-
1
-
-
74549144459
-
-
FDA wesite: http://www.fda.gov/oc/initiatives/criticalpath/woodcock0602/ woodcock0602.html
-
FDA's Critical Path Initiative. Woodcock J, 2004 FDA wesite: http://www.fda.gov/oc/initiatives/criticalpath/woodcock0602/woodcock0602.html
-
(2004)
FDA's Critical Path Initiative
-
-
Woodcock, J.1
-
2
-
-
34548827478
-
-
Chapman and Hall/CRC Press, Taylor and Francis, New York, New York
-
Adaptive Design Methods in Clinical Trials. Chow SC, Chang M, Chapman and Hall/CRC Press, Taylor and Francis, New York, New York 2006
-
(2006)
Adaptive Design Methods in Clinical Trials
-
-
Chow, S.C.1
Chang, M.2
-
3
-
-
44949171503
-
Adaptive design methods in clinical trials
-
10.1186/1750-1172-3-11
-
Adaptive design methods in clinical trials. Chow SC, Chang M, The Orphanet Journal of Rare Diseases 2008 3 11 10.1186/1750-1172-3-11
-
(2008)
The Orphanet Journal of Rare Diseases
, vol.3
, pp. 11
-
-
Chow, S.C.1
Chang, M.2
-
5
-
-
78249249606
-
Viewpoints on the FDA draft adaptive designs guidance from the PhRMA Working Group (with discussions)
-
10.1080/10543406.2010.514452 21058107
-
Viewpoints on the FDA draft adaptive designs guidance from the PhRMA Working Group (with discussions). Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J, Journal of Biopharmaceutical Statistics 2010 20 6 1115 1124 10.1080/10543406.2010.514452 21058107
-
(2010)
Journal of Biopharmaceutical Statistics
, vol.20
, Issue.6
, pp. 1115-1124
-
-
Gallo, P.1
Chuang-Stein, C.2
Dragalin, V.3
Gaydos, B.4
Krams, M.5
Pinheiro, J.6
-
6
-
-
22044434097
-
Statistical consideration of adaptive methods in clinical development
-
DOI 10.1081/BIP-200062277
-
Statistical consideration of adaptive methods in clinical development. Chow SC, Chang M, Pong A, Journal of Biopharmaceutical Statistics 2005 15 575 591 10.1081/BIP-200062277 16022164 (Pubitemid 40967300)
-
(2005)
Journal of Biopharmaceutical Statistics
, vol.15
, Issue.4
, pp. 575-591
-
-
Chow, S.-C.1
Chang, M.2
Pong, A.3
-
7
-
-
33646245937
-
Adaptive design in clinical drug development - An executive summary of the PhRMA Working Group (with discussions)
-
10.1080/10543400600614742 16724485
-
Adaptive design in clinical drug development-an executive summary of the PhRMA Working Group (with discussions). Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J, Journal of Biopharmaceutical Statistics 2006 16 3 275 283 10.1080/10543400600614742 16724485
-
(2006)
Journal of Biopharmaceutical Statistics
, vol.16
, Issue.3
, pp. 275-283
-
-
Gallo, P.1
Chuang-Stein, C.2
Dragalin, V.3
Gaydos, B.4
Krams, M.5
Pinheiro, J.6
-
10
-
-
34249883557
-
Adaptive design method based on sum of p-values
-
DOI 10.1002/sim.2755
-
Adaptive design method based on sum of p-values. Chang M, Statistics in Medicine 2007 26 2772 2784 10.1002/sim.2755 17133651 (Pubitemid 46865098)
-
(2007)
Statistics in Medicine
, vol.26
, Issue.14
, pp. 2772-2784
-
-
Chang, M.1
-
11
-
-
0018687930
-
A multiple testing procedure for clinical trials
-
DOI 10.2307/2530245
-
A multiple testing procedure for clinical trials. O'Brien PC, Fleming TR, Biometrics 1979 35 549 556 10.2307/2530245 497341 (Pubitemid 10242750)
-
