Detalhe da pesquisa
1.
Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.
J Urol
; 203(1): 115-119, 2020 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-31502940
2.
Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.
Clin Trials
; 14(3): 225-233, 2017 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-28345368
3.
Variability of semen parameters with time in placebo treated men.
J Urol
; 189(5): 1825-9, 2013 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-23159587
4.
Use of biomarkers to assess tissue specific androgen adequacy: defining male hypogonadism.
J Urol
; 189(2): 633-7, 2013 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-23260553
5.
Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data.
JAMA
; 318(8): 703-704, 2017 Aug 22.
Artigo
em Inglês
| MEDLINE | ID: mdl-28715550
6.
Benign prostate glands at the bladder neck margin in robotic vs open radical prostatectomy.
BJU Int
; 105(10): 1446-9, 2010 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-20346031
7.
Noninvasive laser vasectomy: preliminary ex vivo tissue studies.
Lasers Surg Med
; 41(3): 203-7, 2009 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-19291751
8.
Personalized reproductive medicine: regulatory considerations.
Fertil Steril
; 109(6): 964-967, 2018 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-29935654
9.
Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?
Ther Innov Regul Sci
; 52(6): 793-798, 2018 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-29714587
10.
Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
Clin Pharmacol Ther
; 104(2): 282-289, 2018 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-29473145
11.
Diagnostic approach to the infertile male patient.
Endocrinol Metab Clin North Am
; 36(2): 297-311, 2007 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-17543720
12.
Impact of Expanded Access on FDA Regulatory Action and Product Labeling.
Ther Innov Regul Sci
; 51(6): 787-789, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-30079277
13.
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient Safety.
Ther Innov Regul Sci
; 51(2): 246-249, 2017 Mar 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28553566
14.
Overview of FDA's Expanded Access Program for Investigational Drugs.
Ther Innov Regul Sci
; 51(2): 177-179, 2017 Mar 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28553565
15.
Precision medicine and the changing role of regulatory agencies.
Nat Rev Drug Discov
; 15(12): 805-806, 2016 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-27739512
16.
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.
Ther Innov Regul Sci
; 50(6): 705-709, 2016 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-27917324
17.
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
Clin Cancer Res
; 22(9): 2111-3, 2016 05 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-26783289
18.
Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop.
Urology
; 88: 8-13, 2016 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-26621480
19.
Summary and Recommendations from the National Cancer Institute's Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer.
Bladder Cancer
; 2(2): 165-202, 2016 Apr 27.
Artigo
em Inglês
| MEDLINE | ID: mdl-27376138
20.
Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression.
J Clin Endocrinol Metab
; 90(5): 2595-602, 2005 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-15713727