Publications
Regular publication of clinical trial data is essential for all involved in research and drug development.
Irrespective of the outcome of clinical studies, all data can be useful. Richmond Pharmacology is
committed to publishing data from clinical trials. This page will provide access to a variety of publications,
from abstracts, presentations, posters, book chapters and articles, members of the Richmond Pharmacology
team have been involved in. If you would you like us to send you the full article please click here.
Featured Publications
| The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Lorch et al. Eur J Clin Pharmacol published online 25 November 2011. DOI 10.1007/s00228-011-1176-3
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Shortening of the QT Interval After Food Can Be Used to Demonstrate Assay Sensitivity in Thorough QT Studies. Taubel et al. J Clin Pharmacol published online 8 November 2011. DOI: 10.1177/0091270011419851
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Bupivacaine Extended Release Liposome Injection Does Not Prolong QTc Interval in a Thorough QT/QTc Study in Healthy Volunteers. Naseem et al. J Clin Pharmacol published online 4 November 2011. DOI: 10.1177/0091270011419853
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Benefits of a Single Versus Multicenter Approach in Early-Phase Patient Studies; A Case Study of Multiple Sclerosis Patients. Berelowitz et al. The Monitor Page 21-25. October 2011
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Effect of Levofloxacin on QT/QTc Assessed in Healthy Japanese and Caucasian Subjects. Jorg Taubel MD FFPM. 2nd DIA Cardiac Safety Workshop in Japan, Tokyo 5th September 2011.
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Comparison of the Effects of Levofloxacin on QT/QTc interval Assessed in both Healthy Japanese and Caucasian Subjects.Taubel et al. This is an Accepted Article that has been peer-reviewed and approved for publication in the British Journal of Clinical Pharmacology,
but has yet to undergo copy-editing and proof correction. Please cite
this article as an “Accepted Article”; doi:
10.1111/1365-2125.2011.04110.x
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Food can serve as a non‐pharmacological control in thorough cardiac safety studies. Jorg Taubel MD FFPM. DIA/FDA Cardiovascular Safety in Drug Development: State-of-the-art Assessments, Washington 14th April 2011
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SKY0402 (bupivacaine) does not prolong QTc interval in a
thorough QT/QTc study in healthy volunteers. Harada T et al. Jpn J Clin
Pharmacol Ther 2009;40 supplement (English & Japanese versions)
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An open-label, parallel-group, repeat-dose study to investigate the effects of end-stage renal disease and haemodialysis on the pharmacokinetics of ropinirole. Tompson et al. 13th International Congress of Parkinson’s Disease and Movement Disorders, Paris, France, June 7–11, 2009
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Levofloxacin can be used as a positive control in QT/QTc studies in healthy subjects (paper). Taubel J et al. Br J Clin Pharmacol 2010;69(4):391-400
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Effect of oseltamivir treatment on anticoagulation: a cross-over study in warfarinized patients. Davies B et al. Br J Clin Pharmacol 2010;70(6):834-843. Singe centre drug interaction study in 20 patient volunteers on regular warfarin. The study was performed at Richmond Pharmacology, a further publication describing the recruitment efforts involved has been submitted.
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Rule Britannia – the advantages of conducting first-time-in-human (FTIH) studies in the UK compared to other European markets. Taubel J, Berelowitz K, Lorch U. International Clinical Trials P16+ February 2011
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A phase I, randomised single center, open-label parallel group trial to compare the pharmacokinetics of NOMAC between healthy female adolescents (aged 14-17 years) and healthy female adults (aged 18-50 years) after single dose administration of NOMAC-E2 tablets. This study included a total of 30 subjects (15 subjects, aged 14-17 subjects, aged 18-50 years), lasting approximately 7 weeks and was the first ever paediatric study in healthy adolescents to be conducted in Europe.
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Lamotrigine does not prolong QTc in TQT studies in healthy subjects. Dixon R et al. Br J Clin Pharmacol 2008;66(3):396-404
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TQT Studies:
Their Impact on Drug Development and the Key Elements of a Successful
TQT Study. Naseem A et al. Br J Clin Pharmacol 2009;68(S1):6-59.
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Alternative methods for the confirmation of assay sensitivity in thorough QT studies. Taubel et al. ACCP 40th Annual Meeting, Chicago, 11-13 September 2011.
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Early Phase Japanese Bridging Studies; Their Global Significance and What to Look for when Selecting a Suitable Contract Research Organisation to Conduct these Studies. Berelowitz K et al. International Pharmaceutical Industry; Volume 3, Issue 1: Page
64-72
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Cizolirtine Citrate (E-4018) in the Treatment of Chronic Neuropathic Pain. Shembalkar P et al. Curr Med Res Opin 17(4):262-266, 2001
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Effects on 24-Hour Intragastric pH: A Comparison of Lansoprazole Administered Nasogastrically in Apple Juice and Pantoprazole Administered Intravenously. Freston J et al. The American Journal of Gastroenterology Vol. 96, No. 7, 2001
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Additional Publications
Book Chapters
For an oppurtunity to receive the book for free click here
Each month Richmond Pharmacology will give away two copies of the publication, Clinical Trials A Practical Guide to Design, Analysis, and Reporting. Simply fill out the form "Challenge Richmond Pharmacology" and express your interest in receiving a copy from the drop down list and you will be entered into the draw to receive your free copy of this publication.
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