| Rashmikant Rasiklal SHAH * BSc (Hons) 2(i) classification (Physiology) (The University of London) * LRCP, MRCS (The Conjoint Examining Board of England) * MBBS (The University of London) * FRCP (Ed) (The Royal College of Physicians – Edinburgh) * FFPM (UK) The Faculty of Pharmaceutical Medicine (The Royal College of Physicians) Thesis: * MD (Lon) (The University of London) “Genetic Susceptibility to Adverse Drug Reactions: A clinical expression of deficient drug oxidation phenotype”. PUBLICATIONS Papers 1. Taylor-Roberts T, Shah RR The Physiology of Strolling. St. Mary’s Hosp. Gaz. 1967; LXXIII: 65 2. Shah RR Parenteral Nutrition – An Essential in Intensive Therapy. Clin.Trials J. 1976; 12(Suppl 1): 77 3. Oates RR, Shah RR, Idle JR, Smith RL. On the Urinary Disposition of Phenformin and 4-Hydroxy-Phenformin and Their Rapid Simultaneous Measurement. J.Pharm.Pharmacol. 1980; 32: 731. 4. Shah RR, Oates NS, Idle JR, Smith RL, Lockhart JDF. Impaired Oxidation of Debrisoquine in Patients with Perhexiline-Neuropathy. Br.Med.J. 1982; 284: 295 5. Oates NS, Shah RR, Idle JR, Smith RL. Genetic Polymorphism of Phenformin 4-Hydroxylation. Clin.Pharmacol.Ther. 1982; 32: 81 6. Waring RH, Mitchell SC, Shah RR, Idle JR, Smith RL. Polymorphic Sulphoxidation of S-Carboxymethyl-L-Cysteine in Man. Biochem.Pharmacol.Ther. 1982; 31: 3151 7. Shah RR, Oates NS, Idle JR, Smith RL, Lockhart JDF. Prediction of Subclinical Perhexiline Neuropathy in a Patient with an Inborn Error of Debrisoquine Hydroxylation. Am.Heart J 1983; 105: 159 8. Sloan TP, Lancaster R, Shah RR, Idle JR, Smith RL Genetically Determined Oxidation Capacity and the Disposition of Debrisoquine. Br.J.Clin.Pharmacol. 1983; 15: 443 9. Oates NS, Shah RR, Idle JR, Smith RL. The Influence of Oxidation Polymorphism on Phenformin Kinetics and Dynamics in Normal Volunteers. Clin.Pharmacol.Ther. 1983: 34: 827 10. Waring RH, Mitchell SC, Shah RR Metabolism of S-Carboxymethyl-L-Cysteine in Man: Isolation of a Ester Glucurconic Acid Conjugate from Urine. Xenobiotica 1983: 13: 311 11. Morgan MY, Reshef R, Shah RR, Oates NS, Smith RL, Sherlock S. Impaired Oxidation of Debrisoquine in Patients with Perhexiline. Liver Injury. Gut 1984; 25: 1057 12. Lanthier PL, Rewshef R, Shah RR, Oates NS, Smith RL, Morgan MY. Oxidation Phenotyping in Alcoholics with Liver Disease of Varying Severity. Alcoholism (New York) 1984 8: 435 13. Emery P, Panayi GS, Huston G, Welsh KI, Mitchell SC, Shah RR, Idle JR, Smith RL, Waring RH. D-Penicillamine Induced Toxicity in Rheumatoid-Arthritis – the Role of Sulphoxidation Status and HL-DR3. J.Rheumatology 1984; 11: 626 14. Haley CS, Waring RH, Mitchell SC, Shah RR, Idle JR, Smith RL. Lack of Congruence of S-Carboxymethyl-L-Cysteine Sulphnoxidation and Debrisoquine 4-Hydroxylation in a Caucasian Population Xenobiotica 1985; 15: 445 15. Shah RR, Evans DAP, Oates NS, Idle JR, Smith RL The Genetic Control of Phenformin 4-Hydroxylation. J.Med.Genet. 1985; 22: 361 16. Ritchie JC, Crothers MJ, Shah RR, Idle JR, Smith RL The Metabolism of Debrisoquine in Man: (a) Regioselectivity of Hydroxylation and (b) Aberrant Oxidative Metabolism in Two Sibling Patients with Carbimazole-Induced Agranulocytosis. Xenobiotica 1986; 16: 503 17. Shah RR Regulatory Assessment of Pharmacokinetic Data. BIRA Journal 1989; 8: 11 18. Shah RR, Wade G Reappraisal of the risk/benefit of nitrofurnation: review of toxicity and efficacy. Adverse Drug React. Acute Poisoning Rev 1989; 8: 183 19. Shah RR, Walley T ‘The Clinical and Scientific Basis of Drug Toxicity’: A report of a conference held at the Royal College of Physicians. J.Roy.Coll. Phys. London 1990 24: 213 20. Palace J, Shah RR, Clough C Flecainide-induced Peripheral Neuropathy Br.med.J. 1992 305: 810 21. Shah RR Clinical Pharmacokinetics : Current Requirements and Future Perspectives From a Regulatory Point of View Xenobiotica 1993; 23: 1159 22. Mitchell SC, Shah RR, Clements DG, Smith RL Changes in Debrisoquine Hydroxylation Capacity Following Liver Surgery Hum Exp. Toxicol 1994: 13: 537 23. Shah R. CPMP note for guidance: Clinical