Tothfalusi L - Search Results

1

An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence.

Tothfalusi L, Endrenyi L. Tothfalusi L, et al. AAPS J. 2016 Mar;18(2):476-89. doi: 10.1208/s12248-016-9873-6. Epub 2016 Jan 29. AAPS J. 2016. PMID: 26831249 Free PMC article.

2

Limits for the scaled average bioequivalence of highly variable drugs and drug products.

Tothfalusi L, Endrenyi L. Tothfalusi L, et al. Pharm Res. 2003 Mar;20(3):382-9. doi: 10.1023/a:1022695819135. Pharm Res. 2003. PMID: 12669957

3

Regulatory and study conditions for the determination of bioequivalence of highly variable drugs.

Endrenyi L, Tothfalusi L. Endrenyi L, et al. Among authors: tothfalusi l. J Pharm Pharm Sci. 2009;12(1):138-49. doi: 10.18433/j3zw2c. J Pharm Pharm Sci. 2009. PMID: 19470298 Free article.

4

Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence.

Tothfalusi L, Endrenyi L, Arieta AG. Tothfalusi L, et al. Clin Pharmacokinet. 2009;48(11):725-43. doi: 10.2165/11318040-000000000-00000. Clin Pharmacokinet. 2009. PMID: 19817502 Review.

5

Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products?

Endrenyi L, Tothfalusi L. Endrenyi L, et al. Among authors: tothfalusi l. J Pharm Pharm Sci. 2010 May 10;13(1):107-13. doi: 10.18433/j32g6p. J Pharm Pharm Sci. 2010. PMID: 20456835 Free article.

6

Sample sizes for designing bioequivalence studies for highly variable drugs.

Tothfalusi L, Endrenyi L. Tothfalusi L, et al. J Pharm Pharm Sci. 2012;15(1):73-84. doi: 10.18433/j3z88f. J Pharm Pharm Sci. 2012. PMID: 22365089 Free article.

7

Metrics for the evaluation of bioequivalence of modified-release formulations.

Endrenyi L, Tothfalusi L. Endrenyi L, et al. Among authors: tothfalusi l. AAPS J. 2012 Dec;14(4):813-9. doi: 10.1208/s12248-012-9396-8. Epub 2012 Aug 22. AAPS J. 2012. PMID: 22910857 Free PMC article. Review.

8

Approvable generic carbamazepine formulations may not be bioequivalent in target patient populations.

Tothfalusi L, Endrenyi L. Tothfalusi L, et al. Int J Clin Pharmacol Ther. 2013 Jun;51(6):525-8. doi: 10.5414/CP201845. Int J Clin Pharmacol Ther. 2013. PMID: 23611573

9

Determination of bioequivalence for drugs with narrow therapeutic index: reduction of the regulatory burden.

Endrenyi L, Tothfalusi L. Endrenyi L, et al. Among authors: tothfalusi l. J Pharm Pharm Sci. 2013;16(5):676-82. doi: 10.18433/j31k51. J Pharm Pharm Sci. 2013. PMID: 24393551 Free article.

10

Statistical and regulatory considerations in assessments of interchangeability of biological drug products.

Tóthfalusi L, Endrényi L, Chow SC. Tóthfalusi L, et al. Eur J Health Econ. 2014 May;15 Suppl 1(Suppl 1):S5-11. doi: 10.1007/s10198-014-0589-1. Epub 2014 May 16. Eur J Health Econ. 2014. PMID: 24832831 Free PMC article.

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