141 related articles for article (PubMed ID: 19068566)
1. Regulatory inspection of clinical trials in Nigeria.
Keri HJ
Nig Q J Hosp Med; 2008; 18(2):120-2. PubMed ID: 19068566
[No Abstract] [Full Text] [Related]
2. They are from the government and they really are here to help you.
Woosley RL
J Clin Pharmacol; 2008 Feb; 48(2):142-3. PubMed ID: 18199889
[No Abstract] [Full Text] [Related]
3. Communicating with the FDA: the "third rail" of a new model for drug development.
Stanski DR; Orloff JJ
J Clin Pharmacol; 2008 Feb; 48(2):144-5. PubMed ID: 18199890
[No Abstract] [Full Text] [Related]
4. [The stakes of pre- and post-market authorization development and clinical assessment].
Schwebig A
Presse Med; 2012 May; 41 Suppl 1():S6-8. PubMed ID: 22483770
[No Abstract] [Full Text] [Related]
5. European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287.
Flavell DJ; Flavell SU; Sullivan R
Lancet; 2003 Oct; 362(9393):1415. PubMed ID: 14585646
[No Abstract] [Full Text] [Related]
6. Cell and tissue therapy regulation: worldwide status and harmonization.
Kellathur SN; Lou HX
Biologicals; 2012 May; 40(3):222-4. PubMed ID: 22374355
[TBL] [Abstract][Full Text] [Related]
7. [The inspection by the Danish Medical Products Agency of drug clinical trials].
Jacobsen E; Stilbo I
Ugeskr Laeger; 2003 Apr; 165(16):1656-8. PubMed ID: 12756822
[TBL] [Abstract][Full Text] [Related]
8. Rapid drug access and scientific rigour: a delicate balance.
The Lancet Neurology
Lancet Neurol; 2021 Jan; 20(1):1. PubMed ID: 33340471
[No Abstract] [Full Text] [Related]
9. The gap between clinical trials and clinical practice: the use of pragmatic clinical trials to inform regulatory decision making.
Brass EP
Clin Pharmacol Ther; 2010 Mar; 87(3):351-5. PubMed ID: 20010554
[No Abstract] [Full Text] [Related]
10. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
Wang Y; Bhattaram AV; Jadhav PR; Lesko LJ; Madabushi R; Powell JR; Qiu W; Sun H; Yim DS; Zheng JJ; Gobburu JV
J Clin Pharmacol; 2008 Feb; 48(2):146-56. PubMed ID: 18199891
[TBL] [Abstract][Full Text] [Related]
11. The relevance of good research reporting.
The Lancet Neurology
Lancet Neurol; 2016 Oct; 15(11):1103. PubMed ID: 27647632
[No Abstract] [Full Text] [Related]
12. The lessons of failure: clinical flops are helping researchers define the keys to successful cancer drug trials.
Nelson B
Cancer Cytopathol; 2012 Dec; 120(6):359-60. PubMed ID: 23242934
[No Abstract] [Full Text] [Related]
13. Moment of reckoning.
Wadman M
Nature; 2007 Apr; 446(7138):844-5. PubMed ID: 17443154
[No Abstract] [Full Text] [Related]
14. Relocating abroad. FDA sends staff overseas to help monitor imports.
Lee J
Mod Healthc; 2011 Oct; 41(43):32. PubMed ID: 22111150
[No Abstract] [Full Text] [Related]
15. Addressing Conflict of Interest and Bias in Research, Education and Clinical Practice.
Lau DC
Can J Diabetes; 2015 Aug; 39(4):247-9. PubMed ID: 26116472
[No Abstract] [Full Text] [Related]
16. Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.
Corrigan-Curay J; Sacks L; Woodcock J
JAMA; 2018 Sep; 320(9):867-868. PubMed ID: 30105359
[No Abstract] [Full Text] [Related]
17. Harmonization in the regulation of pharmaceutical research and human rights: the need to think globally.
Dominguez-Urban I
Cornell Int Law J; 1997; 30(2):245-86. PubMed ID: 12194190
[No Abstract] [Full Text] [Related]
18. Pediatric requirements in Europe stymie help for hemophilia.
Peyvandi F; Rosendaal FR; O'Mahony B; Mannuccio Mannucci P
Nat Med; 2014 Feb; 20(2):117. PubMed ID: 24504399
[No Abstract] [Full Text] [Related]
19. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).
Jones DR; McBlane JW; McNaughton G; Rajakumaraswamy N; Wydenbach K
Br J Clin Pharmacol; 2013 Aug; 76(2):203-9. PubMed ID: 23216470
[TBL] [Abstract][Full Text] [Related]
20. Clinical trials in status epilepticus-The clinical perspective.
Kälviäinen R
Epilepsia; 2009 Dec; 50 Suppl 12():75-6. PubMed ID: 19941534
[No Abstract] [Full Text] [Related]
[Next] [New Search]