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 *

584 related articles for article (PubMed ID: 17554963)

  • 21. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.
    Chen ML; Shah VP; Crommelin DJ; Shargel L; Bashaw D; Bhatti M; Blume H; Dressman J; Ducharme M; Fackler P; Hyslop T; Lutter L; Morais J; Ormsby E; Thomas S; Tsang YC; Velagapudi R; Yu LX
    Eur J Pharm Sci; 2011 Nov; 44(4):506-13. PubMed ID: 21946259
    [TBL] [Abstract][Full Text] [Related]  

  • 22. [Generic drugs, bioavailability, and bioequivalence].
    Palma-Aguirre JA
    Gac Med Mex; 1998; 134(4):491-4. PubMed ID: 9789395
    [No Abstract]   [Full Text] [Related]  

  • 23. Requirements for submission of bioequivalence data; final rule. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Jan; 74(11):2849-62. PubMed ID: 19385107
    [TBL] [Abstract][Full Text] [Related]  

  • 24. [Trends in the quality evaluation of generic products and bioequivalence guidelines].
    Yomota C
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2012; (130):1-12. PubMed ID: 23243982
    [TBL] [Abstract][Full Text] [Related]  

  • 25. 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]  

  • 26. Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products.
    Wang R; Conner DP; Li BV
    AAPS J; 2017 Mar; 19(2):360-366. PubMed ID: 28004346
    [TBL] [Abstract][Full Text] [Related]  

  • 27. The scope and requirements related to preclinical and clinical studies of a new medicinal product, including biotechnological and biosimilar products.
    Brodniewicz-Proba T
    Acta Pol Pharm; 2008; 65(6):641-5. PubMed ID: 19172845
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Viewpoint: observations on scaled average bioequivalence.
    Patterson SD; Jones B
    Pharm Stat; 2012; 11(1):1-7. PubMed ID: 22162308
    [TBL] [Abstract][Full Text] [Related]  

  • 29. International harmonization of bioequivalence studies and issues shared in common.
    Nakai K; Fujita M; Ogata H
    Yakugaku Zasshi; 2000 Nov; 120(11):1193-200. PubMed ID: 11190204
    [TBL] [Abstract][Full Text] [Related]  

  • 30. Comments on the note for guidance on bioavailability and bioequivalence in the European Union.
    Calvo G
    Methods Find Exp Clin Pharmacol; 1998; 20 Suppl A():11. PubMed ID: 9800721
    [No Abstract]   [Full Text] [Related]  

  • 31. Generics and cost-effective prescribing in Belgium: does bioequivalence always translate in therapeutic equivalence?
    Dupont AG; Heller F
    Acta Clin Belg; 2009; 64(5):406-14. PubMed ID: 19999388
    [TBL] [Abstract][Full Text] [Related]  

  • 32. The new European Medicines Agency guideline on the investigation of bioequivalence.
    Morais JA; Lobato Mdo R
    Basic Clin Pharmacol Toxicol; 2010 Mar; 106(3):221-5. PubMed ID: 20070293
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Bioequivalence of generic and branded subcutaneous enoxaparin: a single-dose, randomized-sequence, open-label, two-period crossover study in healthy Chinese male subjects.
    Feng L; Shen-Tu J; Liu J; Chen J; Wu L; Huang M
    Clin Ther; 2009 Jul; 31(7):1559-67. PubMed ID: 19695405
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Novel approach to bioequivalence assessment based on physiologically motivated model.
    Tvrdonova M; Chrenova J; Rausova Z; Miklovicova D; Durisova M; Mircioiu C; Dedik L
    Int J Pharm; 2009 Oct; 380(1-2):89-95. PubMed ID: 19596057
    [TBL] [Abstract][Full Text] [Related]  

  • 35. Bioequivalence study of three generic formulations of co-trimoxazole tablets in human urine.
    Ilupeju TO; Oladeinde FO; Olaniyi AA; Amosu MA
    Afr J Med Med Sci; 2004 Dec; 33(4):341-5. PubMed ID: 15977442
    [TBL] [Abstract][Full Text] [Related]  

  • 36. Current regulatory approaches of bioequivalence testing.
    Karalis V; Macheras P
    Expert Opin Drug Metab Toxicol; 2012 Aug; 8(8):929-42. PubMed ID: 22681436
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Modeling and simulation of biopharmaceutical performance.
    Zhang X; Lionberger RA
    Clin Pharmacol Ther; 2014 May; 95(5):480-2. PubMed ID: 24747237
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Generics and substitution modalities: proposed methods for the evaluation of equivalence, traceability and pharmacovigilance reporting.
    Lamarque V; Merle L; Demarez JP;
    Therapie; 2008; 63(4):301-9. PubMed ID: 18937910
    [TBL] [Abstract][Full Text] [Related]  

  • 39. The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation.
    Jiang W; Kim S; Zhang X; Lionberger RA; Davit BM; Conner DP; Yu LX
    Int J Pharm; 2011 Oct; 418(2):151-60. PubMed ID: 21803144
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Establishment of in vitro-in vivo equivalence of highly variable drugs - a generic product development perspective.
    Pathak SM; Aggarwal D; Venkateswarlu V
    Pharm Dev Technol; 2014 Jun; 19(4):401-10. PubMed ID: 23607272
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 30.