Confirmation of the Cardiac Safety of P218, a new Investigational Medicinal Product for Prevention of Malaria using Intensive ECG Assessments and the Effect of a Meal on QTC to show Assay Sensitivity.
Assessment of C-Peptide Effects on Cardiac Ion Channel Currents. J. Täubel, G. Ferber, Teresa del Bianco, S. Fernandes, Dilshat Djumanov, A. John Camm.
Cardiac Safety of Rupatadine in a Single-Ascending-Dose and Multiple-Ascending-Dose Study in Healthy Japanese Subjects, Using Intensive Electrocardiogram Assessments – Comparison With the Previous White Caucasian Thorough QT Study
Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity. Georg Ferber, PhD, Sara Fernandes, PhD, and Jörg Täubel,MD, FFPM.
Confirmation of the Cardiac Safety of OBE022 in a First in Human Study in Healthy Subjects using Intensive ECG Assessments and the Effect of a Meal on QTc to Show Assay Sensitivity – One of the objectives of this first-in-human study was
The 24 Hour Profile of Moxifloxacin Effect on QTc – A Reflection of Diurnal Variations – This study aims to define the time course of the effect of moxifloxacin on the QT-interval with continuous Holter data in order to better understand
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
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.
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
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
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
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
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
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.
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
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
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
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
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
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
Lamotrigine does not prolong QTc in TQT studies in healthy subjects. Dixon R et al. Br J Clin Pharmacol 2008;66(3):396-404
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
Mason-Likar electrode configuration can confound the recognition of electrode cable interchange. Velislav N et al. J Electrocard, 2010.12.164
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
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
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
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
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
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
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;
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;
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
Assay Sensitivity in QT Assessment. Taubel J et al. Journal for Clinical Studies 2015, 7(6): 60-62
Clinical Trials: A Practical Guide to Design, Analysis, and Reporting Crossover Trials Bioequivalence Trials Source and Control of Bias
The pharmacokinetic interaction between isoniazid/pyrazinamide and TMC207, an investigational antimycobacterial agent. van Heeswijk R et al.
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
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
No clinically relevant effect of TMC125 on the pharmacokinetics of oral contraceptives. Schöller-Gyüre M et al.
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
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
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
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
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
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
Cizolirtine Citrate (E-4018) in the Treatment of Chronic Neuropathic Pain. Shembalkar P et al. Curr Med Res Opin 17(4):262-266, 2001
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
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
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
Early phase clinical trials in the United Kingdom. Jorg Taubel, Richmond Pharmacology Ltd and David Rogers, Medicines Evaluation Unit Ltd, Wythenshawe Hospital.
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
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
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
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
Pharmacokinetics and tolerability of sublingual fentanyl in healthy Japanese and Caucasian volunteers: Phase I, open-label, single-dose study. Lorch U et al.
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
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
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
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,
Efficacy and Safety of MED2005, a Topical Glyceryl Trinitrate Formulation, in the Treatment of Erectile Dysfunction: A Randomized Crossover Study
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
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
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
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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MHRA Phase I Accreditation Certificate (March 2013)
MHRA Phase I Accreditation Certificate (March 2015)
MHRA Phase I Accreditation Certificate (April 2017)
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Richmond Pharmacology’s Research Director Dr Radivoj Arezina has written a piece for the July edition of GMP ReviewRead more ›
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