Clinical pharmacology: Special safely considerations in drug development and pharmacovigilance

Drug Safety

Volumn 27, Issue 8, 2004, Pages 535-554

  Atuah, Kwame N ^a   Hughes, Dyfrig ^a   Pirmohamed, Munir ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIDEPRESSANT AGENT; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; BICARBONATE; CARBAMAZEPINE; CISAPRIDE; DIAZEPAM; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; GLYCERYL TRINITRATE; HYPERICUM PERFORATUM EXTRACT; IMMUNOSUPPRESSIVE AGENT; METIPRANOLOL; MIBEFRADIL; MIDAZOLAM; NEUROLEPTIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; OXYBUTYNIN; PARACETAMOL; PHENOBARBITAL; PHENYTOIN; PROBENECID; PROPRANOLOL DERIVATIVE; SALBUTAMOL; UNINDEXED DRUG; VERAPAMIL; VIGABATRIN; WARFARIN;

ACUTE KIDNEY FAILURE; AGRANULOCYTOSIS; ALLOMETRY; ANTIHYPERTENSIVE ACTIVITY; BLEEDING; BLOOD TOXICITY; BONE MARROW SUPPRESSION; COMORBIDITY; CONSTIPATION; DOSE RESPONSE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXCRETION; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENTIATION; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GENOTYPE; GRAFT REJECTION; HUMAN; HYPERTENSION; HYPOTENSION; IMMUNE SYSTEM; INTOXICATION; LIVER TOXICITY; MUTAGENICITY; NEUROTOXICITY; OPTIMAL DRUG DOSE; PANCYTOPENIA; PHARMACOGENETICS; PREDICTION; PRIORITY JOURNAL; PROTEINURIA; QT PROLONGATION; RASH; REVIEW; SEDATION; SEX DIFFERENCE; SIDE EFFECT; TASTE DISORDER; TERATOGENICITY; TOXIC EPIDERMAL NECROLYSIS; TOXICITY; UVEITIS; VISUAL FIELD DEFECT; XEROSTOMIA;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; CLINICAL TRIALS; DRUG DESIGN; FEMALE; HUMANS; INFANT, NEWBORN; MALE; PHARMACOKINETICS; PHARMACOLOGY, CLINICAL; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 3042653096     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200427080-00006     Document Type: Review

References (172)

