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Bloem LT , Karomi M , Hoekman J , van der Elst ME , Leufkens HGM , Klungel OH , Mantel-Teeuwisse AK . Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks. Expert Opin Drug Saf 2021;:1-10. [PMID: 34263667 DOI: 10.1080/14740338.2021.1952981 ] [ Reference Citation Analysis ]
2
Minnema LA , Giezen TJ , Gardarsdottir H , Egberts TCG , Leufkens HGM , Mantel-Teeuwisse AK . Post-marketing dosing changes in the label of biologicals. Br J Clin Pharmacol 2019;85 :715-21. [PMID: 30593087 DOI: 10.1111/bcp.13843 ] [ Cited by in Crossref: 2] [ Cited by in F6Publishing: 3 ] [ Article Influence: 0.7 ] [ Reference Citation Analysis ]
3
Passot C , Sberro-Soussan R , Bertrand D , Caillard S , Schvartz B , Domenger C , Contin-Bordes C , Paintaud G , Halimi JM , Ternant D , Gatault P . Feasibility and safety of tailored dosing schedule for eculizumab based on therapeutic drug monitoring: Lessons from a prospective multicentric study. Br J Clin Pharmacol 2021;87 :2236-46. [PMID: 33118186 DOI: 10.1111/bcp.14627 ] [ Cited by in Crossref: 1] [ Article Influence: 0.5 ] [ Reference Citation Analysis ]
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