Richmond Pharmacology

Publications

Richmond Pharmacology is committed to publishing data from clinical trials, however, we will only do so in agreement with our clients or where we own the intellectual property. This page provides access to a selection of publications grouped by the area of research.
Our latest scientific posters and presentations are featured at the end of each section.

 

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Cardiac Safety

 


RPL Publication Assay Sensitivity in QT Assessment. Taubel J et al. Journal for Clinical Studies 2015, 7(6): 60-62

 

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RPL Publication

 

Single Doses up to 800 mg of E-52862 Do Not Prolong the QTc Interval – A Retrospective Validation by Pharmacokinetic- Pharmacodynamic Modelling of Electrocardiography Data Utilising the Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity. Taubel et al. PLOS ONE | DOI:10.1371/journal.pone.0136369. August 20, 2015

 

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RPL Publication Concentration-Effect Modeling Based on Change From Baseline to Assess the Prolonging Effect of Drugs on QTc Together With an Estimate of the Circadian Time Course. Ferber et al.  J Clin Pharmacol, 2014. Submitted for publication 3 April 2014; accepted 12 June 2014. DOI: 10.1002/jcph.347

 

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RPL Publication

 

Analyzing the Relationship of QT Interval and Exposure to Nitazoxanide, a Prospective Candidate for Influenza Antiviral Therapy - A Formal TQT Study. Taubel et al.  J Clin Pharmacol, 2014. Submitted for publication 24 February 2014; accepted 27 March 2014. DOI: 10.1002/jcph.300


 

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RPL Publication Comparison of the effects of levofloxacin on QT/QTc interval assessed in both healthy Japanese and Caucasian subjects. Sugiyama et al. Br J Clin Pharmacol 2011;73(3): 455-459

 

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RPL Publication

 

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, 2012;52:1441-1447

 

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RPL Publication
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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RPL Publication

 

Shortening of the QT Interval After Food Can Be Used to Demonstrate Assay Sensitivity in Thorough QT Studies. Taubel et al. J Clin Pharmacol, 2012;52:1558-1565

 

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RPL Publication Comparison of Six Commonly Used QT Correction Models and Their Parameter Estimation Methods. Wang et al. Journal of Biopharmaceutical Statistics 2012; 22(6):1148-1161

 

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RPL Publication

 

Investigating the Ethnic Differences between the Effect of Moxifloxacin on Cardiac Conduction in Japanese and Caucasians. Dr Jorg Taubel MD FFPM. 5th DIA Cardiac Safety Workshop in Japan, 24 October 2014, Tokyo, Japan 

 

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RPL Publication Mason-Likar electrode configuration can confound the recognition of electrode cable interchange. Velislav N et al. J Electrocard, 2010.12.164

 

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RPL Publication

 

Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects. Taubel J et al. Br J Clin Pharmacol 2014;77 (1), 170-179

 

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RPL Publication

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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RPL Publication

 

Insulin at normal physiological levels does not prolong QTc interval in thorough QT studies performed in healthy volunteers. Taubel et al. Br J Clin Pharmacol 2012;75(2): 392-403

 

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RPL Publication Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QTc interval in healthy volunteers. Taubel et al. Br J Clin Pharmacol 2012;74(2): 296-303

 

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RPL Publication

 

The Power Of Phase I Studies To Detect Clinically Relevant Qtc Prolongation - Results From A Resampling Simulation Study. Ferber et al. The 35th Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 4-6 December 2014, Matsuyama, Japan. DOI: 10.13140/2.1.3423.3921

 

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RPL Publication Investigating the effect of intravenous APD421 (Amilsulpride) and the ethnic differences between Japanese and Caucasians on cardiac conduction. Jorg Taubel · Georg Ferber · Gabriel Fox · Sara Fernandes · Ulrike Lorch · A John Camm. Tokyo, The 36th Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics, https://www.jscpt.jp/eng/index.html

 

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RPL Publication

 

Confirmation of the Cardiac Safety of Rupatadine in a Single Ascending Dose and Multiple Ascending Dose Study in Japanese Healthy Subjects Using Intensive ECG Assessments. Jorg Taubel · Georg Ferber · Inaki Izuierdo. 2015 Annual Meeting, San Francisco, CA; 09/2015

 

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RPL Publication Late Changes After a Euglycaemic Insulin Clamp Can Lead to Significant Increases in QTcF In Healthy Subjects. Taubel et al. 2012 ACCP Annual Meeting, San Diego 23-25 September 2012

 

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RPL Publication

 

Comparison of digital 12-lead ECG and digital 12-lead holter ECG recordings in health male subjects. 112th ASCPT Annual Meeting, March 2-5, 2011, Dallas, TX. Poster Number: PI-08, scheduled on 3/3/2011 from 8:00 AM.


