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Items: 1 to 20 of 89

1.

How do you define equivalence of the API of biomass products?

Hunter RP, DeRidder E, Lucas A, Smedley KO, Yordy DW.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:99-101. doi: 10.1111/j.1365-2885.2012.01374.x. No abstract available.

PMID:
22413797
2.

Establishing bioequivalence of veterinary premixes (Type A medicated articles).

Hunter RP, Lees P, Concordet D, Toutain PL.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:53-63. doi: 10.1111/j.1365-2885.2012.01368.x.

PMID:
22413792
3.

Challenges associated with the demonstration of bioequivalence of intramammary products in ruminants.

Lainesse C, Gehring R, Pasloske K, Smith G, Soback S, Wagner S, Whittem T.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:65-79. doi: 10.1111/j.1365-2885.2012.01375.x.

PMID:
22413793
4.

Current challenges facing the determination of product bioequivalence in veterinary medicine.

Martinez MN, Hunter RP.

J Vet Pharmacol Ther. 2010 Oct;33(5):418-33. doi: 10.1111/j.1365-2885.2010.01180.x. Review.

PMID:
20840385
5.

Demonstrating bioequivalence using clinical endpoint studies.

Bermingham E, Del Castillo JR, Lainesse C, Pasloske K, Radecki S.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:31-7. doi: 10.1111/j.1365-2885.2012.01366.x.

PMID:
22413789
6.

Estimating product bioequivalence for highly variable veterinary drugs.

Claxton R, Cook J, Endrenyi L, Lucas A, Martinez MN, Sutton SC.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:11-6. doi: 10.1111/j.1365-2885.2012.01376.x.

PMID:
22413787
7.

The 2010 AAVPT/EAVPT/ECVPT bioequivalence workshop.

Martinez M, Hunter RP, Baynes R, Bermingham E, Claxton R, Cole C, Del Castillo J, Gehring R, Harshman K, Lainesse C, Lucas A, Modric S, Robinson J.

J Vet Pharmacol Ther. 2011 Apr;34(2):105-7. doi: 10.1111/j.1365-2885.2011.01281.x. Epub 2011 Feb 17. No abstract available.

PMID:
21395599
8.

A SAS/IML program for simulating pharmacokinetic data.

Russek-Cohen E, Martinez MN, Nevius AB.

Comput Methods Programs Biomed. 2005 Apr;78(1):39-60.

PMID:
15780889
9.

Considerations for extrapolating in vivo bioequivalence data across species and routes.

Modric S, Bermingham E, Heit M, Lainesse C, Thompson C.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:45-52. doi: 10.1111/j.1365-2885.2012.01365.x.

PMID:
22413791
10.

Challenges and opportunities in animal drug development: a regulatory perspective.

Lathers CM.

Nat Rev Drug Discov. 2003 Nov;2(11):915-8. Review. No abstract available.

PMID:
14560318
11.

Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective.

Martinez M, Langston C, Martin T, Conner D.

J Vet Pharmacol Ther. 2002 Jun;25(3):201-20.

PMID:
12081616
12.

Introduction to the bioequivalence theme issue.

Martinez MN, Hunter RP.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:1-2. doi: 10.1111/j.1365-2885.2012.01371.x. No abstract available.

PMID:
22413785
13.

Veterinary drug bioequivalence determination.

Toutain PL, Koritz GD.

J Vet Pharmacol Ther. 1997 Apr;20(2):79-90. Review.

PMID:
9131533
14.

Bioequivalence accomplishments, ongoing initiatives, and remaining challenges.

Martinez MN.

J Vet Pharmacol Ther. 2014 Feb;37(1):2-12. doi: 10.1111/jvp.12063. Epub 2013 Jul 11. Review.

PMID:
23841644
15.

Challenges obtaining a biowaiver for topical veterinary dosage forms.

Baynes R, Riviere J, Franz T, Monteiro-Riviere N, Lehman P, Peyrou M, Toutain PL.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:103-14. doi: 10.1111/j.1365-2885.2012.01381.x.

PMID:
22413798
16.

Pharmacokinetics and pharmacodynamics of stereoisomeric drugs with particular reference to bioequivalence determination.

Lees P, Hunter RP, Reeves PT, Toutain PL.

J Vet Pharmacol Ther. 2012 Apr;35 Suppl 1:17-29. doi: 10.1111/j.1365-2885.2012.01367.x. Review.

PMID:
22413788
17.

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.

18.

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
19.
20.

The rise of the biosimilar.

McCamish M, Woollett G.

Expert Rev Clin Pharmacol. 2012 Nov;5(6):597-9. doi: 10.1586/ecp.12.60. No abstract available.

PMID:
23234317

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