207 related articles for article (PubMed ID: 28161118)
1. More Efficient Compliance with European Medicines Agency and Food and Drug Administration Regulations for Pediatric Oncology Drug Development: Problems and Solutions.
Milne CP
Clin Ther; 2017 Feb; 39(2):238-245. PubMed ID: 28161118
[TBL] [Abstract][Full Text] [Related]
2. Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.
Barry E; Walsh JA; Weinrich SL; Beaupre D; Blasi E; Arenson DR; Jacobs IA
Paediatr Drugs; 2021 Jul; 23(4):381-394. PubMed ID: 34173206
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. 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]
5. Creating a unique, multi-stakeholder Paediatric Oncology Platform to improve drug development for children and adolescents with cancer.
Vassal G; Rousseau R; Blanc P; Moreno L; Bode G; Schwoch S; Schrappe M; Skolnik J; Bergman L; Bradley-Garelik MB; Saha V; Pearson A; Zwierzina H
Eur J Cancer; 2015 Jan; 51(2):218-24. PubMed ID: 25434924
[TBL] [Abstract][Full Text] [Related]
6. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatrics Formulation Initiative: proceedings from the Second Workshop on Pediatric Formulations.
Giacoia GP; Taylor-Zapata P; Zajicek A
Clin Ther; 2012 Nov; 34(11):S1-10. PubMed ID: 23149008
[TBL] [Abstract][Full Text] [Related]
7. [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]
8. New drugs for children and adolescents with cancer: the need for novel development pathways.
Vassal G; Zwaan CM; Ashley D; Le Deley MC; Hargrave D; Blanc P; Adamson PC
Lancet Oncol; 2013 Mar; 14(3):e117-24. PubMed ID: 23434337
[TBL] [Abstract][Full Text] [Related]
9. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.
Tsukamoto K; Carroll KA; Onishi T; Matsumaru N; Brasseur D; Nakamura H
Clin Ther; 2016 Mar; 38(3):574-81. PubMed ID: 26869192
[TBL] [Abstract][Full Text] [Related]
10. Anticancer Drug Development: The Way Forward.
Connors T
Oncologist; 1996; 1(3):180-181. PubMed ID: 10387985
[TBL] [Abstract][Full Text] [Related]
11. New Drugs for Rare Diseases in Children.
Rose K
Clin Ther; 2017 Feb; 39(2):246-252. PubMed ID: 28161117
[TBL] [Abstract][Full Text] [Related]
12. Physiologically Based Pharmacokinetic Modeling in Pediatric Oncology Drug Development.
Rioux N; Waters NJ
Drug Metab Dispos; 2016 Jul; 44(7):934-43. PubMed ID: 26936973
[TBL] [Abstract][Full Text] [Related]
13. Strategies to facilitate adolescent access to medicines: Improving regulatory guidance.
Bucci-Rechtweg C; Siapkara A; An Haack Bonnet K; Corriol Rohou S; Haf Davies E; Dehlinger Kremer M; Gamalo M; Moreno C; Nelson RM; Thomas Turner R
Clin Trials; 2023 Feb; 20(1):13-21. PubMed ID: 36341541
[TBL] [Abstract][Full Text] [Related]
14. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
15. European perspectives on pediatric formulations.
Breitkreutz J
Clin Ther; 2008 Nov; 30(11):2146-54. PubMed ID: 19108802
[TBL] [Abstract][Full Text] [Related]
16. Bridging Adult Experience to Pediatrics in Oncology Drug Development.
Leong R; Zhao H; Reaman G; Liu Q; Wang Y; Stewart CF; Burckart G
J Clin Pharmacol; 2017 Oct; 57 Suppl 10():S129-S135. PubMed ID: 28921643
[TBL] [Abstract][Full Text] [Related]
17. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups.
Giacoia GP; Taylor-Zapata P; Mattison D
Clin Ther; 2008 Nov; 30(11):2097-101. PubMed ID: 19108797
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
Senderowicz AM; Pfaff O
Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
[TBL] [Abstract][Full Text] [Related]
20. Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.
Sun H; Vesely R; Nelson RM; Taminiau J; Szitanyi P; Isaac M; Klein A; Uzu S; Griebel D; Mulberg AE;
J Pediatr Gastroenterol Nutr; 2014 Jun; 58(6):684-8. PubMed ID: 24866782
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
