Leblond D - Search Results

1

DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.

Hoffelder T, Leblond D, Van Alstine L, Diaz DA, Suarez-Sharp S, Witkowski K, Altan S, Reynolds J, Bergeron Z, Lief K, Zheng Y, Abend A. Hoffelder T, et al. Among authors: leblond d. AAPS J. 2022 Apr 6;24(3):54. doi: 10.1208/s12248-022-00697-y. AAPS J. 2022. PMID: 35386051

2

Dissolution curve comparisons through the F(2) parameter, a Bayesian extension of the f(2) statistic.

Novick S, Shen Y, Yang H, Peterson J, LeBlond D, Altan S. Novick S, et al. Among authors: leblond d. J Biopharm Stat. 2015;25(2):351-71. doi: 10.1080/10543406.2014.971175. J Biopharm Stat. 2015. PMID: 25357203

3

Evaluating Current Practices in Shelf Life Estimation.

Capen R, Christopher D, Forenzo P, Huynh-Ba K, LeBlond D, Liu O, O'Neill J, Patterson N, Quinlan M, Rajagopalan R, Schwenke J, Stroup W. Capen R, et al. Among authors: leblond d. AAPS PharmSciTech. 2018 Feb;19(2):668-680. doi: 10.1208/s12249-017-0880-4. Epub 2017 Sep 25. AAPS PharmSciTech. 2018. PMID: 28948584

4

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary Report.

Suarez-Sharp S, Abend A, Hoffelder T, Leblond D, Delvadia P, Kovacs E, Diaz DA. Suarez-Sharp S, et al. Among authors: leblond d. AAPS J. 2020 May 19;22(4):74. doi: 10.1208/s12248-020-00458-9. AAPS J. 2020. PMID: 32430592 Review.

5

Stability analysis using mixed models: A critique of tolerance interval methods and a probabilistic solution.

Altan S, Faya P, Rauk AP, LeBlond D, Seaman JW Jr, Banton D. Altan S, et al. Among authors: leblond d. Pharm Stat. 2023 Sep-Oct;22(5):784-796. doi: 10.1002/pst.2305. Epub 2023 May 10. Pharm Stat. 2023. PMID: 37164770

6

Bayesian statistical approaches to drug product variability assessment and release.

Cai Q, Mockus L, LeBlond D, Sun X, Wei H, Shah HS, Chaturvedi K, Sardhara R, Nahar K, Khalil R, Sharma A, Rutesh D, Joglekar G, Reklaitis G, Morris K. Cai Q, et al. Among authors: leblond d. Int J Pharm. 2022 Aug 25;624:122037. doi: 10.1016/j.ijpharm.2022.122037. Epub 2022 Jul 21. Int J Pharm. 2022. PMID: 35870665 Review.

7

Testing assay linearity over a pre-specified range.

Yang H, Novick SJ, LeBlond D. Yang H, et al. Among authors: leblond d. J Biopharm Stat. 2015;25(2):339-50. doi: 10.1080/10543406.2014.972513. J Biopharm Stat. 2015. PMID: 25356663

8

Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products.

Montes RO, Burdick RK, Leblond DJ. Montes RO, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):39-59. doi: 10.5731/pdajpst.2018.008839. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361286

9

A QbD case study: Bayesian prediction of lyophilization cycle parameters.

Mockus L, LeBlond D, Basu PK, Shah RB, Khan MA. Mockus L, et al. Among authors: leblond d. AAPS PharmSciTech. 2011 Mar;12(1):442-8. doi: 10.1208/s12249-011-9598-x. Epub 2011 Mar 4. AAPS PharmSciTech. 2011. PMID: 21373766 Free PMC article.

10

Risk-Based Approach to Lot Release.

Mockus L, Reklaitis G, Morris K, LeBlond D. Mockus L, et al. Among authors: leblond d. J Pharm Sci. 2020 Feb;109(2):1035-1042. doi: 10.1016/j.xphs.2019.10.011. Epub 2019 Oct 11. J Pharm Sci. 2020. PMID: 31610180

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 Custom Filters

Publication date

Text availability

Article attribute

Article type

Article Language

Species

Sex

Age

Other

46 results

Search Page

Filters