367 related articles for article (PubMed ID: 10182892)
1. Generic drug product equivalence: current status.
Meyer MC
Am J Manag Care; 1998 Aug; 4(8):1183-9; quiz 1190-2. PubMed ID: 10182892
[TBL] [Abstract][Full Text] [Related]
2. United States Food and Drug Administration requirements for approval of generic drug products.
Meyer MC
J Clin Psychiatry; 2001; 62 Suppl 5():4-9; discussion 23-4. PubMed ID: 11305846
[TBL] [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
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. The need for additional metrics to assess therapeutic equivalence of some multiphasic modified-release products.
Kondra PM; Endrenyi L; Tothfalusi L
Clin Ther; 2011 Sep; 33(9):1214-9. PubMed ID: 21849209
[TBL] [Abstract][Full Text] [Related]
6. Generic warfarin: implications for clinical practice and perceptions of anticoagulation providers.
Bongiorno RA; Nutescu EA
Semin Thromb Hemost; 2004 Dec; 30(6):619-26. PubMed ID: 15630667
[TBL] [Abstract][Full Text] [Related]
7. Evaluating the bioavailability and bioequivalence of generic medications.
Howland RH
J Psychosoc Nurs Ment Health Serv; 2010 Jan; 48(1):13-6. PubMed ID: 20102127
[TBL] [Abstract][Full Text] [Related]
8. Generic substitution: issues for problematic drugs.
Henderson JD; Esham RH
South Med J; 2001 Jan; 94(1):16-21. PubMed ID: 11213935
[TBL] [Abstract][Full Text] [Related]
9. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.
Kesselheim AS; Polinski JM; Fulchino LA; Isaman DL; Gagne JJ
Drugs; 2015 Apr; 75(6):633-50. PubMed ID: 25822610
[TBL] [Abstract][Full Text] [Related]
10. Community pharmacists' understanding and perceptions of FDA therapeutic equivalence standards.
Euen BJ; Fadda HM
Res Social Adm Pharm; 2019 Jan; 15(1):77-83. PubMed ID: 29567088
[TBL] [Abstract][Full Text] [Related]
11. Lawsuits anticipated on generic biologicals front.
Fox JL
Nat Biotechnol; 2003 Jul; 21(7):721-2. PubMed ID: 12833078
[No Abstract] [Full Text] [Related]
12. What makes a generic medication generic?
Howland RH
J Psychosoc Nurs Ment Health Serv; 2009 Dec; 47(12):17-20. PubMed ID: 20000278
[TBL] [Abstract][Full Text] [Related]
13. The Food and Drug Administration and patent law at a crossroads: the listing of polymorph patents as a barrier to generic drug entry.
Srivastava D
Food Drug Law J; 2004; 59(2):339-54. PubMed ID: 15298015
[No Abstract] [Full Text] [Related]
14. The generic drug approval process.
Rheinstein PH
Am Fam Physician; 1993 Dec; 48(8):1357-60. PubMed ID: 8249762
[No Abstract] [Full Text] [Related]
15. A generic drug primer: regulatory aspects and scientific concepts.
Henderson JD; White GL
Mil Med; 1998 Apr; 163(4):193-7. PubMed ID: 9575760
[TBL] [Abstract][Full Text] [Related]
16. 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]
17. Wellbutrin versus generic bupropion.
Med Lett Drugs Ther; 2008 Jul; 50(1290):54-5. PubMed ID: 18617874
[No Abstract] [Full Text] [Related]
18. FDA position on product selection for 'narrow therapeutic index' drugs.
Am J Health Syst Pharm; 1997 Jul; 54(14):1630-2. PubMed ID: 9248609
[No Abstract] [Full Text] [Related]
19. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.
Kesselheim AS; Gagne JJ
Drug Saf; 2015 Oct; 38(10):849-53. PubMed ID: 26105011
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]
