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 *

235 related articles for article (PubMed ID: 32589767)

  • 1. Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities.
    Al-Huniti N; Feng Y; Yu JJ; Lu Z; Nagase M; Zhou D; Sheng J
    CPT Pharmacometrics Syst Pharmacol; 2020 Aug; 9(8):419-427. PubMed ID: 32589767
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Opportunities and challenges for applying model-informed drug development approaches to gene therapies.
    Belov A; Schultz K; Forshee R; Tegenge MA
    CPT Pharmacometrics Syst Pharmacol; 2021 Apr; 10(4):286-290. PubMed ID: 33608998
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Perspective on model-informed drug development.
    Lesko LJ
    CPT Pharmacometrics Syst Pharmacol; 2021 Oct; 10(10):1127-1129. PubMed ID: 34404115
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.
    Galluppi GR; Ahamadi M; Bhattacharya S; Budha N; Gheyas F; Li CC; Chen Y; Dosne AG; Kristensen NR; Magee M; Samtani MN; Sinha V; Taskar K; Upreti VV; Yang J; Cook J
    Clin Pharmacol Ther; 2024 Aug; 116(2):282-288. PubMed ID: 38519861
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.
    Madabushi R; Seo P; Zhao L; Tegenge M; Zhu H
    Pharm Res; 2022 Aug; 39(8):1669-1680. PubMed ID: 35552984
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Model-Informed Drug Development: Current US Regulatory Practice and Future Considerations.
    Wang Y; Zhu H; Madabushi R; Liu Q; Huang SM; Zineh I
    Clin Pharmacol Ther; 2019 Apr; 105(4):899-911. PubMed ID: 30653670
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.
    Xiong Y; Fan J; Kitabi E; Zhang X; Bi Y; Grimstein M; Yang Y; Earp JC; Zheng N; Liu J; Wang Y; Zhu H
    Clin Pharmacol Ther; 2022 Mar; 111(3):572-578. PubMed ID: 34807992
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019-2023) by US FDA, best practices and recommendations.
    Mitra A; Lee JB; Steinbach D; Hazra A; Krishna R
    J Pharmacokinet Pharmacodyn; 2023 Dec; 50(6):475-493. PubMed ID: 37925369
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Progress and Opportunities to Advance Clinical Cancer Therapeutics Using Tumor Dynamic Models.
    Bruno R; Bottino D; de Alwis DP; Fojo AT; Guedj J; Liu C; Swanson KR; Zheng J; Zheng Y; Jin JY
    Clin Cancer Res; 2020 Apr; 26(8):1787-1795. PubMed ID: 31871299
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Model-informed drug development in pediatric, pregnancy and geriatric drug development: States of the art and future.
    Wu YE; Zheng YY; Li QY; Yao BF; Cao J; Liu HX; Hao GX; van den Anker J; Zheng Y; Zhao W
    Adv Drug Deliv Rev; 2024 Aug; 211():115364. PubMed ID: 38936664
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Model-Informed Drug Development for Anti-Infectives: State of the Art and Future.
    Rayner CR; Smith PF; Andes D; Andrews K; Derendorf H; Friberg LE; Hanna D; Lepak A; Mills E; Polasek TM; Roberts JA; Schuck V; Shelton MJ; Wesche D; Rowland-Yeo K
    Clin Pharmacol Ther; 2021 Apr; 109(4):867-891. PubMed ID: 33555032
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists.
    Barrett JS; Romero K; Rayner C; Gastonguay M; Pillai GC; Tannenbaum S; Kern S; Selich M; Francisco D
    Clin Pharmacol Ther; 2024 Aug; 116(2):289-294. PubMed ID: 39012325
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Commentary on Fit-For-Purpose Models for Regulatory Applications.
    Wang Y; Huang SM
    J Pharm Sci; 2019 Jan; 108(1):18-20. PubMed ID: 30244011
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Pharmacometrics and systems pharmacology for metabolic bone diseases.
    Riggs MM; Cremers S
    Br J Clin Pharmacol; 2019 Jun; 85(6):1136-1146. PubMed ID: 30690761
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology.
    Jørgensen JT; Hersom M
    Clin Pharmacol Ther; 2018 Jun; 103(6):999-1008. PubMed ID: 29197081
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Model-Informed Drug Development in Pediatric Dose Selection.
    Bi Y; Liu J; Li F; Yu J; Bhattaram A; Bewernitz M; Li RJ; Ahn J; Earp J; Ma L; Zhuang L; Yang Y; Zhang X; Zhu H; Wang Y
    J Clin Pharmacol; 2021 Jun; 61 Suppl 1():S60-S69. PubMed ID: 34185906
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Consideration of a Credibility Assessment Framework in Model-Informed Drug Development: Potential Application to Physiologically-Based Pharmacokinetic Modeling and Simulation.
    Kuemmel C; Yang Y; Zhang X; Florian J; Zhu H; Tegenge M; Huang SM; Wang Y; Morrison T; Zineh I
    CPT Pharmacometrics Syst Pharmacol; 2020 Jan; 9(1):21-28. PubMed ID: 31652029
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies.
    Zhou L; Higashimori M; Shen K; Zhang Z; Sheng J; Xu H; Horiuchi M; Ichikawa K; Al-Huniti N; Zhou D
    Clin Pharmacol Ther; 2019 Jun; 105(6):1303-1320. PubMed ID: 30802932
    [No Abstract]   [Full Text] [Related]  

  • 19. Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs.
    Rahman A; Shah M; Shord SS
    Clin Pharmacol Ther; 2024 Sep; 116(3):577-591. PubMed ID: 39072758
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Impact of the biomarker enrichment strategy in drug development.
    Lara Gongora AB; Carvalho Oliveira LJ; Jardim DL
    Expert Rev Mol Diagn; 2020 Jun; 20(6):611-618. PubMed ID: 31903795
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 12.