-
1
-
-
80051818398
-
-
US FDA. Federal Food, Drug, and Cosmetic (FD&C) Act, chapter V: drugs and devices, (accessed May 7)
-
US FDA. Federal Food, Drug, and Cosmetic (FD&C) Act, chapter V: drugs and devices. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandC osmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm (accessed May 7, 2010).
-
(2010)
-
-
-
2
-
-
80051809001
-
-
US FDA. Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products. May, 1998 (accessed May 7)
-
US FDA. Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products. May 1998. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/UCM 078749.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
3
-
-
80051821427
-
-
(accessed May 7).US FDA. Draft guidance for industry: integrated summary of effectiveness. August 2008.
-
US FDA. Draft guidance for industry: integrated summary of effectiveness. August 2008. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/UCM079803.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
4
-
-
80051821943
-
-
US FDA. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. May 2007, (accessed May 7)
-
US FDA. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. May 2007. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula toryInformation/Guidances/UCM071590.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
5
-
-
0035997112
-
Substantial evidence of effect
-
Gould AL. Substantial evidence of effect. J Biopharm Stat. 2002;12:53-77.
-
(2002)
J Biopharm Stat
, vol.12
, pp. 53-77
-
-
Gould, A.L.1
-
6
-
-
80051804814
-
-
US FDA. Taxotere (docetaxel) label, (accessed May 7)
-
US FDA. Taxotere (docetaxel) label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s044lbl.p df (accessed May 7, 2010).
-
(2010)
-
-
-
7
-
-
0020078179
-
A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results
-
A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982;247:1707-1714.
-
(1982)
JAMA
, vol.247
, pp. 1707-1714
-
-
-
8
-
-
0023805341
-
ISIS-2 (Second International Study of Infarct Survival) Collaborative, Group., Randomised trial of intravenous streptokinase, oral aspirin, both or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2
-
ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988;2 (8607):349-360.
-
(1988)
Lancet
, vol.2
, Issue.8607
, pp. 349-360
-
-
-
9
-
-
80051811307
-
-
US FDA. Victoza (liraglutide) label, (accessed May 7)
-
US FDA. Victoza (liraglutide) label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
10
-
-
80051818151
-
-
US FDA. Drugs @ FDA, (accessed August 10)
-
US FDA. Drugs @ FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/(accessed August 10, 2010).
-
(2010)
-
-
-
11
-
-
80051807596
-
-
Code of Federal Regulations. Title 21 Food and Drugs. Part 314.126, (accessed May 7)
-
Code of Federal Regulations. Title 21 Food and Drugs. Part 314.126. http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr314.126.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
12
-
-
80051817891
-
-
NDA/demonstrating product effectiveness. Presentation at Unapproved Drugs Workshop, January 9, 1977 (accessed May 7)
-
Temple RJ. NDA/demonstrating product effectiveness. Presentation at Unapproved Drugs Workshop, January 9, 1977. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapproved Drugs/ucm120000.pdf (accessed May 7, 2010).
-
(2010)
-
-
Temple, R.J.1
-
13
-
-
80051819956
-
-
ICH. ICH E9, statistical principles for clinical trials, (accessed May 7)
-
ICH. ICH E9, statistical principles for clinical trials. http://www.ich.org/LOB/media/MEDIA485.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
14
-
-
80051811153
-
-
US FDA. Draft guidance for industry: noninferiority clinical trials. March 2010, (accessed August 11)
-
US FDA. Draft guidance for industry: noninferiority clinical trials. March 2010. http://www.fda.gov/downloads/Drugs/GuidanceCom plianceRegulatoryInformation/Guidances/UCM202140.pdf (accessed August 11, 2010).
-
(2010)
-
-
-
15
-
-
80051808319
-
-
ICH. ICH E10, choice of control group and related issues in clinical trials, (accessed May 7)
-
ICH. ICH E10, choice of control group and related issues in clinical trials. http://www.ich.org/LOB/media/MEDIA486.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
16
-
-
34548291867
-
Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs
-
Powers JH. Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs. Clin Trials Antimicrobials. 2007;45(Suppl 2):S153- S161.
-
(2007)
Clin Trials Antimicrobials
, vol.45
, Issue.SUPPL. 2
-
-
Powers, J.H.1
-
18
-
-
0019328346
-
The FDA's critique of the anturane reinfarction trial
-
Temple R, Pledger G. The FDA's critique of the anturane reinfarction trial. N Engl J Med. 1980; 303:1488-1492.
-
(1980)
N Engl J Med
, vol.303
, pp. 1488-1492
-
-
Temple, R.1
Pledger, G.2
-
19
-
-
0036378736
-
Report of a workshop on confirmatory evidence to support a single clinical trial as a basis for new drug approval
-
Peck CC, Wechsler J. Report of a workshop on confirmatory evidence to support a single clinical trial as a basis for new drug approval. Drug Inf J. 2002;36:517-534.
-
(2002)
Drug Inf J
, vol.36
, pp. 517-534
-
-
Peck, C.C.1
Wechsler, J.2
-
22
-
-
80051807080
-
-
Expert report, July 31, 2008 (accessed May 7)
-
Kessler DA. Expert report, July 31, 2008. http://www.pharmalot.com/wp-content/uploads/2008/10/neurontin-kessler.pd f (accessed May 7, 2010).
-
(2010)
-
-
Kessler, D.A.1
-
23
-
-
80051809259
-
-
Code of Federal Regulations. Title 21 Food and Drugs. Part 202, (accessed May 7)
-
Code of Federal Regulations. Title 21 Food and Drugs. Part 202. http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr202.1.pdf (accessed May 7, 2010).
-
(2010)
-
-
-
24
-
-
80051812737
-
-
US FDA. Warning letters and notice of violation letters to pharmaceutical companies, (accessed May 7)
-
US FDA. Warning letters and notice of violation letters to pharmaceutical companies. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Enforce mentActivitiesby FDA/WarningLettersandNoticeofViolationLet terstoPharmaceuticalCompanies/default.htm (accessed May 7, 2010).
-
(2010)
-
-
|