(1979)
Biometrics
, vol.35
, Issue.3
, pp. 549-556
-
-
O'Brien, P.C.1
Fleming, T.R.2
-
13
-
-
33750893179
-
Implementing adaptive designs: Logistical and operational considerations
-
Implementing adaptive designs: logistical and operational considerations. Quinlan JA, Krams M, Drug Information Journal 2006 40 4 437 444 (Pubitemid 44721121)
-
(2006)
Drug Information Journal
, vol.40
, Issue.4
, pp. 437-444
-
-
Quinlan, J.A.1
Krams, M.2
-
15
-
-
84855307509
-
Adaptive trial design - FDA statistical reviewer's view
-
Adaptive trial design-FDA statistical reviewer's view. Li N, Presented at the CRT 2006 Workshop with the FDA, Arlington, Virginia, April 4, 2006 2006
-
(2006)
Presented at the CRT 2006 Workshop with the FDA, Arlington, Virginia, April 4, 2006
-
-
Li, N.1
-
16
-
-
84855312615
-
Adaptive trial design - FDA view
-
Adaptive trial design-FDA view. Uchida T, Presented at the CRT 2006 Workshop with the FDA, Arlington, Virginia, April 4, 2006 2006
-
(2006)
Presented at the CRT 2006 Workshop with the FDA, Arlington, Virginia, April 4, 2006
-
-
Uchida, T.1
-
18
-
-
33750854113
-
Adaptive seamless phase II/III designs - Background, operational aspects, and examples
-
Adaptive seamless phase II/III designs-background, operational aspects, and examples. Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M, Drug Information Journal 2006 40 463 474
-
(2006)
Drug Information Journal
, vol.40
, pp. 463-474
-
-
MacA, J.1
Bhattacharya, S.2
Dragalin, V.3
Gallo, P.4
Krams, M.5
-
20
-
-
84855308087
-
Clinical trial simulation
-
Marcel Dekker, Inc. New York, New York Chow SC
-
Clinical trial simulation. Li HI, Lai PY, Encyclopedia of Biopharmaceutical Statistics Marcel Dekker, Inc. New York, New York, Chow SC, 2003 200 201
-
(2003)
Encyclopedia of Biopharmaceutical Statistics
, pp. 200-201
-
-
Li, H.I.1
Lai, P.Y.2
-
21
-
-
85055371742
-
-
Chapman and Hall/CRC Press, Taylor & Francis, New York, New York
-
Chang M, Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies Chapman and Hall/CRC Press, Taylor & Francis, New York, New York 2010
-
(2010)
Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies
-
-
Chang, M.1
-
22
-
-
84855322470
-
Clinical Trial Design with ExpDesign Studio
-
http://www.ctrisoft.net
-
Clinical Trial Design with ExpDesign Studio. CTriSoft Intl, Boston, MA 2002 http://www.ctrisoft.net
-
(2002)
Boston, MA
-
-
Intl, C.1
-
24
-
-
84855312617
-
-
Chapman and Hall/CRC Press, Taylor & Francis, New York, New York
-
Pong A, Chow SC, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development Chapman and Hall/CRC Press, Taylor & Francis, New York, New York 2010
-
(2010)
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
-
-
Pong, A.1
Chow, S.C.2
-
25
-
-
33748560822
-
A brief review on software developments for group sequential and adaptive designs
-
DOI 10.1002/bimj.200510233
-
A brief review on software development for group sequential and adaptive designs. Wassmer G, Vandemeulebroecke M, Biometrical Journal 2006 48 732 737 10.1002/bimj.200510233 16972726 (Pubitemid 44367921)
-
(2006)
Biometrical Journal
, vol.48
, Issue.4
, pp. 732-737
-
-
Wassmer, G.1
Vandemeulebroecke, M.2
|