trials on the medicinal products in the treatment of cardiac failure. Methods Findings Exp Clin Pharmacol 1996: 18(Suppl C); 31 24. Shah RR, Midgley JM, Branch SK Stereochemical Origin of Some Clinically Significant Drug Safety Concerns; Lessons for future drug development Adverse Drug React Toxicol Rev 1998; 17: 145 25. Shah RR Drug-induced Hepatotoxicity: Pharmacokinetic perspectives and Strategies for risk reduction Adverse Drug React Toxicol Rev 1999; 18: 181 26. Shah RR The Influence of chirality on drug development Future Prescriber 2000; 1: 14 27. Shah RR. Implications of pharmacogenetics for the regulatory assessment of new chemical entities. Pharmaceutical News, 2000; 7: 32 28. Haverkamp W, Breithardt G, Camm AJ, Janse MJ, Rosen MR, Antzelevitch C, Escande D, Franz M, Malik M, Moss A, Shah R, et al. The Potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications Report on a policy conference of the European Society of Cardiology. Eur heart J, 2000; 21: 1216 29. Shah RR. Monitoring drug interactions. Pharmaceutical Physician 2001; 12: 18 30. Shah RR. Regulatory aspects of integration of pharmacogenetics into drug development. Int J Pharmaceut Med 2001; 15: 67 31. Shah RR. Thalidomide, drug safety and early drug regulation in the UK. Adverse Drug React Toxicol Rev 2001; 20: 199 32. Shah RR. The significance of QT interval in drug development. Br J Clin Pharmacol 2002; 54: 188 33. Shah RR. Drug-induced prolongation of the QT interval: why the regulatory concern? Fundam Clin Pharmacol 2002; 16: 119 34. Shah RR. Drug-induced prolongation of the QT interval: regulatory dilemmas and implications for approval and labelling of a new chemical entity. Fundam Clin Pharmacol 2002; 16: 147 35. Shah RR. Development of neuroleptic agents: pharmacogenetics and current safety issues of regulatory concern. Dialogues Clin Neurosci 2002; 4: 449 36. Shah RR. Drug interactions: Implications for pharmacogenetics in drug development. Eur Pharmaceut Contract 2002; Autumn issue: 68 37. Shah RR. Regulatory aspects of pharmacogenetics and pharmacogenomics. Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 2003; 46: 855 38. Shah RR. Pharmacogenetic aspects of drug-induced torsade de pointes: Potential tool for improving clinical drug development and prescribing. Drug Saf 2004; 27: 145 39. Shah RR. Drug-induced QT interval prolongation: Regulatory perspectives and drug development. Ann Med 2004; 36(Suppl 1): 47 40. Shah RR. Drug Development and Use in the Elderly: Search for the right dose and dosing regimen Br J Clin Pharmacol. 2004; 58: 452 41. Shah R, Darne B and Atar D, on behalf of the participants in the 5th Cardiovascular Clinical Trialists Workshop Pharmacogenomics in cardiovascular clinical trials. Fundam Clin Pharmacol 2004; 18: 705 42. Shah RR. Drug-induced QT dispersion: Does it predict the risk of torsade de pointes? J Electrocardiol. 2005; 38: 10 43. Shah RR. Mechanistic basis of adverse drug reactions: The perils of inappropriate dose schedules. Exp Opin Drug Saf 2005; 4: 103 44. Shah RR Drugs, QT Interval Prolongation and ICH E14: The Need to Get it Right Drug Saf. 2005; 28: 115 45. Shah RR The Latest Orphan Drug Designations and the Commission Communication on Regulation (EC) 141/2000 J Comm Biotech. 2005; 11: 228 46. Shah RR and Hondeghem LM Refining detection of drug-induced proarrhythmia: QT interval and TRIaD Heart Rhythm. 2005; 2: 758 47. Shah RR Pharmacogenetics in drug regulation: promise, potential and pitfalls Phil Trans R Soc B 2005; 360: 1617 48. Grisanti S, Morganroth J, Shah RR A practical approach to cardiac safety: Implementing ICH E14 to define cardiac safety in new drug development. Applied Clin Trials Supplement October 2005; 10 49. Shah RR Drugs, QTc interval and Final ICH E14 Guideline: An important milestone with challenges ahead. Drug Saf. 2005; 28: 1009 Abstracts 1. Idle JR, Oates NS, Shah RR, Smith RL. Is There a Genetic Predisposition to Phenformin-Induced Lactic Acidosis? Br.J.Clin.Pharmacol. 