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Eric Woolf

Explore the profile of Eric Woolf including associated specialties, affiliations and a list of published articles. Areas
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Articles 41
Citations 220
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Recent Articles
1.
Vazvaei-Smith F, Wickremsinhe E, Woolf E, Yu C
AAPS J . 2024 Sep; 26(5):103. PMID: 39266900
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted Guideline M10 entitled "Bioanalytical Method Validation and Study Sample Analysis" in May 2022. In October...
2.
Fang W, Chavez-Eng C, Lutz R, Li H, Schlegel J, Roadcap B, et al.
Bioanalysis . 2024 Aug; 16(16):863-871. PMID: 39119687
Cholesteryl ester transfer protein (CETP) inhibitor is a target for both lowering low-density lipoproteins and raising high-density lipoproteins. Anacetrapib was the lead compound in our cholesteryl ester transfer protein inhibitor...
3.
Davis S, Mitra-Kaushik S, Woolf E, Evens J, Dawes M, Kentner J, et al.
Bioanalysis . 2023 Dec; 15(24):1461-1468. PMID: 38044848
While using the cloud environment for various functions has become commonplace, relatively little attention has been given to considerations for the use of third-party cloud services for regulated bioanalytical workflow...
4.
Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, et al.
Bioanalysis . 2023 Aug; 15(16):955-1016. PMID: 37650500
The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory...
5.
Kaur S, Alley S, Szapacs M, Wilson A, Ciccimaro E, Su D, et al.
Bioanalysis . 2022 May; 14(9):505-580. PMID: 35578993
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to...
6.
Anderson M, Dockendorf M, McIntosh I, Xie I, Breidinger S, Meng D, et al.
AAPS J . 2022 Apr; 24(3):52. PMID: 35384529
In-clinic dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer's disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential alternative to...
7.
Dockendorf M, Jaworowicz D, Humphrey R, Anderson M, Breidinger S, Ma L, et al.
AAPS J . 2022 Apr; 24(3):53. PMID: 35384522
In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer's disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential alternative...
8.
Davis S, Usansky J, Mitra-Kaushik S, Kellie J, Honrine K, Woolf E, et al.
Bioanalysis . 2021 Sep; 13(17):1313-1321. PMID: 34515519
Challenges for data storage during drug development have become increasingly complex as the pharmaceutical industry expands in an environment that requires on-demand availability of data and resources for users across...
9.
Keller S, Quiroz J, Christopher D, Wickremsinhe E, Geng W, Hawthorne G, et al.
Bioanalysis . 2021 Feb; 13(3):135-145. PMID: 33538614
The use of quality control (QC) samples in bioanalysis is well established and consistent with regulatory guidance. However, a systematic evaluation of whether QC samples serve the intended purpose of...
10.
Neubert H, Alley S, Lee A, Jian W, Buonarati M, Edmison A, et al.
Bioanalysis . 2021 Jan; 13(4):203-238. PMID: 33470871
The 14 edition of the Workshop on Recent Issues in Bioanalysis (14 WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies,...