McDougall S - Search Results

1

The use of surrogate matrices in bioanalytical preclinical safety testing using chromatographic methods: a recommendation from the European Bioanalysis forum.

Goodwin L, McDougall S, Gnoth MJ, Mascher D, Ferrari L, Wheller R, Hawthorne H, Jansat JM, Faber J, Huber P, Greco A, Eggers LF, Sury M, Karlsson JJ, Sporring SH, Globig S, de Merbel NV, Timmerman P. Goodwin L, et al. Among authors: mcdougall s. Bioanalysis. 2024 Oct 23:1-4. doi: 10.1080/17576180.2024.2416360. Online ahead of print. Bioanalysis. 2024. PMID: 39440608

2

Data integrity in regulated bioanalysis: a summary from the European Bioanalysis Forum Workshop in collaboration with the MHRA.

Arfvidsson C, Bedaf DV, Doig M, Globig S, Knutsson M, Lewis M, McDougall S, Michi M, Mokrzycki N, Timmerman P. Arfvidsson C, et al. Among authors: mcdougall s. Bioanalysis. 2019 Jun;11(13):1227-1231. doi: 10.4155/bio-2019-0139. Bioanalysis. 2019. PMID: 31452404

3

Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC-MS from the European Bioanalysis Forum.

Arfvidsson C, Bedaf DV, Globig S, Knutsson M, Lewis M, McDougall S, Michi M, Timmerman P. Arfvidsson C, et al. Among authors: mcdougall s. Bioanalysis. 2020 Jul;12(14):1033-1038. doi: 10.4155/bio-2020-0156. Epub 2020 Jul 24. Bioanalysis. 2020. PMID: 32706625

4

Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.

Timmerman P, Barfield M, Portabella EB, Calogero S, Cowan K, Faber J, Ferrari L, Golob M, Goodman J, Goodwin L, Gnoth MJ, Hughes R, Ivanova T, Jordan G, Laurén A, Maux D, McDougall S, Milushewa P, Nelson R, Pynaert G, Sklodowski K, Sleigh R, Struwe P, Verhaeghe T, Wheller R, White S, Zeiser K. Timmerman P, et al. Among authors: mcdougall s. Bioanalysis. 2024 Mar;16(5):259-270. doi: 10.4155/bio-2024-0013. Epub 2024 Feb 5. Bioanalysis. 2024. PMID: 38315622

5

Tiered approach into practice: scientific validation for chromatography-based assays in early development - a recommendation from the European Bioanalysis Forum.

Timmerman P, White S, McDougall S, Kall MA, Smeraglia J, Fjording MS, Knutsson M. Timmerman P, et al. Among authors: mcdougall s. Bioanalysis. 2015 Sep;7(18):2387-2398. doi: 10.4155/bio.15.168. Epub 2015 Sep 10. Bioanalysis. 2015. PMID: 26354595

6

Best practices for metabolite quantification in drug development: updated recommendation from the European Bioanalysis Forum.

Timmerman P, Blech S, White S, Green M, Delatour C, McDougall S, Mannens G, Smeraglia J, Williams S, Young G. Timmerman P, et al. Among authors: mcdougall s. Bioanalysis. 2016 Jun;8(12):1297-305. doi: 10.4155/bio-2016-0103. Epub 2016 May 24. Bioanalysis. 2016. PMID: 27217058

7

Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline.

Timmerman P, Barfield M, Cowan K, Ferrari L, Golob M, Goodman J, Kall M, Laurén A, Love I, McDougall S, Nelson R, Pynaert G, Staack RF, Verhaeghe T, White S. Timmerman P, et al. Among authors: mcdougall s. Bioanalysis. 2022 Nov;14(22):1407-1411. doi: 10.4155/bio-2022-0229. Epub 2023 Jan 27. Bioanalysis. 2022. PMID: 36705021

8

The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum.

Timmerman P, Ivanova T, Arfvidsson C, Barfield M, Bove F, Brown LD, Goodman J, McDougall S, Monk L, White S. Timmerman P, et al. Among authors: mcdougall s. Bioanalysis. 2024;16(13):635-639. doi: 10.4155/bio-2024-0055. Epub 2024 Mar 26. Bioanalysis. 2024. PMID: 38530219

9

Conference report: AAPS and US FDA Crystal City V meeting on Quantitative Bioanalytical Method Validation and Implementation: feedback from the EBF.

Smeraglia J, McDougall S, Elsby K, Companjen A, White S, Golob M, Brudny-Kloeppel M, Amsterdam Pv, Timmerman P. Smeraglia J, et al. Among authors: mcdougall s. Bioanalysis. 2014 Mar;6(6):729-32. doi: 10.4155/bio.14.17. Bioanalysis. 2014. PMID: 24702107

10

Feedback from the European Bioanalysis Forum Workshop: taking tiered approach to the next level.

Timmerman P, White S, Knutsson M, Kall MA, Fjording MS, Smeraglia J, McDougall S. Timmerman P, et al. Among authors: mcdougall s. Bioanalysis. 2014;6(19):2593-8. doi: 10.4155/bio.14.224. Bioanalysis. 2014. PMID: 25411702 No abstract available.

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