BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

164 related articles for article (PubMed ID: 38043684)

  • 21. 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]  

  • 22. Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics - a case study and utility in regulatory justifications.
    Boddu R; Kollipara S; Bhattiprolu AK; Ahmed T
    Xenobiotica; 2023; 53(10-11):587-602. PubMed ID: 38062540
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.
    Heimbach T; Suarez-Sharp S; Kakhi M; Holmstock N; Olivares-Morales A; Pepin X; Sjögren E; Tsakalozou E; Seo P; Li M; Zhang X; Lin HP; Montague T; Mitra A; Morris D; Patel N; Kesisoglou F
    AAPS J; 2019 Feb; 21(2):29. PubMed ID: 30746576
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets.
    Jaiswal S; Ahmed T; Kollipara S; Bhargava M; Chachad S
    Drug Dev Ind Pharm; 2021 May; 47(5):778-789. PubMed ID: 34082622
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Integrating In Vitro Biopharmaceutics into Physiologically Based Biopharmaceutic Model (PBBM) to Predict Food Effect of BCS IV Zwitterionic Drug (GSK3640254).
    Stamatopoulos K; Ferrini P; Nguyen D; Zhang Y; Butler JM; Hall J; Mistry N
    Pharmaceutics; 2023 Feb; 15(2):. PubMed ID: 36839843
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Physiologically Based Biopharmaceutics Modeling of Food Effect for Basmisanil: A Retrospective Case Study of the Utility for Formulation Bridging.
    Belubbi T; Bassani D; Stillhart C; Parrott N
    Pharmaceutics; 2023 Jan; 15(1):. PubMed ID: 36678820
    [TBL] [Abstract][Full Text] [Related]  

  • 27. Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies.
    Kajiwara E; Kamizato H; Shikano M
    Ther Innov Regul Sci; 2021 Sep; 55(5):1096-1100. PubMed ID: 34097289
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.
    Pepin XJH; Parrott N; Dressman J; Delvadia P; Mitra A; Zhang X; Babiskin A; Kolhatkar V; Suarez-Sharp S
    J Pharm Sci; 2021 Feb; 110(2):555-566. PubMed ID: 32380182
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Acalabrutinib Maleate Tablets: The Physiologically Based Biopharmaceutics Model behind the Drug Product Dissolution Specification.
    Pepin X; McAlpine V; Moir A; Mann J
    Mol Pharm; 2023 Apr; 20(4):2181-2193. PubMed ID: 36859819
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Physiologically Based Biopharmaceutics Model for Selumetinib Food Effect Investigation and Capsule Dissolution Safe Space - Part I: Adults.
    Pepin XJH; Hammarberg M; Mattinson A; Moir A
    Pharm Res; 2023 Feb; 40(2):387-403. PubMed ID: 36002614
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.
    Tampal N; Mandula H; Zhang H; Li BV; Nguyen H; Conner DP
    AAPS PharmSciTech; 2015 Feb; 16(1):5-9. PubMed ID: 25245330
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Development of Extended-Release Mini-Tablets Containing Metoprolol Supported by Design of Experiments and Physiologically Based Biopharmaceutics Modeling.
    Issa MG; de Souza NV; Jou BWC; Duque MD; Ferraz HG
    Pharmaceutics; 2022 Apr; 14(5):. PubMed ID: 35631478
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies.
    Karnati P; Murthy A; Gundeti M; Ahmed T
    AAPS J; 2023 Jun; 25(4):63. PubMed ID: 37353655
    [TBL] [Abstract][Full Text] [Related]  

  • 34. 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]  

  • 35. Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen.
    Loisios-Konstantinidis I; Cristofoletti R; Fotaki N; Turner DB; Dressman J
    Eur J Pharm Sci; 2020 Feb; 143():105170. PubMed ID: 31783158
    [TBL] [Abstract][Full Text] [Related]  

  • 36. PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development.
    Rebeka J; Jerneja O; Igor L; Boštjan P; Aleksander B; Simon Ž; Albin K
    AAPS PharmSciTech; 2019 Jan; 20(2):59. PubMed ID: 30623248
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Prediction of pH-Dependent Drug-Drug Interactions for Basic Drugs Using Physiologically Based Biopharmaceutics Modeling: Industry Case Studies.
    Mitra A; Parrott N; Miller N; Lloyd R; Tistaert C; Heimbach T; Ji Y; Kesisoglou F
    J Pharm Sci; 2020 Mar; 109(3):1380-1394. PubMed ID: 31778721
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol.
    Macwan JS; Fraczkiewicz G; Bertolino M; Krüger P; Peters SA
    CPT Pharmacometrics Syst Pharmacol; 2021 Jun; 10(6):622-632. PubMed ID: 34080804
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Approaches of formulation bridging in support of orally administered drug product development.
    Han M; Xu J; Lin Y
    Int J Pharm; 2022 Dec; 629():122380. PubMed ID: 36368608
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039.
    Kourentas A; Gajewska M; Lin W; Dhareshwar SS; Steib-Lauer C; Kulkarni S; Hirsch S; Heimbach T; Mueller-Zsigmondy M
    AAPS J; 2023 Feb; 25(1):25. PubMed ID: 36788163
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 9.