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 *

201 related articles for article (PubMed ID: 36456539)

  • 1. Mechanistic modeling of drug products applied to the skin: A workshop summary report.
    Tsakalozou E; Alam K; Ghosh P; Spires J; Polak S; Fang L; Sammeta S; Zhao P; Arora S; Raney SG
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):575-584. PubMed ID: 36456539
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report.
    Tan ML; Chandran S; Jereb R; Alam K; Bies R; Kozak D; Walenga R; Le Merdy M; Babiskin A
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):631-638. PubMed ID: 36851886
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.
    Babiskin A; Wu F; Mousa Y; Tan ML; Tsakalozou E; Walenga RL; Yoon M; Raney SG; Polli JE; Schwendeman A; Krishnan V; Fang L; Zhao L
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):619-623. PubMed ID: 36631942
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products-a Meeting Report.
    Tsakalozou E; Fang L; Bi Y; van den Heuvel M; Ahmed T; Tsang YC; Lionberger R; Rostami-Hodjegan A; Zhao L
    AAPS J; 2024 Jan; 26(1):14. PubMed ID: 38200397
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.
    Wu F; Mousa Y; Raines K; Bode C; Tsang YC; Cristofoletti R; Zhang H; Heimbach T; Fang L; Kesisoglou F; Mitra A; Polli J; Kim MJ; Fan J; Zolnik BS; Sun D; Zhang Y; Zhao L
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):585-597. PubMed ID: 36530026
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.
    Al Shoyaib A; Riedmaier AE; Kumar A; Roy P; Parrott NJ; Fang L; Tampal N; Yang Y; Jereb R; Zhao L; Wu F
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):610-618. PubMed ID: 36597353
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products.
    Wu F; Mousa Y; Jereb R; Batchelor H; Chakraborty S; Heimbach T; Stier E; Kesisoglou F; Kollipara S; Zhang L; Zhao L
    AAPS J; 2024 Jan; 26(1):19. PubMed ID: 38267737
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.
    Pal A; Wu F; Walenga R; Tsakalozou E; Alam K; Gong Y; Zhao L; Fang L
    AAPS J; 2024 Apr; 26(3):45. PubMed ID: 38589695
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Physiologically-Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations.
    Tsakalozou E; Alam K; Babiskin A; Zhao L
    Clin Pharmacol Ther; 2022 May; 111(5):1036-1049. PubMed ID: 34231211
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop.
    Gong Y; Zhang P; Yoon M; Zhu H; Kohojkar A; Hooker AC; Ducharme MP; Gobburu J; Cellière G; Gajjar P; Li BV; Velagapudi R; Tsang YC; Schwendeman A; Polli J; Fang L; Lionberger R; Zhao L
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):624-630. PubMed ID: 36710372
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development.
    Gong Y; Barretto FX; Tsong Y; Mousa Y; Ren K; Kozak D; Shen M; Hu M; Zhao L
    AAPS J; 2024 Jan; 26(1):15. PubMed ID: 38267593
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.
    Walenga RL; Butler C; Craven BA; Longest PW; Mohamed R; Newman B; Olsson B; Hochhaus G; Li BV; Luke MC; Zhao L; Przekwas A; Lionberger R
    CPT Pharmacometrics Syst Pharmacol; 2023 May; 12(5):560-574. PubMed ID: 36330693
    [TBL] [Abstract][Full Text] [Related]  

  • 13. How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin?
    Ghosh P; Raney SG; Luke MC
    Dermatol Clin; 2022 Jul; 40(3):279-287. PubMed ID: 35750411
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Physiologically-based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1.
    Tsakalozou E; Babiskin A; Zhao L
    CPT Pharmacometrics Syst Pharmacol; 2021 May; 10(5):399-411. PubMed ID: 33547863
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary.
    Tsakalozou E; Mohamed MF; Polak S; Heimbach T
    AAPS J; 2023 Oct; 25(6):96. PubMed ID: 37783902
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products.
    Walenga RL; Babiskin AH; Bhoopathy S; Clarke JF; De Backer J; Ducharme M; Kelly M; Le Merdy M; Yoon M; Roy P
    AAPS J; 2024 Jan; 26(1):12. PubMed ID: 38177638
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model-Based Bioequivalence.
    Lee J; Gong Y; Bhoopathy S; DiLiberti CE; Hooker AC; Rostami-Hodjegan A; Schmidt S; Suarez-Sharp S; Lukacova V; Fang L; Zhao L
    Clin Pharmacol Ther; 2021 Nov; 110(5):1190-1195. PubMed ID: 33236362
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.
    Kesselheim AS; Polinski JM; Fulchino LA; Isaman DL; Gagne JJ
    Drugs; 2015 Apr; 75(6):633-50. PubMed ID: 25822610
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.
    Zhang X; Duan J; Kesisoglou F; Novakovic J; Amidon GL; Jamei M; Lukacova V; Eissing T; Tsakalozou E; Zhao L; Lionberger R
    CPT Pharmacometrics Syst Pharmacol; 2017 Aug; 6(8):492-495. PubMed ID: 28571121
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products.
    Raney SG; Ghosh P; Ramezanli T; Lehman PA; Franz TJ
    Dermatol Clin; 2022 Jul; 40(3):319-332. PubMed ID: 35750415
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 11.