 

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RPL Publication Retrospective Validation using PK-PD modelling of ECG data derived from a Single Ascending Dose study in accordance with the principles of the ICH E14 guideline utilising the effects of a Meal to establish assay sensitivity. 2013 Annual Meeting of the American College of Clinical Pharmacology (ACCP), Bethesda, Maryland, 22-24 September 2013

 

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RPL Publication

 

The Impact of Insulin Levels on QTc Interval in Thorough QT Studies Conducted in Healthy Subjects. Taubel et al. ACCP Annual Meeting, San Diego 23-25 September 2012

 

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RPL Publication Moxifloxacin effect on QTc interval in the fed and fasted states in Thorough QT studies. Jorg Taubel MD FFPM. DIA/FDA Cardiovascular Safety in Drug Development: State-of-the-art Assessments, Washington 18th April 2012

 

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RPL Publication

 

Retrospective analysis of ECG data derived from a four-way cross over study involving a broad spectrum anti-infective agent nitazoxanide. Taubel et al. Pharmacology 2013, London, UK, 17-19 December 2013

 

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RPL Publication

Alternative methods for the confirmation of assay sensitivity in Thorough QT studies. Taubel et al. The 32nd Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 1-3 December 2011, Tokyo, Japan. Program number: 1-P-77


 

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RPL Publication

 

Sex differences on the effect of moxifloxacin - A meta-analysis of five Thorough QT Studies. Taubel et al. The 32nd Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 1-3 December 2011, Tokyo, Japan. Program number:  1-P-79

 

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RPL Publication QT prolongation in healthy Japanese subjects receiving moxifloxacin in Thorough QT studies. Taubel et al. The 32nd Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 1-3 December 2011, Tokyo, Japan. Program number:  1-P-78

 

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Clinical Pharmacology and Adaptive Early Phase Studies

 


RPL Publication Three steps to writing adaptive study protocols in the early phase clinical development of new medicines. Lorch et al. BMC Medical Research Methodology 2014, 14:84 http://www.biomedcentral.com/1471-2288/14/84  

 

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RPL Publication

 

Early phase clinical trials in the United Kingdom. Jorg Taubel, Richmond Pharmacology Ltd and David Rogers, Medicines Evaluation Unit Ltd, Wythenshawe Hospital.
CCRA Yearbook 2014, pp 9-10

 

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RPL Publication Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. Jorup et al. BMC Pulmonary Medicine 2014, 14:52

 

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RPL Publication

 

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 (2012) 68:543-551

 

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RPL Publication 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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RPL Publication

 

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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RPL Publication Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-inhuman study Zhenhua Xu et al. Br J Clin Pharmacol 2011 72(2) / 270-281


 

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RPL Publication

 

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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RPL Publication Ascending single-dose study with ACT-280778, a non-dihydropyridine, dual L- and T-type calcium channel blocker: safety, tolerability, pharmacokinetics, and effect of food in healthy male subjects. Mueller MS et al. Presented at the American Society for Clinical Pharmacology and Therapeutics Annual Meeting, 5-9 March 2013, Indianapolis, Indiana, USA

 

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RPL Publication

 

How adaptive study design can enrich an early phase multiple ascending dose study. Lorch et al.  2014 Annual Meeting of the American College of Clinical Pharmacology (ACCP),Atlanta, GA , 14-16 September 2014

 

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RPL Publication The influence of a low fat diet and hospitalisation on liver function tests in healthy Japanese and Caucasian male volunteers resident in a Phase I unit for up to 34 days. 2013 Annual Meeting of the American College of Clinical Pharmacology (ACCP), Bethesda, Maryland, 22-24 September 2013

 

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RPL Publication

 

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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RPL Publication No clinically relevant effect of TMC125 on the pharmacokinetics of oral contraceptives. Schöller-Gyüre M et al.

