2263 related articles for article (PubMed ID: 25175054)
1. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
Pflieger M; Bertram D
Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
[TBL] [Abstract][Full Text] [Related]
2. Lack of compliance of European Public Assessment Reports to guidelines for paediatric drug development before the introduction of paediatric investigation plans.
Piana C; Kliphuis E; Della Pasqua O
Clin Trials; 2013 Apr; 10(2):269-79. PubMed ID: 23335676
[TBL] [Abstract][Full Text] [Related]
3. The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements.
Cocchetto DM
Qual Assur; 1995 Dec; 4(4):240-6. PubMed ID: 8890349
[TBL] [Abstract][Full Text] [Related]
4. European Union pediatric legislation jeopardizes worldwide, timely future advances in the care of children with cancer.
Rose K
Clin Ther; 2014 Feb; 36(2):163-77. PubMed ID: 24529288
[TBL] [Abstract][Full Text] [Related]
5. Statistical concepts in the planning and evaluation of drug safety from clinical trials in drug development: issues of international harmonization.
O'Neill RT
Stat Med; 1995 May 15-30; 14(9-10):117-27. PubMed ID: 7569506
[TBL] [Abstract][Full Text] [Related]
6. [Our policy and future tasks related to ICH in anti-cancer drug development--a discussion from the viewpoint of an enterprise].
Ekimoto H
Gan To Kagaku Ryoho; 1997 Jan; 24(2):229-37. PubMed ID: 9030236
[TBL] [Abstract][Full Text] [Related]
7. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2000 Dec; 65(242):78493-4. PubMed ID: 12362934
[TBL] [Abstract][Full Text] [Related]
8. Industry perspectives on ICH guidelines.
Rockhold FW
Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
[TBL] [Abstract][Full Text] [Related]
9. Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.
Chin WW; Joos A
Eur J Pediatr; 2016 Dec; 175(12):1881-1891. PubMed ID: 27646479
[TBL] [Abstract][Full Text] [Related]
10. European perspectives on pediatric formulations.
Breitkreutz J
Clin Ther; 2008 Nov; 30(11):2146-54. PubMed ID: 19108802
[TBL] [Abstract][Full Text] [Related]
11. Regulatory advice and drug development--a case study in negotiating with regulators.
Seldrup J
Stat Med; 2011 Jun; 30(13):1628-35. PubMed ID: 21365671
[TBL] [Abstract][Full Text] [Related]
12. Delays in new drug applications in Japan and industrial R&D strategies.
Hirai Y; Kinoshita H; Kusama M; Yasuda K; Sugiyama Y; Ono S
Clin Pharmacol Ther; 2010 Feb; 87(2):212-8. PubMed ID: 19940847
[TBL] [Abstract][Full Text] [Related]
13. International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2001 Oct; 66(200):52634-7. PubMed ID: 12358037
[TBL] [Abstract][Full Text] [Related]
14. The economics of pediatric formulation development for off-patent drugs.
Milne CP; Bruss JB
Clin Ther; 2008 Nov; 30(11):2133-45. PubMed ID: 19108801
[TBL] [Abstract][Full Text] [Related]
15. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2015 Jan; 80(17):4282-3. PubMed ID: 25730921
[TBL] [Abstract][Full Text] [Related]
16. International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2011 Aug; 76(163):52667-8. PubMed ID: 21894658
[TBL] [Abstract][Full Text] [Related]
17. Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan.
Rokuda M; Matsumaru N; Tsukamoto K
Clin Ther; 2018 Feb; 40(2):284-295. PubMed ID: 29361305
[TBL] [Abstract][Full Text] [Related]
18. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.
Molzon JA; Giaquinto A; Lindstrom L; Tominaga T; Ward M; Doerr P; Hunt L; Rago L
Clin Pharmacol Ther; 2011 Apr; 89(4):503-12. PubMed ID: 21326288
[TBL] [Abstract][Full Text] [Related]
19. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2008 Aug; 73(151):45462-3. PubMed ID: 18949880
[TBL] [Abstract][Full Text] [Related]
20. Stability testing requirements for vaccines--draft guidelines of the International Conference on Harmonization.
Haase M
Dev Biol Stand; 1996; 87():309-18. PubMed ID: 8854031
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
