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Items: 1 to 20 of 169

1.

Bayesian statistics in medical devices: innovation sparked by the FDA.

Campbell G.

J Biopharm Stat. 2011 Sep;21(5):871-87. doi: 10.1080/10543406.2011.589638.

PMID:
21830920
2.

Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting.

Bonangelino P, Irony T, Liang S, Li X, Mukhi V, Ruan S, Xu Y, Yang X, Wang C.

J Biopharm Stat. 2011 Sep;21(5):938-53. doi: 10.1080/10543406.2011.589650.

PMID:
21830924
3.

Experience with reviewing Bayesian medical device trials.

Pennello G, Thompson L.

J Biopharm Stat. 2008;18(1):81-115.

PMID:
18161543
4.

Statistical innovations in the medical device world sparked by the FDA.

Campbell G, Yue LQ.

J Biopharm Stat. 2016;26(1):3-16. doi: 10.1080/10543406.2015.1092037. Review.

PMID:
26372890
5.

Practical Bayesian design and analysis for drug and device clinical trials.

Hobbs BP, Carlin BP.

J Biopharm Stat. 2008;18(1):54-80.

PMID:
18161542
6.
7.

Medical device regulation: an introduction for the practicing physician.

Maisel WH.

Ann Intern Med. 2004 Feb 17;140(4):296-302. Review.

PMID:
14970153
8.

The nightmare of FDA clearance/approval to market: perception or reality?

Tylenda CA.

Technol Health Care. 1996 Sep;4(3):259-67.

PMID:
8931236
9.

New orthopedic devices and the FDA.

Sheth U, Nguyen NA, Gaines S, Bhandari M, Mehlman CT, Klein G.

J Long Term Eff Med Implants. 2009;19(3):173-84.

PMID:
20939777
10.

How do regulatory agencies ensure the release of a safe medical device?

Haggar B.

Clin Perform Qual Health Care. 1999 Apr-Jun;7(2):100-3.

PMID:
10747561
11.

New FDA draft guidance on premarket submissions.

Donawa ME.

Med Device Technol. 1999 Oct;10(8):12-4.

PMID:
10724773
12.

Missing data in the regulation of medical devices.

Campbell G, Pennello G, Yue L.

J Biopharm Stat. 2011 Mar;21(2):180-95. doi: 10.1080/10543406.2011.550094. Review.

PMID:
21390995
13.
14.

FDA marketing claims, and the practitioner.

Runner S.

J Evid Based Dent Pract. 2006 Mar;6(1):19-23.

PMID:
17138391
16.

The FDA and the medical device approval process.

Guez G, Garg A.

Dent Implantol Update. 2012 May;23(5):33-7. No abstract available.

PMID:
22594003
17.

Bayesian optimal adaptive designs for delayed-response dose-finding studies.

Li W, Fu H.

J Biopharm Stat. 2011 Sep;21(5):888-901. doi: 10.1080/10543406.2011.589642.

PMID:
21830921
18.
20.

Ensuring safe and effective medical devices.

Feigal DW, Gardner SN, McClellan M.

N Engl J Med. 2003 Jan 16;348(3):191-2. No abstract available.

PMID:
12529457
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