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.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

180 related articles for article (PubMed ID: 31515957)

  • 1. The Importance of the Human Mass Balance Study in Regulatory Submissions.
    Coppola P; Andersson A; Cole S
    CPT Pharmacometrics Syst Pharmacol; 2019 Nov; 8(11):792-804. PubMed ID: 31515957
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Regulatory perspective of bioanalysis from a clinical pharmacology reviewer standpoint: do you see what I see?
    Yu C; Bashaw E
    Bioanalysis; 2014 Feb; 6(4):505-10. PubMed ID: 24568353
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues.
    Huang SM; Lesko LJ; Williams RL
    J Clin Pharmacol; 1999 Oct; 39(10):1006-14. PubMed ID: 10516934
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs.
    Kaspera R; Shitara Y
    AAPS J; 2024 Jun; 26(4):71. PubMed ID: 38886275
    [TBL] [Abstract][Full Text] [Related]  

  • 5. What is the objective of the mass balance study? A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs.
    Roffey SJ; Obach RS; Gedge JI; Smith DA
    Drug Metab Rev; 2007; 39(1):17-43. PubMed ID: 17364879
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Preclinical pharmacokinetics: an approach towards safer and efficacious drugs.
    Singh SS
    Curr Drug Metab; 2006 Feb; 7(2):165-82. PubMed ID: 16472106
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.
    Crider K; Williams J; Qi YP; Gutman J; Yeung L; Mai C; Finkelstain J; Mehta S; Pons-Duran C; Menéndez C; Moraleda C; Rogers L; Daniels K; Green P
    Cochrane Database Syst Rev; 2022 Feb; 2(2022):. PubMed ID: 36321557
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Human radiolabeled mass balance studies: objectives, utilities and limitations.
    Penner N; Klunk LJ; Prakash C
    Biopharm Drug Dispos; 2009 May; 30(4):185-203. PubMed ID: 19544285
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Pharmacology and toxicology of novel drug delivery systems. Regulatory issues.
    Weissinger J
    Drug Saf; 1990; 5 Suppl 1():107-13. PubMed ID: 2182053
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology.
    Zhang X; Yang Y; Grimstein M; Fan J; Grillo JA; Huang SM; Zhu H; Wang Y
    J Clin Pharmacol; 2020 Oct; 60 Suppl 1():S160-S178. PubMed ID: 33205429
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The use of concentration measurements of parent drug and metabolites during clinical trials.
    Shaw LM; Bonner HS; Fields L; Lieberman R
    Ther Drug Monit; 1993 Dec; 15(6):483-7. PubMed ID: 8122281
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A regulatory viewpoint on transporter-based drug interactions.
    Zhang L; Zhang YD; Strong JM; Reynolds KS; Huang SM
    Xenobiotica; 2008 Jul; 38(7-8):709-24. PubMed ID: 18668428
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions.
    Zhao P; Rowland M; Huang SM
    Clin Pharmacol Ther; 2012 Jul; 92(1):17-20. PubMed ID: 22713733
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The integration of pharmacokinetics and pharmacodynamics: understanding dose-response.
    Abdel-Rahman SM; Kauffman RE
    Annu Rev Pharmacol Toxicol; 2004; 44():111-36. PubMed ID: 14744241
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [Role of pharmacokinetic-pharmacodynamic relationships in drug development].
    Bellissant E; Courcier-Duplantier S; Blin O;
    Therapie; 2002; 57(4):347-57. PubMed ID: 12422555
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Metabolites and bioequivalence: past and present.
    Jackson AJ; Robbie G; Marroum P
    Clin Pharmacokinet; 2004; 43(10):655-72. PubMed ID: 15244496
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Physiological-based pharmacokinetic modeling trends in pharmaceutical drug development over the last 20-years; in-depth analysis of applications, organizations, and platforms.
    El-Khateeb E; Burkhill S; Murby S; Amirat H; Rostami-Hodjegan A; Ahmad A
    Biopharm Drug Dispos; 2021 Apr; 42(4):107-117. PubMed ID: 33325034
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Optimal design of pharmacokinetic studies.
    Aarons L; Ogungbenro K
    Basic Clin Pharmacol Toxicol; 2010 Mar; 106(3):250-5. PubMed ID: 20102362
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Impact of physiologically based pharmacokinetic modeling and simulation in drug development.
    Shardlow CE; Generaux GT; Patel AH; Tai G; Tran T; Bloomer JC
    Drug Metab Dispos; 2013 Dec; 41(12):1994-2003. PubMed ID: 24009310
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Considerations for metabolite pharmacokinetic data in bioavailability/bioequivalence assessments. Overview of the recent trends.
    Srinivas NR
    Arzneimittelforschung; 2009; 59(4):155-65. PubMed ID: 19517891
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.