132 related articles for article (PubMed ID: 32857419)
41. Comparison of estimated glomerular filtration rate with estimated creatinine clearance in the dosing of drugs requiring adjustments in elderly patients with declining renal function.
Spruill WJ; Wade WE; Cobb HH
Am J Geriatr Pharmacother; 2008 Aug; 6(3):153-60. PubMed ID: 18775390
[TBL] [Abstract][Full Text] [Related]
42. Compatibility of immunogenicity guidance by the EMA and the US FDA.
Kurki P
Bioanalysis; 2019 Sep; 11(17):1619-1629. PubMed ID: 30672313
[TBL] [Abstract][Full Text] [Related]
43. The role of DMPK science in improving pharmaceutical research and development efficiency.
Mak KK; Epemolu O; Pichika MR
Drug Discov Today; 2022 Mar; 27(3):705-729. PubMed ID: 34774767
[TBL] [Abstract][Full Text] [Related]
44. EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age.
Thor S; Vetter T; Marcal A; Kweder S
Ther Innov Regul Sci; 2023 Jul; 57(4):656-661. PubMed ID: 36871110
[TBL] [Abstract][Full Text] [Related]
45. Comparison of Drug Approvals in Europe Versus the United States: An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA.
Makuch RW; Shi R
Ther Innov Regul Sci; 2014 May; 48(3):362-366. PubMed ID: 30235531
[TBL] [Abstract][Full Text] [Related]
46. Strength of evidence for labeled dosing recommendations in renal impairment.
Gagne JJ; Khan NF; Raj TS; Patel LR; Choudhry NK
Clin Trials; 2017 Apr; 14(2):219-221. PubMed ID: 27780884
[TBL] [Abstract][Full Text] [Related]
47. Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice.
Trotta F; Leufkens HG; Schellens JH; Laing R; Tafuri G
J Clin Oncol; 2011 Jun; 29(16):2266-72. PubMed ID: 21537038
[TBL] [Abstract][Full Text] [Related]
48. Towards Further Verification of Physiologically-Based Kidney Models: Predictability of the Effects of Urine-Flow and Urine-pH on Renal Clearance.
Matsuzaki T; Scotcher D; Darwich AS; Galetin A; Rostami-Hodjegan A
J Pharmacol Exp Ther; 2019 Feb; 368(2):157-168. PubMed ID: 30413628
[TBL] [Abstract][Full Text] [Related]
49. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.
Cardot JM; Garcia Arieta A; Paixao P; Tasevska I; Davit B
AAPS J; 2016 Jul; 18(4):1039-46. PubMed ID: 27116020
[TBL] [Abstract][Full Text] [Related]
50. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
Yu LX; Baker J; Berlam SC; Boam A; Brandreth EJ; Buhse L; Cosgrove T; Doleski D; Ensor L; Famulare J; Ganapathy M; Grampp G; Hussong D; Iser R; Johnston G; Kesisoglou F; Khan M; Kozlowski S; Lacana E; Lee SL; Miller S; Miksinski SP; Moore CM; Mullin T; Raju GK; Raw A; Rosencrance S; Rosolowsky M; Stinavage P; Thomas H; Wesdyk R; Windisch J; Vaithiyalingam S
AAPS J; 2015 Jul; 17(4):1011-8. PubMed ID: 25840884
[TBL] [Abstract][Full Text] [Related]
51. Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.
Collignon O; Koenig F; Koch A; Hemmings RJ; Pétavy F; Saint-Raymond A; Papaluca-Amati M; Posch M
Trials; 2018 Nov; 19(1):642. PubMed ID: 30454061
[TBL] [Abstract][Full Text] [Related]
52. The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies.
Sharma V; Deore VD; Deore SV; Martin IG
Ther Innov Regul Sci; 2020 Jul; 54(4):770-774. PubMed ID: 32557295
[TBL] [Abstract][Full Text] [Related]
53. Model-Based Approach for Designing an Efficient Bioequivalence Study for Highly Variable Drugs.
Song E; Lee W; Kim BH
Pharmaceuticals (Basel); 2021 Oct; 14(11):. PubMed ID: 34832883
[TBL] [Abstract][Full Text] [Related]
54. A systematic review on disease-drug-drug interactions with immunomodulating drugs: A critical appraisal of risk assessment and drug labelling.
de Jong LM; Klomp SD; Treijtel N; Rissmann R; Swen JJ; Manson ML
Br J Clin Pharmacol; 2022 Oct; 88(10):4387-4402. PubMed ID: 35484780
[TBL] [Abstract][Full Text] [Related]
55. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014.
Hatswell AJ; Baio G; Berlin JA; Irs A; Freemantle N
BMJ Open; 2016 Jun; 6(6):e011666. PubMed ID: 27363818
[TBL] [Abstract][Full Text] [Related]
56. Urinary excretion: does it accurately reflect relative differences in bioavailability/systemic exposure when renal clearance is nonlinear?
Thompson GA; Toothaker RD
Pharm Res; 2004 May; 21(5):781-4. PubMed ID: 15180334
[TBL] [Abstract][Full Text] [Related]
57. Quantitative Assessment of the Effect of Chronic Kidney Disease on the Nonrenal Clearance of 10 Drugs After Intravenous Administration.
Hinderling PH; Yu Y
Clin Pharmacol Drug Dev; 2019 Feb; 8(2):138-151. PubMed ID: 30589517
[TBL] [Abstract][Full Text] [Related]
58. Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission.
Cardot JM; Garcia-Arieta A; Paixao P; Tasevska I; Davit B
Eur J Pharm Sci; 2018 Jan; 111():399-408. PubMed ID: 29032306
[TBL] [Abstract][Full Text] [Related]
59. 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]
60. Prediction of the Effects of Renal Impairment on Clearance for Organic Cation Drugs that Undergo Renal Secretion: A Simulation-Based Study.
Follman KE; Morris ME
Drug Metab Dispos; 2018 May; 46(5):758-769. PubMed ID: 29490902
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
