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 *

168 related articles for article (PubMed ID: 18500563)

  • 21. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 12, 413-420, 1995--backstory of BCS.
    Shah VP; Amidon GL
    AAPS J; 2014 Sep; 16(5):894-8. PubMed ID: 24961917
    [TBL] [Abstract][Full Text] [Related]  

  • 22. 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]  

  • 23. In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies.
    Kollipara S; Ahmed T; Bhattiprolu AK; Chachad S
    Biopharm Drug Dispos; 2021 Jul; 42(7):297-318. PubMed ID: 34019712
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products: cimetidine.
    Jantratid E; Prakongpan S; Amidon GL; Dressman JB
    Clin Pharmacokinet; 2006; 45(4):385-99. PubMed ID: 16584285
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Current and evolving approaches for improving the oral permeability of BCS Class III or analogous molecules.
    Dave VS; Gupta D; Yu M; Nguyen P; Varghese Gupta S
    Drug Dev Ind Pharm; 2017 Feb; 43(2):177-189. PubMed ID: 27998192
    [TBL] [Abstract][Full Text] [Related]  

  • 26. 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]  

  • 27. The Discriminatory Power of the BCS-Based Biowaiver: A Retrospective With Focus on Essential Medicines.
    Hofsäss MA; Dressman JB
    J Pharm Sci; 2019 Sep; 108(9):2824-2837. PubMed ID: 31059698
    [TBL] [Abstract][Full Text] [Related]  

  • 28. The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines.
    Charalabidis A; Sfouni M; Bergström C; Macheras P
    Int J Pharm; 2019 Jul; 566():264-281. PubMed ID: 31108154
    [TBL] [Abstract][Full Text] [Related]  

  • 29. The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers.
    Parr A; Hidalgo IJ; Bode C; Brown W; Yazdanian M; Gonzalez MA; Sagawa K; Miller K; Jiang W; Stippler ES
    Pharm Res; 2016 Jan; 33(1):167-76. PubMed ID: 26286187
    [TBL] [Abstract][Full Text] [Related]  

  • 30. 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]  

  • 31. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system.
    Lindenberg M; Kopp S; Dressman JB
    Eur J Pharm Biopharm; 2004 Sep; 58(2):265-78. PubMed ID: 15296954
    [TBL] [Abstract][Full Text] [Related]  

  • 32. 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]  

  • 33. Impact of Biopharmaceutics Classification System-based biowaivers.
    Cook JA; Davit BM; Polli JE
    Mol Pharm; 2010 Oct; 7(5):1539-44. PubMed ID: 20735084
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Bioequivalence and generic prescribing: an industrial view.
    Pidgen A
    J Pharm Pharmacol; 1996 Jan; 48(1):11-6. PubMed ID: 8722487
    [TBL] [Abstract][Full Text] [Related]  

  • 35. Provisional classification and in silico study of biopharmaceutical system based on caco-2 cell permeability and dose number.
    Pham-The H; Garrigues T; Bermejo M; González-Álvarez I; Monteagudo MC; Cabrera-Pérez MÁ
    Mol Pharm; 2013 Jun; 10(6):2445-61. PubMed ID: 23675957
    [TBL] [Abstract][Full Text] [Related]  

  • 36. Innovative in vitro methodologies for establishing therapeutic equivalence.
    Murray L; Arias A; Li J; Bhoopathy S; Hidalgo IJ
    Rev Panam Salud Publica; 2016 Aug; 40(1):23-28. PubMed ID: 27706385
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Clinical relevance of dissolution testing in quality by design.
    Dickinson PA; Lee WW; Stott PW; Townsend AI; Smart JP; Ghahramani P; Hammett T; Billett L; Behn S; Gibb RC; Abrahamsson B
    AAPS J; 2008 Jun; 10(2):380-90. PubMed ID: 18686045
    [TBL] [Abstract][Full Text] [Related]  

  • 38. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
    Chen ML; Blume H; Beuerle G; Davit B; Mehta M; Potthast H; Schug B; Tsang YC; Wedemeyer RS; Weitschies W; Welink J
    Eur J Pharm Sci; 2018 Jan; 111():153-157. PubMed ID: 28964950
    [TBL] [Abstract][Full Text] [Related]  

  • 39. A non-binary biopharmaceutical classification of drugs: the ABΓ system.
    Macheras P; Karalis V
    Int J Pharm; 2014 Apr; 464(1-2):85-90. PubMed ID: 24456673
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Leveraging BCS in Development: A Case Study.
    Hoaglund Hyzer CS; Fadda HM; Rodriguez JO; Aburub A
    Mol Pharm; 2015 Oct; 12(10):3685-90. PubMed ID: 26365521
    [TBL] [Abstract][Full Text] [Related]  

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