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Results: 1 to 20 of 416

1.

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
[PubMed - indexed for MEDLINE]
2.

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
[PubMed - indexed for MEDLINE]
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.

PMID:
11305846
[PubMed - indexed for MEDLINE]
4.

Bioequivalence of generic thioridazine drug products--the FDA viewpoint.

Hamrell MR, Martinez MN, Dighe SV, Parkman PD.

Drug Intell Clin Pharm. 1987 Apr;21(4):362-72.

PMID:
3569040
[PubMed - indexed for MEDLINE]
5.

Regulatory aspects of modifications to innovator bronchodilator metered dose inhalers and development of generic substitutes.

Adams WP, Poochikian G, Taylor AS, Patel RM, Burke GP, Williams RL.

J Aerosol Med. 1994;7(2):119-34. Review.

PMID:
10147277
[PubMed - indexed for MEDLINE]
6.

Deficiencies of the FDA in evaluating generic formulations: addressing narrow therapeutic index drugs.

Hottinger M, Liang BA.

Am J Law Med. 2012;38(4):667-89.

PMID:
23356099
[PubMed - indexed for MEDLINE]
7.

Brand and generic medications: are they interchangeable?

Al-Jazairi AS, Bhareth S, Eqtefan IS, Al-Suwayeh SA.

Ann Saudi Med. 2008 Jan-Feb;28(1):33-41. Review.

PMID:
18299655
[PubMed - indexed for MEDLINE]
8.

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.

PMID:
22130775
[PubMed - indexed for MEDLINE]
Free PMC Article
9.

Bioequivalence and other unresolved issues in generic drug substitution.

Meredith P.

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

PMID:
14693311
[PubMed - indexed for MEDLINE]
10.

Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications.

Davit BM, Conner DP, Fabian-Fritsch B, Haidar SH, Jiang X, Patel DT, Seo PR, Suh K, Thompson CL, Yu LX.

AAPS J. 2008;10(1):148-56. doi: 10.1208/s12248-008-9015-x. Epub 2008 Mar 5.

PMID:
18446515
[PubMed - indexed for MEDLINE]
Free PMC Article
11.

Product selection, bioequivalence, and therapeutic equivalence: the generic drug market.

Halperin JA.

Drug Inf J. 1983;17(2):73-6.

PMID:
10263719
[PubMed - indexed for MEDLINE]
12.

Issues in the use of generic antiarrhythmic drugs.

Reiffel JA.

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

PMID:
11124715
[PubMed - indexed for MEDLINE]
13.

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
[PubMed - indexed for MEDLINE]
14.

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
[PubMed - indexed for MEDLINE]
15.

A generic drug primer: regulatory aspects and scientific concepts.

Henderson JD, White GL Jr.

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

PMID:
9575760
[PubMed - indexed for MEDLINE]
16.

Drug substitution in transplantation: a National Kidney Foundation White Paper.

Sabatini S, Ferguson RM, Helderman JH, Hull AR, Kirkpatrick BS, Barr WH.

Am J Kidney Dis. 1999 Feb;33(2):389-97. Review.

PMID:
10023656
[PubMed - indexed for MEDLINE]
17.

A review of the safety of generic drugs.

Dighe SV.

Transplant Proc. 1999 May;31(3A Suppl):23S-24S. Review.

PMID:
10330955
[PubMed - indexed for MEDLINE]
18.

Bioequivalence studies for levothyroxine.

Bolton S.

AAPS J. 2005 Mar 30;7(1):E47-53. Review.

PMID:
16146349
[PubMed - indexed for MEDLINE]
Free PMC Article
19.

Who needs individual bioequivalence studies for narrow therapeutic index drugs? A case for warfarin.

Yacobi A, Masson E, Moros D, Ganes D, Lapointe C, Abolfathi Z, LeBel M, Golander Y, Doepner D, Blumberg T, Cohen Y, Levitt B.

J Clin Pharmacol. 2000 Aug;40(8):826-35.

PMID:
10934666
[PubMed - indexed for MEDLINE]
20.

Critical therapeutic categories: a contraindication to generic substitution?

Colaizzi JL, Lowenthal DT.

Clin Ther. 1986;8(4):370-9.

PMID:
3731208
[PubMed - indexed for MEDLINE]

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