Schuirmann DJ - Search Results

1

Novel bioequivalence approach for narrow therapeutic index drugs.

Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Yu LX, et al. Among authors: schuirmann dj. Clin Pharmacol Ther. 2015 Mar;97(3):286-91. doi: 10.1002/cpt.28. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669762

2

Bioequivalence approaches for highly variable drugs and drug products.

Haidar SH, Davit B, Chen ML, Conner D, Lee L, Li QH, Lionberger R, Makhlouf F, Patel D, Schuirmann DJ, Yu LX. Haidar SH, et al. Among authors: schuirmann dj. Pharm Res. 2008 Jan;25(1):237-41. doi: 10.1007/s11095-007-9434-x. Epub 2007 Sep 22. Pharm Res. 2008. PMID: 17891552 Review.

3

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.

Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, Lionberger RA, Makhlouf FT, Nwakama PE, Patel DT, Schuirmann DJ, Yu LX. Davit BM, et al. Among authors: schuirmann dj. AAPS J. 2012 Dec;14(4):915-24. doi: 10.1208/s12248-012-9406-x. Epub 2012 Sep 13. AAPS J. 2012. PMID: 22972221 Free PMC article. Review.

4

A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, Yu LX, Lionberger R. Jiang W, et al. Among authors: schuirmann dj. AAPS J. 2015 Jul;17(4):891-901. doi: 10.1208/s12248-015-9753-5. Epub 2015 Apr 4. AAPS J. 2015. PMID: 25840883 Free PMC article.

5

Pharmacokinetic analysis of bioequivalence trials: implications for sex-related issues in clinical pharmacology and biopharmaceutics.

Chen ML, Lee SC, Ng MJ, Schuirmann DJ, Lesko LJ, Williams RL. Chen ML, et al. Among authors: schuirmann dj. Clin Pharmacol Ther. 2000 Nov;68(5):510-21. doi: 10.1067/mcp.2000.111184. Clin Pharmacol Ther. 2000. PMID: 11103754

6

Evaluation of a scaling approach for the bioequivalence of highly variable drugs.

Haidar SH, Makhlouf F, Schuirmann DJ, Hyslop T, Davit B, Conner D, Yu LX. Haidar SH, et al. Among authors: schuirmann dj. AAPS J. 2008 Sep;10(3):450-4. doi: 10.1208/s12248-008-9053-4. Epub 2008 Aug 26. AAPS J. 2008. PMID: 18726698 Free PMC article.

7

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, Yu LX, Lionberger R. Jiang W, et al. Among authors: schuirmann dj. AAPS J. 2015 Nov;17(6):1519. doi: 10.1208/s12248-015-9786-9. AAPS J. 2015. PMID: 25975618 Free PMC article. No abstract available.

8

Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group.

Hauck WW, Chen ML, Hyslop T, Patnaik R, Schuirmann D, Williams R. Hauck WW, et al. Int J Clin Pharmacol Ther. 1996 Dec;34(12):535-41. Int J Clin Pharmacol Ther. 1996. PMID: 8996848

9

An individual bioequivalence criterion: regulatory considerations.

Chen ML, Patnaik R, Hauck WW, Schuirmann DJ, Hyslop T, Williams R. Chen ML, et al. Among authors: schuirmann dj. Stat Med. 2000 Oct 30;19(20):2821-42. doi: 10.1002/1097-0258(20001030)19:20<2821::aid-sim548>3.0.co;2-l. Stat Med. 2000. PMID: 11033578

10

On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence.

Schuirmann DJ, Grosser S, Chattopadhyay S, Chow SC. Schuirmann DJ, et al. Clin Pharmacol Ther. 2019 Feb;105(2):304-306. doi: 10.1002/cpt.1291. Epub 2019 Jan 21. Clin Pharmacol Ther. 2019. PMID: 30666636 No abstract available.

Save citations to file

Email citations

Send citations to clipboard

Add to Collections

Add to My Bibliography

Create a file for external citation management software

Your saved search

Your RSS Feed

My NCBI Filters

Text availability

Article attribute

Article type

Publication date

21 results

Search Page