BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

284 related articles for article (PubMed ID: 33759204)

  • 21. The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted.
    Benet LZ; Larregieu CA
    Clin Pharmacol Ther; 2010 Sep; 88(3):405-7. PubMed ID: 20668447
    [TBL] [Abstract][Full Text] [Related]  

  • 22. Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays.
    Miranda-Pérez de Alejo C; Aceituno Álvarez A; Mendes Lima Santos G; Fernández Cervera M; Jung-Cook H; Cabrera-Pérez MÁ
    Ther Innov Regul Sci; 2021 Jan; 55(1):65-81. PubMed ID: 32602028
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine.
    García MA; Cristofoletti R; Abrahamsson B; Groot DW; Parr A; Polli JE; Mehta M; Shah VP; Tomakazu T; Dressman JB; Langguth P
    J Pharm Sci; 2021 May; 110(5):1935-1947. PubMed ID: 33610571
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Pharmacokinetic simulations to explore dissolution criteria of BCS I and III biowaivers with and without MDR-1 efflux transporter.
    Kortejärvi H; Malkki J; Shawahna R; Scherrmann JM; Urtti A; Yliperttula M
    Eur J Pharm Sci; 2014 Sep; 61():18-26. PubMed ID: 24566614
    [TBL] [Abstract][Full Text] [Related]  

  • 25. The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation.
    Tsume Y; Amidon GL
    Mol Pharm; 2010 Aug; 7(4):1235-43. PubMed ID: 20557130
    [TBL] [Abstract][Full Text] [Related]  

  • 26. A Physiologically Based Pharmacokinetic Model for Studying the Biowaiver Risk of Biopharmaceutics Classification System Class I Drugs With Rapid Elimination: Dexketoprofen Trometamol Case Study.
    Zhang X; Ye X; Hu K; Li W; Li W; Xiao Q; Chen L; Yang J
    Front Pharmacol; 2022; 13():808456. PubMed ID: 35273497
    [TBL] [Abstract][Full Text] [Related]  

  • 27. Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses.
    Chow EC; Talattof A; Tsakalozou E; Fan J; Zhao L; Zhang X
    AAPS J; 2016 Nov; 18(6):1500-1511. PubMed ID: 27520379
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies.
    Mishra V; Gupta U; Jain NK
    Pharmazie; 2010 Mar; 65(3):155-61. PubMed ID: 20383933
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.
    Plöger GF; Quizon PM; Abrahamsson B; Cristofoletti R; Groot DW; Parr A; Langguth P; Polli JE; Shah VP; Tajiri T; Mehta MU; Dressman J
    J Pharm Sci; 2020 Jun; 109(6):1846-1862. PubMed ID: 32240696
    [TBL] [Abstract][Full Text] [Related]  

  • 30. An investigation into the importance of "very rapid dissolution" criteria for drug bioequivalence demonstration using gastrointestinal simulation technology.
    Kovacevi I; Parojci J; Tubi-Grozdanis M; Langguth P
    AAPS J; 2009 Jun; 11(2):381-4. PubMed ID: 19455428
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Solubility Determination of Active Pharmaceutical Ingredients Which Have Been Recently Added to the List of Essential Medicines in the Context of the Biopharmaceutics Classification System-Biowaiver.
    Plöger GF; Hofsäss MA; Dressman JB
    J Pharm Sci; 2018 Jun; 107(6):1478-1488. PubMed ID: 29421214
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Investigating the Discriminatory Power of BCS-Biowaiver in Vitro Methodology to Detect Bioavailability Differences between Immediate Release Products Containing a Class I Drug.
    Colón-Useche S; González-Álvarez I; Mangas-Sanjuan V; González-Álvarez M; Pastoriza P; Molina-Martínez I; Bermejo M; García-Arieta A
    Mol Pharm; 2015 Sep; 12(9):3167-74. PubMed ID: 26287948
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Risk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population.
    Charoo NA; Cristofoletti R; Dressman JB
    J Pharm Pharmacol; 2015 Aug; 67(8):1156-69. PubMed ID: 25828546
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.
    Charoo NA; Abdallah DB; Parveen T; Abrahamsson B; Cristofoletti R; Groot DW; Langguth P; Parr A; Polli JE; Mehta M; Shah VP; Tajiri T; Dressman J
    J Pharm Sci; 2020 Sep; 109(9):2654-2675. PubMed ID: 32534881
    [TBL] [Abstract][Full Text] [Related]  

  • 35. Scientific considerations concerning the EMA change in the definition of "dose" of the BCS-based biowaiver guideline and implications for bioequivalence.
    Daousani C; Macheras P
    Int J Pharm; 2015 Jan; 478(2):606-9. PubMed ID: 25437115
    [TBL] [Abstract][Full Text] [Related]  

  • 36. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate.
    Charoo NA; Abdallah DB; Bakheit AA; Haque KU; Hassan HA; Abrahamsson B; Cristofoletti R; Langguth P; Mehta M; Parr A; Polli JE; Shah VP; Tajiri T; Dressman J
    J Pharm Sci; 2022 Jan; 111(1):2-13. PubMed ID: 34597625
    [TBL] [Abstract][Full Text] [Related]  

  • 37. In Vitro In Vivo Extrapolation and Bioequivalence Prediction for Immediate-Release Capsules of Cefadroxil Based on a Physiologically-Based Pharmacokinetic ACAT Model.
    Rahim N; Naqvi SBS
    AAPS PharmSciTech; 2024 May; 25(5):100. PubMed ID: 38714602
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Biowaiver extension potential and IVIVC for BCS Class II drugs by formulation design: Case study for cyclosporine self-microemulsifying formulation.
    Yang SG
    Arch Pharm Res; 2010 Nov; 33(11):1835-42. PubMed ID: 21116787
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine.
    Charoo NA; Selvasudha N; Kath ZN; Abrahamsson B; Cristofoletti R; Kambayashi A; Langguth P; Mehta M; Parr A; Polli JE; Shah VP; Dressman J
    J Pharm Sci; 2024 Jun; ():. PubMed ID: 38857646
    [TBL] [Abstract][Full Text] [Related]  

  • 40. 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]  

    [Previous]   [Next]    [New Search]
    of 15.