These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
173 related articles for article (PubMed ID: 33503308)
1. Evolving drug regulatory landscape in China: A clinical pharmacology perspective. Tang W; Huang Y; Zhou D; Huang Y; Chen Y; Ren S; Li Y; Wu S; Zhao X; Song X; Wang H; Jin Y; Yu H; Zhang L; Li Y; Boulton D; Shen K Clin Transl Sci; 2021 Jul; 14(4):1222-1230. PubMed ID: 33503308 [TBL] [Abstract][Full Text] [Related]
2. The Impact of Regulatory Reforms in China on Drug Lag: The Role of Clinical Development Strategies. Han Y; Jiang R; Li J; Wang Y; Shao R; Xie J Clin Pharmacol Ther; 2024 Jun; 115(6):1400-1407. PubMed ID: 38429944 [TBL] [Abstract][Full Text] [Related]
3. 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]
4. Ophthalmic Drug Discovery and Development: Regulatory Aspects of Patient Focused Drug Development in Ophthalmology. Rowe-Rendleman CL Pharm Res; 2019 Feb; 36(4):54. PubMed ID: 30790065 [TBL] [Abstract][Full Text] [Related]
5. [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]
6. 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]
7. Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape. Benda N; Brandt A J Biopharm Stat; 2018; 28(1):3-9. PubMed ID: 29065277 [TBL] [Abstract][Full Text] [Related]
8. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States. Salcher-Konrad M; Naci H; Davis C Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339 [TBL] [Abstract][Full Text] [Related]
9. Impact of Federal Regulatory Changes on Clinical Pharmacology and Drug Development: the Common Rule and the 21st Century Cures Act. Burris JF; Puglisi JT J Clin Pharmacol; 2018 Mar; 58(3):281-285. PubMed ID: 28981164 [TBL] [Abstract][Full Text] [Related]
10. 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]
11. The changing scene of the regulation of medicines in the UK. Paper from The Use of Medicines: Regulation & Clinical Pharmacology in the 21st Century Symposium - December 2003. Breckenridge A Br J Clin Pharmacol; 2004 Dec; 58(6):571-4. PubMed ID: 15563354 [TBL] [Abstract][Full Text] [Related]
12. Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends. Liu Q; Ahadpour M; Rocca M; Huang SM AAPS J; 2021 Apr; 23(3):54. PubMed ID: 33846878 [TBL] [Abstract][Full Text] [Related]
13. Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other? Teixeira T; Kweder SL; Saint-Raymond A Clin Pharmacol Ther; 2020 Mar; 107(3):507-513. PubMed ID: 31449664 [TBL] [Abstract][Full Text] [Related]
14. Clinical trial development for biosimilars. Alten R; Cronstein BN Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S2-8. PubMed ID: 26058550 [TBL] [Abstract][Full Text] [Related]
16. Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes? Richardson E; Daniel G; Joy DR; Kweder SL; Maloney DM; Raggio MJ; Jarow JP Ther Innov Regul Sci; 2018 Nov; 52(6):793-798. PubMed ID: 29714587 [TBL] [Abstract][Full Text] [Related]
17. The drug lag issue: a 20-year review of China. Li X; Yang Y Invest New Drugs; 2021 Oct; 39(5):1389-1398. PubMed ID: 33928468 [TBL] [Abstract][Full Text] [Related]
18. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Huang SM; Temple R; Throckmorton DC; Lesko LJ Clin Pharmacol Ther; 2007 Feb; 81(2):298-304. PubMed ID: 17259955 [TBL] [Abstract][Full Text] [Related]
19. 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]
20. Promoting, improving and accelerating the drug development and approval processes. Graul AI Drug News Perspect; 2008; 21(1):36-43. PubMed ID: 18301808 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]