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Journal Abstract Search

533 related items for PubMed ID: 21637264

  • 1. The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.
    Kefalas CH, Ciociola AA.
    Am J Gastroenterol; 2011 Jun; 106(6):1018-21. PubMed ID: 21637264
    [No Abstract] [Full Text] [Related]

  • 2. Generic and alternative brand-name pharmaceutical equivalents: select with caution.
    Hendeles L, Hochhaus G, Kazerounian S.
    Am J Hosp Pharm; 1993 Feb; 50(2):323-9. PubMed ID: 8480793
    [No Abstract] [Full Text] [Related]

  • 3. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
    Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J.
    Ann Pharmacother; 2009 Oct; 43(10):1583-97. PubMed ID: 19776300
    [Abstract] [Full Text] [Related]

  • 4. How does the FDA's drug approval process work?
    Miller DJ.
    ONS Connect; 2014 Jun; 29(2):43. PubMed ID: 24961046
    [No Abstract] [Full Text] [Related]

  • 5. The generic drug approval process.
    Rheinstein PH.
    Am Fam Physician; 1993 Dec; 48(8):1357-60. PubMed ID: 8249762
    [No Abstract] [Full Text] [Related]

  • 6. Generic drug approval: a US perspective.
    Nagori BP, Mathur V, Garg S.
    Curr Med Res Opin; 2011 Mar; 27(3):541-5. PubMed ID: 21219120
    [Abstract] [Full Text] [Related]

  • 7. Investigational drug tracking: phases I-III and NDA submissions--Part II.
    Grant KL.
    Hosp Pharm; 1994 Oct; 29(10):900, 902-4, 906-11 passim. PubMed ID: 10137850
    [Abstract] [Full Text] [Related]

  • 8. United States Food and Drug Administration requirements for approval of generic drug products.
    Meyer MC.
    J Clin Psychiatry; 2001 Oct; 62 Suppl 5():4-9; discussion 23-4. PubMed ID: 11305846
    [Abstract] [Full Text] [Related]

  • 9. The FDA's drug review process: ensuring drugs are safe and effective.
    Meadows M.
    FDA Consum; 2002 Oct; 36(4):19-24. PubMed ID: 12184298
    [No Abstract] [Full Text] [Related]

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

  • 11. Critical therapeutic categories: a contraindication to generic substitution?
    Colaizzi JL, Lowenthal DT.
    Clin Ther; 1986 May; 8(4):370-9. PubMed ID: 3731208
    [Abstract] [Full Text] [Related]

  • 12. Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.
    Kesselheim AS, Eddings W, Raj T, Campbell EG, Franklin JM, Ross KM, Fulchino LA, Avorn J, Gagne JJ.
    PLoS One; 2016 May; 11(10):e0163339. PubMed ID: 27768700
    [Abstract] [Full Text] [Related]

  • 13. How pharmacogenomics will impact the federal regulation of clinical trials and the new drug approval process.
    Binzak BA.
    Food Drug Law J; 2003 May; 58(1):103-27. PubMed ID: 12739592
    [No Abstract] [Full Text] [Related]

  • 14. Generic Drugs.
    Med Lett Drugs Ther; 2002 Oct 14; 44(1141):89-90. PubMed ID: 12405134
    [No Abstract] [Full Text] [Related]

  • 15. Lawsuits anticipated on generic biologicals front.
    Fox JL.
    Nat Biotechnol; 2003 Jul 14; 21(7):721-2. PubMed ID: 12833078
    [No Abstract] [Full Text] [Related]

  • 16. Initial responses to recommendations of the Blue Ribbon Committee on Generic Medicines.
    Heller WM.
    Am J Hosp Pharm; 1993 Feb 14; 50(2):318-22. PubMed ID: 8480792
    [No Abstract] [Full Text] [Related]

  • 17. What makes a generic medication generic?
    Howland RH.
    J Psychosoc Nurs Ment Health Serv; 2009 Dec 14; 47(12):17-20. PubMed ID: 20000278
    [Abstract] [Full Text] [Related]

  • 18. Evaluating the bioavailability and bioequivalence of generic medications.
    Howland RH.
    J Psychosoc Nurs Ment Health Serv; 2010 Jan 14; 48(1):13-6. PubMed ID: 20102127
    [Abstract] [Full Text] [Related]

  • 19. FDA's role in making exclusivity determinations.
    Dickinson EH.
    Food Drug Law J; 1999 Jan 14; 54(2):195-203. PubMed ID: 11758573
    [No Abstract] [Full Text] [Related]

  • 20. FDA mulls changes to bioequivalence standards.
    Traynor K.
    Am J Health Syst Pharm; 2010 Jun 01; 67(11):864. PubMed ID: 20484205
    [No Abstract] [Full Text] [Related]

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