Endrenyi L - Search Results

1

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

2

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

3

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

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

5

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.

6

On the interchangeability of biologic drug products.

Endrenyi L, Chang C, Chow SC, Tothfalusi L. Endrenyi L, et al. Stat Med. 2013 Feb 10;32(3):434-41. doi: 10.1002/sim.5569. Epub 2012 Aug 22. Stat Med. 2013. PMID: 22911936

7

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

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

8

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.

9

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

10

Bioequivalence for highly variable drugs: regulatory agreements, disagreements, and harmonization.

Endrenyi L, Tothfalusi L. Endrenyi L, et al. J Pharmacokinet Pharmacodyn. 2019 Apr;46(2):117-126. doi: 10.1007/s10928-019-09623-w. Epub 2019 Feb 23. J Pharmacokinet Pharmacodyn. 2019. PMID: 30798390 Review.

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