-
1
-
-
45749146622
-
PhRMA white paper on ADME pharmacogenomics
-
DOI 10.1177/0091270008319329
-
Williams, J.A. et al. PhRMA white paper on ADME pharmacogenomics. J. Clin. Pharmacol. 48, 849-889 (2008). (Pubitemid 351871964)
-
(2008)
Journal of Clinical Pharmacology
, vol.48
, Issue.7
, pp. 849-889
-
-
Williams, J.A.1
Andersson, T.2
Andersson, T.B.3
Blanchard, R.4
Behm, M.O.5
Cohen, N.6
Edeki, T.7
Franc, M.8
Hillgren, K.M.9
Johnson, K.J.10
Katz, D.A.11
Milton, M.N.12
Murray, B.P.13
Polli, J.W.14
Ricci, D.15
Shipley, L.A.16
Vangala, S.17
Wrighton, S.A.18
-
5
-
-
73349091534
-
A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease
-
Bapineuzumab 201 Clinical Trial Investigators
-
Salloway, S. et al.; Bapineuzumab 201 Clinical Trial Investigators. A phase 2 multiple ascending dose trial of bapineuzumab in mild to moderate Alzheimer disease. Neurology 73, 2061-2070 (2009).
-
(2009)
Neurology
, vol.73
, pp. 2061-2070
-
-
Salloway, S.1
-
6
-
-
84858320421
-
-
US Food and Drug Administration
-
US Food and Drug Administration. Cetuximab (Erbitux) and panitumumab (Vectibix),http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm172905.htm (2009).
-
(2009)
Cetuximab (Erbitux) and Panitumumab (Vectibix)
-
-
-
7
-
-
77956090575
-
Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: Results from a randomized, double-blind, placebo-controlled phase III study
-
Gold, M. et al. Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: results from a randomized, double-blind, placebo-controlled phase III study. Dement. Geriatr. Cogn. Disord. 30, 131-146 (2010).
-
(2010)
Dement. Geriatr. Cogn. Disord.
, vol.30
, pp. 131-146
-
-
Gold, M.1
-
8
-
-
79952991837
-
Challenges in obtaining adequate genetic sample sets in clinical trials: The perspective of the industry pharmacogenomics working group
-
Warner, A.W. et al. Challenges in obtaining adequate genetic sample sets in clinical trials: the perspective of the industry pharmacogenomics working group. Clin. Pharmacol. Ther. 89, 529-536 (2011).
-
(2011)
Clin. Pharmacol. Ther.
, vol.89
, pp. 529-536
-
-
Warner, A.W.1
-
9
-
-
79952993123
-
Current practices for DNA sample collection and storage in the pharmaceutical industry, and potential areas for harmonization: Perspective of the I-PWG
-
Franc, M.A., Warner, A.W., Cohen, N., Shaw, P.M., Groenen, P. & Snapir, A. Current practices for DNA sample collection and storage in the pharmaceutical industry, and potential areas for harmonization: perspective of the I-PWG. Clin. Pharmacol. Ther. 89, 546-553 (2011).
-
(2011)
Clin. Pharmacol. Ther.
, vol.89
, pp. 546-553
-
-
Franc, M.A.1
Warner, A.W.2
Cohen, N.3
Shaw, P.M.4
Groenen, P.5
Snapir, A.6
-
10
-
-
1542333321
-
-
US Food and Drug Administration
-
US Food and Drug Administration. Guidance for Industry-Pharmacogenomic Data Submissions,http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ UCM126957.pdf (2005).
-
(2005)
Guidance for Industry-Pharmacogenomic Data Submissions
-
-
-
11
-
-
84872209996
-
-
Good Laboratory Practice for Nonclinical Laboratory Studies
-
US Code of Federal Regulations 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies)http://www.access.gpo.gov/nara/cfr/waisidx- 09/21cfr58-09.html.
-
US Code of Federal Regulations 21 CFR Part 58
-
-
-
12
-
-
85081447678
-
-
CLIA Subpart E
-
CLIA 42 CFR Part 493 Subpart E .http://wwwn.cdc.gov/clia/pdf/42cfr493- 2004.pdf.
-
CFR
, vol.42
, Issue.PART 493
-
-
-
15
-
-
79960831858
-
Prospective-retrospective biomarker analysis for regulatory consideration: White paper from the industry pharmacogenomics working group
-
Patterson, S.D. et al. Prospective-retrospective biomarker analysis for regulatory consideration: white paper from the industry pharmacogenomics working group. Pharmacogenomics 12, 939-951 (2011).
-
(2011)
Pharmacogenomics
, vol.12
, pp. 939-951
-
-
Patterson, S.D.1
-
16
-
-
77149134011
-
Deconstructing the drug development process: The new face of innovation
-
Kaitlin, K.I. Deconstructing the drug development process: the new face of innovation. Clin. Pharmacol. Ther. 87, 356-361 (2010).
-
(2010)
Clin. Pharmacol. Ther.
, vol.87
, pp. 356-361
-
-
Kaitlin, K.I.1
-
19
-
-
77954827460
-
The path to personalized medicine
-
Hamburg, M.A. & Collins, F.S. The path to personalized medicine. N. Engl. J. Med. 363, 301-304 (2010).
-
(2010)
N. Engl. J. Med.
, vol.363
, pp. 301-304
-
-
Hamburg, M.A.1
Collins, F.S.2
-
20
-
-
79952254324
-
-
US Food and Drug Administration
-
US Food and Drug Administration Table of Pharmacogenomic Biomarkers in Drug Labels,http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ Pharmacogenetics/ucm083378.htm .
-
Table of Pharmacogenomic Biomarkers in Drug Labels
-
-
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