» Articles » PMID: 29451320

Commentary on the EMA Guideline on Strategies to Identify and Mitigate Risks for First-in-human and Early Clinical Trials with Investigational Medicinal Products

Overview
Specialty Pharmacology
Date 2018 Feb 17
PMID 29451320
Citations 92
Authors
Affiliations
Soon will be listed here.
Citing Articles

SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.

Ursino M, Villacampa G, Rekowski J, Dimairo M, Solovyeva O, Ashby D EClinicalMedicine. 2025; 79:102988.

PMID: 39877554 PMC: 11773215. DOI: 10.1016/j.eclinm.2024.102988.


CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.

Rekowski J, Guo C, Solovyeva O, Dimairo M, Rouhifard M, Patel D EClinicalMedicine. 2025; 79:102987.

PMID: 39877553 PMC: 11773258. DOI: 10.1016/j.eclinm.2024.102987.


Synthesizing regulatory guidance for demonstrating preclinical efficacy and translating promising cell therapies to early phase clinical trials: a scoping review.

Jeffers M, Xi C, Bapuji R, Wotherspoon H, Kimmelman J, Bedford P BMC Med. 2024; 22(1):487.

PMID: 39443960 PMC: 11515533. DOI: 10.1186/s12916-024-03690-8.


ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells.

Carretero-Iglesia L, Hall O, Berret J, Pais D, Estoppey C, Chimen M Nat Cancer. 2024; 5(10):1494-1514.

PMID: 39261676 PMC: 11505469. DOI: 10.1038/s43018-024-00821-1.


Phase 0 trials/ Intra-Target-Microdosing (ITM) and the lung: a review.

Quinn T, Bruce A, Burt T, Dhaliwal K BMC Pulm Med. 2024; 24(1):425.

PMID: 39210357 PMC: 11363577. DOI: 10.1186/s12890-024-03193-5.


References
1.
van Gerven J, Cohen A . Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects. Br J Clin Pharmacol. 2018; 84(7):1457-1466. PMC: 6005609. DOI: 10.1111/bcp.13529. View

2.
van Gerven J, Bonelli M . Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. Br J Clin Pharmacol. 2018; 84(7):1401-1409. PMC: 6005602. DOI: 10.1111/bcp.13550. View

3.
Kerbrat A, Ferre J, Fillatre P, Ronziere T, Vannier S, Carsin-Nicol B . Acute Neurologic Disorder from an Inhibitor of Fatty Acid Amide Hydrolase. N Engl J Med. 2016; 375(18):1717-1725. DOI: 10.1056/NEJMoa1604221. View

4.
Kenter M, Cohen A . Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet. 2006; 368(9544):1387-91. DOI: 10.1016/S0140-6736(06)69562-7. View

5.
Morgan P, van der Graaf P, Arrowsmith J, Feltner D, Drummond K, Wegner C . Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discov Today. 2012; 17(9-10):419-24. DOI: 10.1016/j.drudis.2011.12.020. View