Lewis DJ - Search Results

1

Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance.

Mueller M, Lewis DJ, Darisi VKK, Horn S. Mueller M, et al. Among authors: lewis dj. Pharmaceut Med. 2020 Dec;34(6):381-386. doi: 10.1007/s40290-020-00364-7. Epub 2020 Dec 8. Pharmaceut Med. 2020. PMID: 33289912 Free PMC article.

2

Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide.

Mueller M, Lewis DJ. Mueller M, et al. Among authors: lewis dj. Ther Innov Regul Sci. 2021 Nov;55(6):1155-1164. doi: 10.1007/s43441-021-00327-3. Epub 2021 Jul 30. Ther Innov Regul Sci. 2021. PMID: 34331266 Review.

3

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

Mueller M, Lewis DJ, Alexe A. Mueller M, et al. Among authors: lewis dj. Br J Clin Pharmacol. 2023 Feb;89(2):470-482. doi: 10.1111/bcp.15573. Epub 2022 Nov 12. Br J Clin Pharmacol. 2023. PMID: 36264908 Free article.

4

Practical Considerations for the Implementation and Monitoring of Risk Minimisation Measures for High-Risk Teratogenic Medicines.

Mueller M, Peakin J, Lewis DJ. Mueller M, et al. Among authors: lewis dj. Pharmaceut Med. 2023 Nov;37(6):439-449. doi: 10.1007/s40290-023-00496-6. Epub 2023 Aug 18. Pharmaceut Med. 2023. PMID: 37594662 Review.

5

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

Jullian S, Jaskiewicz L, Pfannkuche HJ, Parker J, Lalande-Luesink I, Lewis DJ, Close P. Jullian S, et al. Among authors: lewis dj. Pharmacoepidemiol Drug Saf. 2015 Sep;24(9):971-9. doi: 10.1002/pds.3818. Epub 2015 Jul 14. Pharmacoepidemiol Drug Saf. 2015. PMID: 26175055

6

Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities.

Lewis DJ, McCallum JF. Lewis DJ, et al. Ther Innov Regul Sci. 2020 Jul;54(4):888-899. doi: 10.1007/s43441-019-00023-3. Epub 2019 Dec 28. Ther Innov Regul Sci. 2020. PMID: 32557311 Free PMC article. Review.

7

Real-World evidence revelations: The potential of patient support programmes to provide data on medication usage.

Palffy E, Lewis DJ. Palffy E, et al. Among authors: lewis dj. PLoS One. 2024 Feb 8;19(2):e0295226. doi: 10.1371/journal.pone.0295226. eCollection 2024. PLoS One. 2024. PMID: 38330001 Free PMC article.

8

Social media and pharmacovigilance: A review of the opportunities and challenges.

Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M. Sloane R, et al. Br J Clin Pharmacol. 2015 Oct;80(4):910-20. doi: 10.1111/bcp.12717. Epub 2015 Sep 2. Br J Clin Pharmacol. 2015. PMID: 26147850 Free PMC article. Review.

9

Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients.

Rezaallah B, Lewis DJ, Zeilhofer HF, Berg BI. Rezaallah B, et al. Among authors: lewis dj. Ther Innov Regul Sci. 2019 Jan;53(1):110-119. doi: 10.1177/2168479018761638. Epub 2018 Apr 25. Ther Innov Regul Sci. 2019. PMID: 29714593

10

Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR.

van Stekelenborg J, Ellenius J, Maskell S, Bergvall T, Caster O, Dasgupta N, Dietrich J, Gama S, Lewis D, Newbould V, Brosch S, Pierce CE, Powell G, Ptaszyńska-Neophytou A, Wiśniewski AFZ, Tregunno P, Norén GN, Pirmohamed M. van Stekelenborg J, et al. Drug Saf. 2019 Dec;42(12):1393-1407. doi: 10.1007/s40264-019-00858-7. Drug Saf. 2019. PMID: 31446567 Free PMC article.

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