenridge, A. European perspective on risk management and drug safety. Clin. Pharmacol. Ther. 89, 650-654 (2011).
-
(2011)
Clin. Pharmacol. Ther.
, vol.89
, pp. 650-654
-
-
Raine, J.1
Wise, L.2
Blackburn, S.3
Eichler, H.G.4
Breckenridge, A.5
-
22
-
-
84872215550
-
ENcePP: Where are we and where are we going?
-
16 June 2011
-
Smeraldi, C. ENcePP: Where Are We and Where are We Going? European Medicines Agency http://www.ema.europa.eu/docs/en-GB/document-library/ Presentation/2011/11/Wc500117945.pdf (16 June 2011).
-
European Medicines Agency
-
-
Smeraldi, C.1
-
25
-
-
84857237851
-
The innovative medicines initiative: A European response to the innovation challenge
-
Goldman, M. the innovative medicines initiative: a European response to the innovation challenge. Clin. Pharmacol. Ther. 91, 418-425 (2012).
-
(2012)
Clin. Pharmacol. Ther.
, vol.91
, pp. 418-425
-
-
Goldman, M.1
-
26
-
-
39649084919
-
The FDA critical path initiative and its infuence on new drug development
-
Woodcock, J. & Woosley, R. the FDA critical path initiative and its infuence on new drug development. Annu. Rev. Med. 59, 1-12 (2008).
-
(2008)
Annu. Rev. Med.
, vol.59
, pp. 1-12
-
-
Woodcock, J.1
Woosley, R.2
|