1981; 11: 418P 2. Oates NS, Shah RR, Lockhart JDF, Idle JR, Smith RL. Impaired Metabolic Oxidation in Perhexiline Neuropathy. In: Proceedings of the 8th International Congress of Pharmacology, Tokyo 1981; p.1985. 3. Oates NS, Shah RR, Drury PL, Idle JR, Smith RL. Captopril-induced Argranulocytosis Associated with an Impairment of Debrisoquine Hydroxylation. Br.J.Clin.Pharmacol. 1982; 14: 601P. 4. Shah RR, Oates NS, Idle JR, Smith RL, Zech K. The Influence of Oxidation Polymorphism on Urapidil Metabolism and Pharmacokinetics in Man. IUPHAR 9th International Congress of Pharmacology, London, 1984; p.995P. 5. Oates NS, Shah RR, Idle JR, Smith RL. The Metabolic Disposition of the Stereoisomers of Perhexiline Maleate and the Influence of Oxidation Phenotype. Br.J.Clin.Pharmacol. 1984; 18: 307P. 6. Oates NS, Crowther M, Shah RR, Idle JR, Smith RL. Influence of Dextropropoxyphene on Oxidation Phenotyping using Debrisoquine and Phenformin. In: III World Conference on Clinical Pharmacology and Therapeutics. Stockholm. Acta Pharmacol.et Toxic. 1986; 59: (Supple.V): 319P. 7. Shah RR The Regulatory Importance of Identifying Variability in Drug Metabolising Enzymes in the Clinical Evaluation and Registration of New Chemical Entities In: Proceedings of the 6th European ISSX Meeting in Gothenburg, Sweden, 1997, 11: 30. Letters 1. Shah RR, Oates NS, Idle JR, Smith RL. Genetic Impairment of Phenformin Metabolism. Lancet 1980; i: 1147. 2. Oates NS, Shah RR, Idle JR, Smith RL. Phenformin-Induced Lactic Acidosis associated with Impaired Debrisoquine Hydroxylation Lancet 1981; i 837. 3. Shah RR, Oates NS, Idle JR, Smith RL. Beta-blockers and Drug Oxidation Status. Lancet 1982; i: 508. 4. Shah RR, Oates NS, Idle JR, Smith RL. Beta-blockers and Drug Oxidation Status Lancet 1982; i: 1019. 5. Shah RR. Symptomatic Bradycardia in association with H2-receptor Antagonists. Lancet 1982; ii: 1108. 6. Shah RR. Histamine H2-Antagonists and the Heart. Lancet 1982; ii 1281. 7. Panayi GS, Houston G, Shah RR, Mitchell SC, Idle JR, Smith RL, Waring RH. Deficient Sulphoxidation Status and D-Pencillamine toxicity. Lancet 1983; i: 414. 8. Idle JR, Oates NS, Shah RR, Smith RL. Protecting Poor Metabolisers, a Group at High Risk of Adverse Drug Reactions. Lancet 1983; i: 1388. Chapters in Books 1. Idle JR, Oates NS, Ritchie JC, Shah RR, Sloan RP, Smith RL. “New Perspectives of Genetic Polymorphism in Drug Oxidation” In: "Advanced Medicine 16" Ed: Bellingham AJ Pitman Medical, Tunbridge Wells, 1980 2. Shah RR “Global Dossier: Acceptability of Foreign Clinical data in Drug Evaluation” In: "Drug Evaluation in the New Millennium" Ed: Ng Tju Lik. Centre for Drug Evaluation, Ministry of Health, Singapore, 2000 3. Shah RR “Risk Management in Drug Evaluation: Case studies” In: "Drug Evaluation in the New Millennium" Ed: Ng Tju Lik. Centre for Drug Evaluation, Ministry of Health, Singapore, 2000 4. Griffin JP, Shah RR “The development of the control of human medicines in Europe from classical times to the year 2000” In: “The Textbook of Pharmaceutical Medicine” (4th ed) Ed: Griffin JP and O’Grady J BMJ Books, London, 2002 5. Shah RR “Withdrawal of terodiline: A tale of two toxicities” In: "Pharmacovigilance" (1st ed) Ed: Mann R and Andrews E. John Wiley & Sons Ltd, Chichester, 2002 6. Shah RR “Improving clinical risk/benefit through stereochemistry” In: "Stereochemical Aspects of Drug Action and Disposition" Ed: Eichelbaum M, Testa B and Somogyi A. Handbook of Experimental Pharmacology Series Springer-Verlag, Heidelberg, 2003 7. Shah RR, Branch SK. “Regulatory requirements for the development of chirally active drugs” In: "Stereochemical Aspects of Drug Action and Disposition" Ed: Eichelbaum M, Testa B and Somogyi A. Handbook of Experimental Pharmacology Series Springer-Verlag, Heidelberg, 2003 8. Griffin JP, Shah RR “History of drug regulation in the UK” In: "The Regulation of Medicinal Products" Ed: Griffin JP and O'Grady J BMJ Publishing Group, London, 2003 9. Shah RR, Griffin JP “Regulation of human medicinal products in the European Union” In: "The Regulation of Medicinal Products" Ed: Griffin JP and O'Grady J. BMJ Publishing Group, London, 2003 |