Format
Sort by

Send to

Choose Destination

Links from PubMed

Items: 1 to 20 of 166

1.

Generic drug product equivalence: current status.

Meyer MC.

Am J Manag Care. 1998 Aug;4(8):1183-9; quiz 1190-2.

2.

A generic drug primer: regulatory aspects and scientific concepts.

Henderson JD, White GL Jr.

Mil Med. 1998 Apr;163(4):193-7.

PMID:
9575760
3.

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. Review.

4.

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. doi: 10.1345/aph.1M141. Epub 2009 Sep 23.

PMID:
19776300
5.

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 20;44(4):506-13. doi: 10.1016/j.ejps.2011.09.010. Epub 2011 Sep 16.

PMID:
21946259
6.

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.

AAPS J. 2011 Dec;13(4):556-64. doi: 10.1208/s12248-011-9294-5. Epub 2011 Aug 16.

7.
8.

FDA position on product selection for 'narrow therapeutic index' drugs.

[No authors listed]

Am J Health Syst Pharm. 1997 Jul 15;54(14):1630-2. No abstract available.

PMID:
9248609
9.

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. doi: 10.1016/j.clinthera.2011.07.014. Epub 2011 Aug 17.

PMID:
21849209
10.

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. doi: 10.1007/s40265-015-0382-1. Review.

PMID:
25822610
11.

Pharmaceutical equivalence by design for generic drugs: modified-release products.

Raw AS, Lionberger R, Yu LX.

Pharm Res. 2011 Jul;28(7):1445-53. doi: 10.1007/s11095-011-0397-6. Epub 2011 Mar 9.

PMID:
21387150
12.
13.

Issues in the use of generic antiarrhythmic drugs.

Reiffel JA.

Curr Opin Cardiol. 2001 Jan;16(1):23-9. Review.

PMID:
11124715
14.

Bioequivalence and other unresolved issues in generic drug substitution.

Meredith P.

Clin Ther. 2003 Nov;25(11):2875-90.

PMID:
14693311
15.

Generic warfarin: implications for clinical practice and perceptions of anticoagulation providers.

Bongiorno RA, Nutescu EA.

Semin Thromb Hemost. 2004 Dec;30(6):619-26.

PMID:
15630667
16.

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.

Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, Lionberger RA, Makhlouf FT, Nwakama PE, Patel DT, Schuirmann DJ, Yu LX.

AAPS J. 2012 Dec;14(4):915-24. doi: 10.1208/s12248-012-9406-x. Epub 2012 Sep 13. Review.

17.

Physicians are concerned about generic drug bioequivalence, but often unaware of FDA standards.

[No authors listed]

Am J Health Syst Pharm. 1997 Dec 15;54(24):2799-800. No abstract available.

PMID:
9428948
18.

Evaluating the bioavailability and bioequivalence of generic medications.

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2010 Jan;48(1):13-6. doi: 10.3928/02793695-20091204-07.

PMID:
20102127
19.

Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA.

Liu Q, Davit BM, Cherstniakova SA, Dandamudi S, Walters JF, Lee CH, Raines KW, Ren K, Williamson LN, Conner DP.

AAPS J. 2012 Mar;14(1):19-22. doi: 10.1208/s12248-011-9312-7. Epub 2011 Dec 1.

20.

Generic substitution: issues for problematic drugs.

Henderson JD, Esham RH.

South Med J. 2001 Jan;94(1):16-21. Review. Erratum in: South Med J. 2001 Dec;94(12):1235.

PMID:
11213935
Items per page

Supplemental Content

Write to the Help Desk