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Items: 1 to 20 of 46

1.

Generic drug product equivalence: current status.

Meyer MC.

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

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. Review.

3.

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
4.

Issues in the use of generic antiarrhythmic drugs.

Reiffel JA.

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

PMID:
11124715
5.

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
6.

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.

7.

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
8.

Bioequivalence testing of immunosuppressants: concepts and misconceptions.

Christians U, Klawitter J, Clavijo CF.

Kidney Int Suppl. 2010 Mar;(115):S1-7. doi: 10.1038/ki.2009.504. Review.

PMID:
20150904
9.

Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review.

van der Meersch A, Dechartres A, Ravaud P.

PLoS One. 2011;6(8):e23611. doi: 10.1371/journal.pone.0023611. Epub 2011 Aug 17. Review.

10.

A review of the safety of generic drugs.

Dighe SV.

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

PMID:
10330955
11.

Understanding the scientific issues embedded in the generic drug approval process.

Welage LS, Kirking DM, Ascione FJ, Gaither CA.

J Am Pharm Assoc (Wash). 2001 Nov-Dec;41(6):856-67. Review.

PMID:
11765111
12.

Regulatory considerations for generic or biosimilar low molecular weight heparins.

García-Arieta A, Blázquez A.

Curr Drug Discov Technol. 2012 Jun 1;9(2):137-42. Review.

PMID:
21838658
13.

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
14.

Some thoughts on drug interchangeability.

Chow SC, Song F, Chen M.

J Biopharm Stat. 2016;26(1):178-86. doi: 10.1080/10543406.2015.1092027. Review.

PMID:
26366703
15.

Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.

Choi SH, Lionberger RA.

AAPS J. 2016 Jul;18(4):1032-8. doi: 10.1208/s12248-016-9932-z. Epub 2016 May 16. Review.

PMID:
27184578
16.

Bioavailability and bioequivalence: an FDA regulatory overview.

Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, Williams R.

Pharm Res. 2001 Dec;18(12):1645-50. Review.

PMID:
11785681
17.

Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

van Gelder T, Gabardi S.

Transpl Int. 2013 Aug;26(8):771-7. doi: 10.1111/tri.12074. Epub 2013 Feb 27. Review.

18.

FDA critical path initiatives: opportunities for generic drug development.

Lionberger RA.

AAPS J. 2008;10(1):103-9. doi: 10.1208/s12248-008-9010-2. Epub 2008 Feb 20. Review.

19.

Selection of oral controlled-release drugs: a critical decision for the physician.

Arnold RJ, Kaniecki DJ.

South Med J. 1993 Feb;86(2):208-14. Review.

PMID:
8434294
20.

Bioequivalence studies for levothyroxine.

Bolton S.

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

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