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Monitoring liver safety in drug development: the GSK experience.

Publication ,  Journal Article
Hunt, CM; Papay, JI; Edwards, RI; Theodore, D; Alpers, DH; Dollery, C; Debruin, TW; Adkison, KK; Stirnadel, HA; Gibbs, TG
Published in: Regul Toxicol Pharmacol
November 2007

To promptly identify and evaluate liver safety events, an evidence-based liver safety system was created for global Phase I-III clinical trials. The goals of this system included improving clinical trial subject safety, expanding information on liver safety events, and improving data quality across studies by establishing and communicating: Two different algorithms for liver stopping criteria were developed. The most stringent criteria were selected for healthy volunteers in Phase I studies, where no treatment benefit is anticipated and clinical safety data are limited. With an interest in assessing potential liver "tolerance" or adaptation with accruing safety information, slightly higher liver chemistry thresholds were set for Phase II-III studies. This paper will describe the importance of liver safety in drug development, laboratory tests used to monitor liver safety, the rationale for selected liver chemistry subject stopping criteria, and implementation of this safety system.

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Published In

Regul Toxicol Pharmacol

DOI

ISSN

0273-2300

Publication Date

November 2007

Volume

49

Issue

2

Start / End Page

90 / 100

Location

Netherlands

Related Subject Headings

  • Withholding Treatment
  • Toxicology
  • Liver Function Tests
  • Liver
  • Humans
  • Evidence-Based Medicine
  • Endpoint Determination
  • Drug-Related Side Effects and Adverse Reactions
  • Drug Monitoring
  • Clinical Trials as Topic
 

Citation

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Hunt, C. M., Papay, J. I., Edwards, R. I., Theodore, D., Alpers, D. H., Dollery, C., … Gibbs, T. G. (2007). Monitoring liver safety in drug development: the GSK experience. Regul Toxicol Pharmacol, 49(2), 90–100. https://doi.org/10.1016/j.yrtph.2007.06.002
Hunt, Christine M., Julie I. Papay, Rita I. Edwards, Dickens Theodore, David H. Alpers, Colin Dollery, Tjerk W. Debruin, Kimberly K. Adkison, Heide A. Stirnadel, and Trevor G. Gibbs. “Monitoring liver safety in drug development: the GSK experience.Regul Toxicol Pharmacol 49, no. 2 (November 2007): 90–100. https://doi.org/10.1016/j.yrtph.2007.06.002.
Hunt CM, Papay JI, Edwards RI, Theodore D, Alpers DH, Dollery C, et al. Monitoring liver safety in drug development: the GSK experience. Regul Toxicol Pharmacol. 2007 Nov;49(2):90–100.
Hunt, Christine M., et al. “Monitoring liver safety in drug development: the GSK experience.Regul Toxicol Pharmacol, vol. 49, no. 2, Nov. 2007, pp. 90–100. Pubmed, doi:10.1016/j.yrtph.2007.06.002.
Hunt CM, Papay JI, Edwards RI, Theodore D, Alpers DH, Dollery C, Debruin TW, Adkison KK, Stirnadel HA, Gibbs TG. Monitoring liver safety in drug development: the GSK experience. Regul Toxicol Pharmacol. 2007 Nov;49(2):90–100.
Journal cover image

Published In

Regul Toxicol Pharmacol

DOI

ISSN

0273-2300

Publication Date

November 2007

Volume

49

Issue

2

Start / End Page

90 / 100

Location

Netherlands

Related Subject Headings

  • Withholding Treatment
  • Toxicology
  • Liver Function Tests
  • Liver
  • Humans
  • Evidence-Based Medicine
  • Endpoint Determination
  • Drug-Related Side Effects and Adverse Reactions
  • Drug Monitoring
  • Clinical Trials as Topic