 

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RPL Publication

 

Analysis of safety, pharmacokinetic and pharmacodynamic data derived from a single ascending dose Phase 1 study involving a promising non-cytotoxic anti-cancer agent Sulforadex®. Taubel et al. Pharmacology 2013, London, UK, 17-19 December 2013

 

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RPL Publication PET500 A Newly Formulated Tetracaine Product is Effective in Reducing Penile Sensitivity. Taube et al. Thirty-Ninth Annual Meeting American College of Clinical Pharmacology September 12-14, 2010 Baltimore, Maryland. J Clin Pharmacol, September 2010; vol. 50, 9: pp. 1058-1095.

 

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RPL Publication

 

The pharmacokinetic interaction between isoniazid/pyrazinamide and TMC207, an investigational antimycobacterial agent. van Heeswijk R et al.

 

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RPL Publication

Clinical Trials: A Practical Guide to Design, Analysis, and Reporting

Crossover Trials

Bioequivalence Trials

Source and Control of Bias

 

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Japanese Studies

 


RPL Publication Lomitapide single-and multiple-dose exposure in Japanese and Caucasian subjects: results of a Phase 1 pharmacokinetic and pharmacodynamic study. Taubel et al. The 46th Annual Scientific Meeting of the Japan Atherosclerosis Society, Tokyo, Japan, 10-11 July 2014. Abstract 2-P-138/p263

 

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RPL Publication

 

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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RPL Publication Pharmacokinetics, Safety and Tolerability of Rupatadine in Healthy Japanese Volunteers. Jorg Taubel · Eva Santamaria. 2015 Annual Meeting of the American College of Clinical Pharmacology, San Francisco, CA; 09/2015

 

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RPL Publication

 

Gastric Acid Suppression Effect of TAK-438, A Potassium-Competitive Acid  Blocker Following Ascending Multiple Doses in Healthy Subjects. Jenkins et al. 20th United European Gastroenterology Week, Amsterdam, The Netherlands, 20-24 Oct 2012. GUT 2012: 61 S3: A201

 

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RPL Publication

Pharmacokinetics and tolerability of sublingual fentanyl in healthy Japanese and Caucasian volunteers: Phase I, open-label, single-dose study. Lorch U et al.

 

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RPL Publication

 

Gastric Acid Suppression Effect of TAK-438, A Potassium-Competitive Acid  Blocker Following Ascending Single Doses in Healthy Subjects. Sakurai et al. 20th United European Gastroenterology Week, Amsterdam, The Netherlands, 20-24 Oct 2012. GUT 2012: 61 S3: A201

 

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RPL Publication

Similar Rivastigmine Pharmacokinetics and Pharmacodynamics in Japanese and White Healthy Participants Following the Application of Novel Rivastigmine Patch. Lefèvre et al. J Clin Pharmacol April 2009 49: 430-443

 

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RPL Publication

 

The safety, tolerability and pharmacokinetics of AZD5069, a novel CXCR2 antagonist,in healthy Japanese volunteers. Lorch et al. ERS 2012, September 1-5, Vienna, Austria

 

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Patient Studies

 


RPL Publication Pharmacodynamic Consequences of Administration of VLA-4 Antagonist CDP323 to Multiple Sclerosis Subjects: A Randomized, Double-Blind Phase 1/2 Study. Wolf et al. PLOS ONE Journal. March 2013 | Volume 8 | Issue 3 | e58438

 

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RPL Publication

 

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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RPL Publication 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. Single 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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RPL Publication

 

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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Corporate Information

 


RPL Publication MHRA Phase I Accreditation Certificate (April 2017)

 

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RPL Publication

 

MHRA Phase I Accreditation Certificate (March 2015)

 

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RPL Publication MHRA Phase I Accreditation Certificate (March 2013)

 

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RPL Publication

 

Richmond Pharmacology Limited
Financial Statements for the Year Ended
31 December 2013. Company Registration Number 04269261

Financial Statements for prior years are available on request - Click here for contact and enquiries

 

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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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