337 related articles for article (PubMed ID: 12951576)
21. Food and Drug Administration approval process for ophthalmic drugs in the US.
Lloyd R; Harris J; Wadhwa S; Chambers W
Curr Opin Ophthalmol; 2008 May; 19(3):190-4. PubMed ID: 18408492
[TBL] [Abstract][Full Text] [Related]
22. Assessing prescription medications for priority regulatory review.
Rawson NS
Regul Toxicol Pharmacol; 2005 Jun; 42(1):70-6. PubMed ID: 15896445
[TBL] [Abstract][Full Text] [Related]
23. Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe.
Boon WP; Moors EH; Meijer A; Schellekens H
Clin Pharmacol Ther; 2010 Dec; 88(6):848-53. PubMed ID: 20962774
[TBL] [Abstract][Full Text] [Related]
24. Biopharmaceutical benchmarks--2003.
Walsh G
Nat Biotechnol; 2003 Aug; 21(8):865-70. PubMed ID: 12894198
[No Abstract] [Full Text] [Related]
25. 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]
26. Original research: Intravenous ribavirin--review of the FDA's Emergency Investigational New Drug Database (1997-2008) and literature review.
Riner A; Chan-Tack KM; Murray JS
Postgrad Med; 2009 May; 121(3):139-46. PubMed ID: 19491552
[TBL] [Abstract][Full Text] [Related]
27. Obtaining drugs from foreign markets.
Shirk MB; Hale KN
Am J Hosp Pharm; 1992 Nov; 49(11):2731-9. PubMed ID: 1471638
[TBL] [Abstract][Full Text] [Related]
28. Approval of new biopharmaceuticals 1999-2006: comparison of the US, EU and Japan situations.
Tsuji K; Tsutani K
Eur J Pharm Biopharm; 2008 Mar; 68(3):496-502. PubMed ID: 17884403
[TBL] [Abstract][Full Text] [Related]
29. 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]
30. Expanded access to investigational drugs for treatment use. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2009 Aug; 74(155):40900-45. PubMed ID: 19691173
[TBL] [Abstract][Full Text] [Related]
31. Methuselah's medicine: pharmaceutical innovation and mortality in the United States, 1960-2000.
Schnittker J; Karandinos G
Soc Sci Med; 2010 Apr; 70(7):961-8. PubMed ID: 20100632
[TBL] [Abstract][Full Text] [Related]
32. Characteristics of and trends in the late-stage biopharmaceutical pipeline.
Nagle PC; Nicita CA; Gerdes LA; Schmeichel CJ
Am J Manag Care; 2008 Apr; 14(4):226-9. PubMed ID: 18402515
[TBL] [Abstract][Full Text] [Related]
33. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
Reeve LM
Regul Toxicol Pharmacol; 2009 Nov; 55(2):181-7. PubMed ID: 19589365
[TBL] [Abstract][Full Text] [Related]
34. New drugs in India over the past 15 years: analysis of trends.
Ghosh A; Hazra A; Mandal SC
Natl Med J India; 2004; 17(1):10-6. PubMed ID: 15115225
[TBL] [Abstract][Full Text] [Related]
35. New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2002 May; 67(105):37988-98. PubMed ID: 12049094
[TBL] [Abstract][Full Text] [Related]
36. Trends in risks associated with new drug development: success rates for investigational drugs.
DiMasi JA; Feldman L; Seckler A; Wilson A
Clin Pharmacol Ther; 2010 Mar; 87(3):272-7. PubMed ID: 20130567
[TBL] [Abstract][Full Text] [Related]
37. Tricky FDA debate: should a risky drug be approved again?
Mathews AW; Westphal SP
Wall St J (East Ed); 2006 Feb; ():B1, B4. PubMed ID: 16528879
[No Abstract] [Full Text] [Related]
38. [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].
Kock M; Thomsen MK
Ugeskr Laeger; 2003 Apr; 165(16):1649-52. PubMed ID: 12756820
[TBL] [Abstract][Full Text] [Related]
39. Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.
Kaitin KI; DiMasi JA
Clin Pharmacol Ther; 2011 Feb; 89(2):183-8. PubMed ID: 21191382
[TBL] [Abstract][Full Text] [Related]
40. Obstacles and opportunities in new drug development.
Kaitin KI
Clin Pharmacol Ther; 2008 Feb; 83(2):210-2. PubMed ID: 18202685
[No Abstract] [Full Text] [Related]
[Previous] [Next] [New Search]