Transaminase elevation on placebo during Phase I trials: prevalence and significance

Author:

Rosenzweig 1,Miget 1,Brohier 1

Affiliation:

1. Department of Clinical Pharmacology, Synthélabo Recherche, 31 avenue Paul Vaillant‐Couturier, 92225 Bagneux Cedex, France

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference11 articles.

1. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspective

2. Spriet‐PourraC&AuricheMDrug withdrawal from sale: an analysis of the phenomenon and its implications. Richmond Surrey United Kingdom:Scrip Reports/PJB Publications 1988

3. LymleyCClinical toxicity: could it have been predicted? Pre‐marketing experience. InAnimal Toxicity Studies: Their Relevance for Man eds Lumley CE Walker SR Lancaster UK. Quay 1990:4956

4. Elevated Serum Transaminase Values in Volunteers after Administration of Placebo in a Phase I Study.

5. Elevation of Liver Enzymes in Multiple Dose Trials During Placebo Treatment: Are They Predictable?

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