Research Topics
| Rashmi R ShahSummaryAffiliation: Veterinary Laboratories Agency Country: UK Publications
| Collaborators |
Detail Information
Publications
Drug-induced prolongation of the QT interval: why the regulatory concern?Rashmi R Shah
Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, UK
Fundam Clin Pharmacol 16:119-24. 2002- The significance of QT interval in drug developmentRashmi R Shah
Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, SW8 5NQ, UK
Br J Clin Pharmacol 54:188-202. 2002 - Mechanistic basis of adverse drug reactions: the perils of inappropriate dose schedulesRashmi R Shah
Medicines and Healthcare products Regulatory Agency MHRA, Market Towers, 1 Nine Elms Lane, Vauxhall, London, SW8 5NQ, UK
Expert Opin Drug Saf 4:103-28. 2005..These advances, together with continued increased awareness and education of prescribers and pharmacists, offer great opportunities for substantially minimising concentration-related ADRs... - Pharmacogenetic aspects of drug-induced torsade de pointes: potential tool for improving clinical drug development and prescribingRashmi R Shah
Medicines and Healthcare products Regulatory Agency, London, United Kingdom
Drug Saf 27:145-72. 2004..However, any potential benefits of pharmacogenetics will be squandered without any reduction in the clinical risk of TdP if physicians do not follow prescribing and monitoring recommendations... - Drug-induced QT interval prolongation: regulatory perspectives and drug developmentRashmi R Shah
Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, SW8 5NQ UK
Ann Med 36:47-52. 2004..Physicians too have an important role by ensuring that they adhere to prescribing information and monitor the patients as recommended... - Drug development and use in the elderly: search for the right dose and dosing regimen (Parts I and II)Rashmi R Shah
Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, UK
Br J Clin Pharmacol 58:452-69. 2004 - Drug-induced QT dispersion: does it predict the risk of torsade de pointes?Rashmi R Shah
Medicines and Healthcare products Regulatory Agency, Vauxhall, London SW8 5NQ, UK
J Electrocardiol 38:10-8. 2005..Although the concept of QT dispersion is the best known and most widely investigated, it has also proved to be the least successful in predicting the risks of drug-induced TdP... - If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?Rashmi R Shah
Former Senior Clinical Assessor, Medicines and Healthcare products Regulatory Agency, London, UK
Pharmacol Ther 119:215-21. 2008..A major challenge is to ensure that such drugs are used appropriately... - Drug-induced QT interval prolongation--regulatory guidance and perspectives on hERG channel studiesRashmi R Shah
Medicines and Healthcare products Regulatory Agency (MHRA, Vauxhall, London, UK
Novartis Found Symp 266:251-80; discussion 280-5. 2005..For adequate risk assessment, hERG channel data should be integrated with all other non-clinical and clinical data; otherwise there is a risk of novel and valuable drugs being rejected from development and/or denied regulatory approval... - Drug-induced QT interval shortening: potential harbinger of proarrhythmia and regulatory perspectivesRashmi R Shah
Medicines and Healthcare products Regulatory Agency, London, UK
Br J Pharmacol 159:58-69. 2010..However, to further substantiate or confirm the safety of these drugs, their approval may well be conditional upon large-scale post-marketing studies with a focus on cardiac safety... - Drugs, QT interval prolongation and ICH E14: the need to get it rightRashmi R Shah
Medicines and Healthcare products Regulatory Agency, London SW8 5NQ, UK
Drug Saf 28:115-25. 2005.... - Refining detection of drug-induced proarrhythmia: QT interval and TRIaDRashmi R Shah
Medicines and Healthcare products Regulatory Agency, London, UK
Heart Rhythm 2:758-72. 2005..Detecting drug-induced augmentation of TRIaD may offer an additional, more sensitive, and accurate indicator of the broader proarrhythmic potential of a drug than may QT interval prolongation alone... - Drug-induced prolongation of the QT interval: regulatory dilemmas and implications for approval and labelling of a new chemical entityRashmi R Shah
Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, UK
Fundam Clin Pharmacol 16:147-56. 2002 - Pharmacogenetics in drug regulation: promise, potential and pitfallsRashmi R Shah
Philos Trans R Soc Lond B Biol Sci 360:1617-38. 2005..In the meantime, prescribing should comply with the information provided while pharmacogenetic research is deservedly supported by all concerned but without unrealistic expectations... - Drugs, QTc interval prolongation and final ICH E14 guideline : an important milestone with challenges aheadRashmi R Shah
Rashmi Shah Pharmaceutical Services, Gerrards Cross, Buckinghamshire, UK
Drug Saf 28:1009-28. 2005.... - Can pharmacogenetics help rescue drugs withdrawn from the market?Rashmi R Shah
Pharmacogenomics 7:889-908. 2006..It is also questionable whether their prescribing will comply with the requirements for pretreatment pharmacogenetic tests to make pharmacogenetic rescue a realistic goal... - Cardiac repolarisation and drug regulation: assessing cardiac safety 10 years after the CPMP guidanceRashmi R Shah
Rashmi Shah Consultancy Ltd, Gerrards Cross, Buckinghamshire, UK
Drug Saf 30:1093-110. 2007....