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1.

Concerns about the safety of obesity agents from a manufacturing perspective.

Kanfer I.

Postgrad Med. 2008 Jul;120(2):42-5. doi: 10.3810/pgm.2008.07.1789. Review.

PMID:
18654067
2.

What makes a generic medication generic?

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2009 Dec;47(12):17-20. doi: 10.3928/02793695-20091103-99.

PMID:
20000278
3.

Pharmacodynamic equivalence of two orlistat capsule formulations in healthy volunteers under fed conditions.

Di Marco M, Marier JF, Ducharme MP, Morin I, Engel C, Gulbranson S, Thudi NR, Murpani D, Rampal A, Monif T, Koundinya TS, Deo K, Monif T.

Int J Clin Pharmacol Ther. 2008 Jun;46(6):319-26.

PMID:
18541129
4.

A review of the safety of generic drugs.

Dighe SV.

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

PMID:
10330955
5.

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
6.

Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy.

Verbeeck RK, Kanfer I, Walker RB.

Eur J Pharm Sci. 2006 May;28(1-2):1-6. Epub 2006 Jan 18. Review.

PMID:
16413762
7.

Safety pharmacology of sibutramine mesylate, an anti-obesity drug.

Kim EJ, Park EK, Suh KH.

Hum Exp Toxicol. 2005 Mar;24(3):109-19.

PMID:
15901050
8.

Potential concerns about generic substitution: bioequivalence versus therapeutic equivalence of different amlodipine salt forms.

Meredith PA.

Curr Med Res Opin. 2009 Sep;25(9):2179-89. doi: 10.1185/03007990903116867. Review.

PMID:
19601710
9.

Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).

Taylor PW, Arnet I, Fischer A, Simpson IN.

Obes Facts. 2010 Aug;3(4):231-7. doi: 10.1159/000319450. Epub 2010 Aug 9.

PMID:
20823686
10.

International harmonization of bioequivalence studies and issues shared in common.

Nakai K, Fujita M, Ogata H.

Yakugaku Zasshi. 2000 Nov;120(11):1193-200.

PMID:
11190204
11.

Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs).

Raw AS, Furness MS, Gill DS, Adams RC, Holcombe FO Jr, Yu LX.

Adv Drug Deliv Rev. 2004 Feb 23;56(3):397-414. Review.

PMID:
14962589
12.

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
13.

[Pharmacological therapy of obesity].

Pagotto U, Vanuzzo D, Vicennati V, Pasquali R.

G Ital Cardiol (Rome). 2008 Apr;9(4 Suppl 1):83S-93S. Italian.

PMID:
18773755
14.

Residues of genotoxic alkyl mesylates in mesylate salt drug substances: real or imaginary problems?

Snodin DJ.

Regul Toxicol Pharmacol. 2006 Jun;45(1):79-90. Epub 2006 Mar 27.

PMID:
16564608
15.

Determination of therapeutic equivalence of generic products of gentamicin in the neutropenic mouse thigh infection model.

Zuluaga AF, Agudelo M, CardeƱo JJ, Rodriguez CA, Vesga O.

PLoS One. 2010 May 20;5(5):e10744. doi: 10.1371/journal.pone.0010744.

16.

Dissolution and in vivo evidence of differences in reference products: impact on development of generic drugs.

Spino M, Tsang YC, Pop R.

Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):18-24.

PMID:
11032084
17.

Adulteration of over-the-counter slimming products with pharmaceutical analogue--an emerging threat.

Yuen YP, Lai CK, Poon WT, Ng SW, Chan AY, Mak TW.

Hong Kong Med J. 2007 Jun;13(3):216-20.

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.

Investigation of solubility and dissolution of a free base and two different salt forms as a function of pH.

Li S, Wong S, Sethia S, Almoazen H, Joshi YM, Serajuddin AT.

Pharm Res. 2005 Apr;22(4):628-35. Epub 2005 Apr 7.

PMID:
15846471
20.

The effectiveness of generic agents in psychopharmacologic treatment.

Kumet R, Gelenberg AJ.

Essent Psychopharmacol. 2005;6(2):104-11. Review.

PMID:
15765794
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