BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

157 related articles for article (PubMed ID: 38043684)

  • 1. Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives.
    Kollipara S; Martins FS; Sanghavi M; Santos GML; Saini A; Ahmed T
    J Pharm Sci; 2024 Feb; 113(2):345-358. PubMed ID: 38043684
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs.
    Wu D; Sanghavi M; Kollipara S; Ahmed T; Saini AK; Heimbach T
    Pharm Res; 2023 Feb; 40(2):337-357. PubMed ID: 35840856
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
    Mitra A; Suarez-Sharp S; Pepin XJH; Flanagan T; Zhao Y; Kotzagiorgis E; Parrott N; Sharan S; Tistaert C; Heimbach T; Zolnik B; Sjögren E; Wu F; Anand O; Kakar S; Li M; Veerasingham S; Kijima S; Lima Santos GM; Ning B; Raines K; Rullo G; Mandula H; Delvadia P; Dressman J; Dickinson PA; Babiskin A
    J Pharm Sci; 2021 Feb; 110(2):594-609. PubMed ID: 33152375
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM).
    Jereb R; Kristl A; Mitra A
    Eur J Pharm Sci; 2020 Dec; 155():105554. PubMed ID: 32946959
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space.
    Bhattiprolu AK; Kollipara S; Ahmed T; Boddu R; Chachad S
    J Pharm Sci; 2022 Dec; 111(12):3397-3410. PubMed ID: 36096285
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space.
    Miranda Dos Santos E; Ferraz HG; Issa MG; Duque MD
    J Pharm Sci; 2023 Dec; 112(12):3131-3140. PubMed ID: 37473918
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Integration of artificial neural network and physiologically based biopharmaceutic models in the development of sustained-release formulations.
    Severino Martins F; Borges L; Oliveira do Couto R; Schaller S; de Freitas O
    Biopharm Drug Dispos; 2023 Aug; 44(4):335-343. PubMed ID: 37649136
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective.
    Kollipara S; Bhattiprolu AK; Boddu R; Ahmed T; Chachad S
    AAPS PharmSciTech; 2023 Feb; 24(2):59. PubMed ID: 36759492
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Towards Virtual Bioequivalence Studies for Oral Dosage Forms Containing Poorly Water-Soluble Drugs: A Physiologically Based Biopharmaceutics Modeling (PBBM) Approach.
    Kambayashi A; Dressman JB
    J Pharm Sci; 2022 Jan; 111(1):135-145. PubMed ID: 34390740
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.
    Anand O; Pepin XJH; Kolhatkar V; Seo P
    Pharm Res; 2022 Aug; 39(8):1681-1700. PubMed ID: 35585448
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies.
    Heimbach T; Kesisoglou F; Novakovic J; Tistaert C; Mueller-Zsigmondy M; Kollipara S; Ahmed T; Mitra A; Suarez-Sharp S
    J Pharm Sci; 2021 Dec; 110(12):3896-3906. PubMed ID: 34551349
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.
    Wang M; Heimbach T; Zhu W; Wu D; Reuter KG; Kesisoglou F
    AAPS J; 2024 Jun; 26(4):69. PubMed ID: 38862807
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions.
    Boddu R; Kollipara S; Vijaywargi G; Ahmed T
    Xenobiotica; 2023 Apr; 53(4):260-278. PubMed ID: 37471259
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.
    Ahmed T; Kollipara S; Boddu R; Bhattiprolu AK
    AAPS J; 2023 Jul; 25(5):77. PubMed ID: 37498474
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption.
    Laisney M; Heimbach T; Mueller-Zsigmondy M; Blumenstein L; Costa R; Ji Y
    J Pharm Sci; 2022 Jan; 111(1):274-284. PubMed ID: 34678270
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.
    Parrott N; Suarez-Sharp S; Kesisoglou F; Pathak SM; Good D; Wagner C; Dallmann A; Mullin J; Patel N; Riedmaier AE; Mitra A; Raines K; Butler J; Kakhi M; Li M; Zhao Y; Tsakalozou E; Flanagan T; Dressman J; Pepin X
    J Pharm Sci; 2021 Feb; 110(2):584-593. PubMed ID: 33058891
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling.
    García MA; Bolger MB; Suarez-Sharp S; Langguth P
    J Pharm Sci; 2022 Jan; 111(1):262-273. PubMed ID: 34678271
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.
    Pepin X; Arora S; Borges L; Cano-Vega M; Carducci T; Chatterjee P; Chen G; Cristofoletti R; Dallmann A; Delvadia P; Dressman J; Fotaki N; Gray E; Heimbach T; Holte Ø; Kijima S; Kotzagiorgis E; Lennernäs H; Lindahl A; Loebenberg R; Mackie C; Malamatari M; McAllister M; Mitra A; Moody R; Mudie D; Musuamba Tshinanu F; Polli JE; Rege B; Ren X; Rullo G; Scherholz M; Song I; Stillhart C; Suarez-Sharp S; Tannergren C; Tsakalozou E; Veerasingham S; Wagner C; Seo P
    Mol Pharm; 2024 Jun; ():. PubMed ID: 38946085
    [TBL] [Abstract][Full Text] [Related]  

  • 19. A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation.
    Aishwarya R; Murthy A; Ahmed T; Chachad S
    J Pharm Sci; 2022 Jun; 111(6):1820-1832. PubMed ID: 35217007
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development.
    Wu D; Li M
    Pharm Res; 2023 Feb; 40(2):321-336. PubMed ID: 36076007
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.