Endrényi L - Search Results

1

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

Tóthfalusi L, Endrényi L, Chow SC. Tóthfalusi L, et al. Among authors: endrenyi l. 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.

2

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

Tothfalusi L, Endrenyi L. Tothfalusi L, et al. Among authors: endrenyi l. 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.

3

Algorithms for evaluating reference scaled average bioequivalence: power, bias, and consumer risk.

Tothfalusi L, Endrenyi L. Tothfalusi L, et al. Among authors: endrenyi l. Stat Med. 2017 Nov 30;36(27):4378-4390. doi: 10.1002/sim.7440. Epub 2017 Aug 29. Stat Med. 2017. PMID: 28850696

4

The Two Main Goals of Bioequivalence Studies.

Endrenyi L, Blume HH, Tothfalusi L. Endrenyi L, et al. AAPS J. 2017 Jul;19(4):885-890. doi: 10.1208/s12248-017-0048-x. Epub 2017 Feb 2. AAPS J. 2017. PMID: 28155028

5

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

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

6

Sample sizes for designing bioequivalence studies for highly variable drugs.

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

7

Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets.

Tothfalusi L, Speidl S, Endrenyi L. Tothfalusi L, et al. Among authors: endrenyi l. Br J Clin Pharmacol. 2008 Jan;65(1):110-22. doi: 10.1111/j.1365-2125.2007.02984.x. Epub 2007 Aug 15. Br J Clin Pharmacol. 2008. PMID: 17711537 Free PMC article. Clinical Trial.

8

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

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

9

The need for additional metrics to assess therapeutic equivalence of some multiphasic modified-release products.

Kondra PM, Endrenyi L, Tothfalusi L. Kondra PM, et al. Among authors: endrenyi l. Clin Ther. 2011 Sep;33(9):1214-9. doi: 10.1016/j.clinthera.2011.07.014. Epub 2011 Aug 17. Clin Ther. 2011. PMID: 21849209

10

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

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

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