Rashmi R Shah

Summary

Country: UK

Publications

  1. pmc ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 75:959-65. 2013
  2. doi request reprint Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, 8 Birchdale, Gerrards Cross, Buckinghamshire, SL9 7JA, UK
    Drug Saf 36:491-503. 2013
  3. doi request reprint Cardiovascular safety of tyrosine kinase inhibitors: with a special focus on cardiac repolarisation (QT interval)
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, 8 Birchdale, Gerrards Cross, Buckinghamshire SL9 7JA, UK
    Drug Saf 36:295-316. 2013
  4. pmc Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 75:347-58. 2013
  5. pmc Personalized medicine: is it a pharmacogenetic mirage?
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 74:698-721. 2012
  6. pmc Drug-induced QT interval shortening: potential harbinger of proarrhythmia and regulatory perspectives
    Rashmi R Shah
    Medicines and Healthcare products Regulatory Agency, London, UK
    Br J Pharmacol 159:58-69. 2010
  7. ncbi request reprint Cardiac repolarisation and drug regulation: assessing cardiac safety 10 years after the CPMP guidance
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, Buckinghamshire, UK
    Drug Saf 30:1093-110. 2007
  8. ncbi request reprint Drugs, QTc interval prolongation and final ICH E14 guideline : an important milestone with challenges ahead
    Rashmi R Shah
    Rashmi Shah Pharmaceutical Services, Gerrards Cross, Buckinghamshire, UK
    Drug Saf 28:1009-28. 2005
  9. pmc A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 76:396-411. 2013
  10. pmc The significance of QT interval in drug development
    Rashmi R Shah
    Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, SW8 5NQ, UK
    Br J Clin Pharmacol 54:188-202. 2002

Detail Information

Publications23

  1. pmc ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 75:959-65. 2013
    ..Therefore, locally read ECGs should only be acceptable as long as accurate high quality ECG data can be guaranteed...
  2. doi request reprint Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, 8 Birchdale, Gerrards Cross, Buckinghamshire, SL9 7JA, UK
    Drug Saf 36:491-503. 2013
    ..Post-marketing experience with drugs such as imatinib, lapatinib and sorafenib suggests that the hepatotoxic safety of all the TKIs requires diligent surveillance. ..
  3. doi request reprint Cardiovascular safety of tyrosine kinase inhibitors: with a special focus on cardiac repolarisation (QT interval)
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, 8 Birchdale, Gerrards Cross, Buckinghamshire SL9 7JA, UK
    Drug Saf 36:295-316. 2013
    ....
  4. pmc Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 75:347-58. 2013
    ....
  5. pmc Personalized medicine: is it a pharmacogenetic mirage?
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 74:698-721. 2012
    ....
  6. pmc Drug-induced QT interval shortening: potential harbinger of proarrhythmia and regulatory perspectives
    Rashmi 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...
  7. ncbi request reprint Cardiac repolarisation and drug regulation: assessing cardiac safety 10 years after the CPMP guidance
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, Buckinghamshire, UK
    Drug Saf 30:1093-110. 2007
    ....
  8. ncbi request reprint Drugs, QTc interval prolongation and final ICH E14 guideline : an important milestone with challenges ahead
    Rashmi R Shah
    Rashmi Shah Pharmaceutical Services, Gerrards Cross, Buckinghamshire, UK
    Drug Saf 28:1009-28. 2005
    ....
  9. pmc A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Br J Clin Pharmacol 76:396-411. 2013
    ..Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations...
  10. pmc The significance of QT interval in drug development
    Rashmi R Shah
    Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, SW8 5NQ, UK
    Br J Clin Pharmacol 54:188-202. 2002
  11. ncbi request reprint Drug-induced QT interval prolongation: regulatory perspectives and drug development
    Rashmi 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...
  12. ncbi request reprint Mechanistic basis of adverse drug reactions: the perils of inappropriate dose schedules
    Rashmi 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...
  13. doi request reprint 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...
  14. ncbi request reprint Drugs, QT interval prolongation and ICH E14: the need to get it right
    Rashmi R Shah
    Medicines and Healthcare products Regulatory Agency, London SW8 5NQ, UK
    Drug Saf 28:115-25. 2005
    ....
  15. ncbi request reprint Drug-induced QT interval prolongation--regulatory guidance and perspectives on hERG channel studies
    Rashmi 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...
  16. doi request reprint Tyrosine kinase inhibitors: their on-target toxicities as potential indicators of efficacy
    Devron R Shah
    Rashmi Shah Consultancy Ltd, Birchdale, Gerrards Cross, Buckinghamshire SL9 7JA, UK
    Drug Saf 36:413-26. 2013
    ..Prospective studies are needed to investigate this proposition further...
  17. doi request reprint Early investigation of QTc liability: the role of multiple ascending dose (MAD) study
    Rashmi R Shah
    Rashmi Shah Consultancy Ltd, Gerrards Cross, UK
    Drug Saf 35:695-709. 2012
    ..In the event that a TQT study is considered unnecessary, there are obvious significant savings without compromising collection of vital safety data...
  18. ncbi request reprint Pharmacogenetic aspects of drug-induced torsade de pointes: potential tool for improving clinical drug development and prescribing
    Rashmi 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...
  19. ncbi request reprint Drug-induced prolongation of the QT interval: regulatory dilemmas and implications for approval and labelling of a new chemical entity
    Rashmi R Shah
    Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, UK
    Fundam Clin Pharmacol 16:147-56. 2002
  20. ncbi request reprint 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...
  21. pmc 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
  22. ncbi request reprint Refining detection of drug-induced proarrhythmia: QT interval and TRIaD
    Rashmi 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...
  23. ncbi request reprint 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