1. Dollery C. Clinical pharmacology: future prospects for the discipline. Br J Clin Pharmacol 1996; 42 (1): 137-41
2. Korfmacher WA. Lead optimization strategies as part of a drug metabolism environment. Curr Opin Drug Discov Devel 2003; 6 (4): 481-5
3. Roberts SA. High-throughput screening approaches for investigating drug metabolism and pharmacokinetics. Xenobiotica 2001; 31 (8-9): 557-89
4. Netzer R, Ebneth A, Bischoff U, et al. Screening lead compounds for QT interval prolongation. Drug Discov Today 2001; 6 (2): 78-84
5. Waring JF, Ulrich RG. The impact of genomics-based technologies on drug safety evaluation. Annu Rev Pharmacol Toxicol 2000; 40: 335-52
6. Curry S, McCarthy D, DeCroy HH, et al. Phase I: the first opportunity for extrapolation form animal data to human expsoure. In: Fletcher AJ, Edwards LD, Fox AW, et al., editors. Principles and practice of pharmaceutical medicine. Chichester, UK: Wiley, 2002: 95-115
7. Obach RS, Baxter JG, Liston TE, et al. The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 1997; 283 (1): 46-58
8. Boxenbaum H, DiLea C. First-time-in-human dose selection: allometric thoughts and perspectives. J Clin Pharmacol 1995; 35 (10): 957-66
9. Ubeaud G, Schmitt C, Jaeck D, et al. Bosentan, a new endothelin receptor antagonist: prediction of the systemic plasma clearance in man from combined in vivo and in vitro data. Xenobiotica 1995; 25 (12): 1381-90
10. Lave T, Schmitt-Hoffmann AH, Coassolo P, et al. A new extrapolation method from animals to man: application to a metabolized compound, mofarotene. Life Sci 1995; 56 (26): PL473-8
11. Raven A. Consider it pure joy: an introduction to clinical trials. 3rd ed. Cambridge, UK: Cambridge Healthcare Research, 1997
12. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 2nd ed. Littleton (MA): PSG Publishing Co., Inc., 1985
13. Fox AW. Phase II and phase III clinical trials. In: Fletcher AJ, Edwards LD, Fox AW, et al., editors. Principles and practice of pharmaceutical medicine. 1st ed. Chichester, UK: Wiley, 2002: 117-32
14. Holford NH, Sheiner LB. Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clin Pharmacokinet 1981; 6 (6): 429-53
15. Meibohm B, Derendorf H. Pharmacokinetic/pharmacodynamic studies in drug product development. J Pharm Sci 2002; 91 (1): 18-31
16. Sheiner LB, Ludden TM. Population pharmacokinetics/dynamics. Annu Rev Pharmacol Toxicol 1992; 32: 185-209
17. Vozeh S, Steimer JL, Rowland M, et al. The use of population pharmacokinetics in drug development. Clin Pharmacokinet 1996; 30 (2): 81-93
18. Holford NH, Kimko HC, Monteleone JP, et al. Simulation of clinical trials. Annu Rev Pharmacol Toxicol 2000; 40: 209-34
19. Bonate PL. Clinical trial simulation in drug development. Pharm Res 2000; 17 (3): 252-6
20. Gieschke R, Reigner BG, Steimer JL. Exploring clinical study design by computer simulation based on pharmacokinetic/pharmacodynamic modelling. Int J Clin Pharmacol Ther 1997; 35 (10): 469-74
21. Gupta SK, Sathyan G, Lindemulder EA, et al. Quantitative characterization of therapeutic index: application of mixed-effects modeling to evaluate oxybutynin dose-efficacy and dose-side effect relationships. Clin Pharmacol Ther 1999; 65 (6): 672-84
22. Graham G, Gupta S, Aarons L. Determination of an optimal dosage regimen using a Bayesian decision analysis of efficacy and adverse effect data. J Pharmacokinet Pharmacodyn 2002; 29 (1): 67-88
23. Lassila HC, Stoehr GP, Ganguli M, et al. Use of prescription medications in an elderly rural population: the MoVIES Project. Ann Pharmacother 1996; 30 (6): 589-95
24. Conn VS. Self-management of over-the-counter medications by older adults. Public Health Nurs 1992; 9 (1): 29-36
25. Williams BR, Kim J. Cardiovascular drug therapy in the elderly: theoretical and practical considerations. Drugs Aging 2003; 20 (6): 445-63
26. Avorn J. Including elderly people in clinical trials. BMJ 1997; 315 (7115): 1033-4
27. Kitler ME. Clinical trials in the elderly: pivotal points. Clin Geriatr Med 1990; 6 (2): 235-55
28. EMEA. ICH Topic E7 Studies in support of special populations: geriatrics. London: The European Agency for the Evaluation of Medicinal Products (EMEA), 1994
29. EMEA. ICH Topic E11. Clinical investigation of medicinal products in the pediatric patient. European Agency for the Evaluation of Medicinal Products (EMEA), 2001
30. Udkow G. Pediatric clinical pharmacology, a practical review. Am J Dis Child 1978; 132 (10): 1025-32
31. King JR, Kimberlin DW, Aldrovandi GM, et al. Antiretroviral pharmacokinetics in the paediatric population: a review. Clin Pharmacokinet 2002; 41 (14): 1115-33
32. Edwards LD. Clinical research in children. In: Fletcher AJ, Edwards LD, Fox AW, et al., editors. Principles and practice of pharmaceutical medicine. Chichester, UK: John Wiley & Sons, 2002
33. Cresteil T, Beaune P, Kremers P, et al. Immunoquantification of epoxide hydrolase and cytochrome P-450 isozymes in fetal and adult human liver microsomes. Eur J Biochem 1985; 151 (2): 345-50
34. Lacroix D, Sonnier M, Moncion A, et al. Expression of CYP3A in the human liver: evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur J Biochem 1997; 247 (2): 625-34
35. Treluyer JM, Rey E, Sonnier M, et al. Evidence of impaired cisapride metabolism in neonates. Br J Clin Pharmacol 2001; 52 (4): 419-25
36. Kearns GL, Robinson PK, Wilson JT, et al. Cisapride disposition in neonates and infants: in vivo reflection of cytochrome P450 3A4 ontogeny. Clin Pharmacol Ther 2003; 74 (4): 312-25
37. Jacobs RF, Kearns GL, Brown AL, et al. Renal clearance of imipenem in children. Eur J Clin Microbiol 1984; 3 (5): 471-4
38. Freij BJ, McCracken Jr GH, Olsen KD, et al. Pharmacokinetics of imipenem-cilastatin in neonates. Antimicrob Agents Chemother 1985; 27 (4): 431-5
39. Strolin Benedetti M, Baltes EL. Drug metabolism and disposition in children. Fundam Clin Pharmacol 2003; 17 (3): 281-99
40. Roberts R, Rodriguez W, Murphy D, et al. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA 2003; 290 (7): 905-11
41. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries: European Network for Drug Investigation in Children. BMJ 2000; 320 (7227): 79-82
42. Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol 2003; 17 (1): 125-31
43. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54 (6): 665-70
44. Turner S, Nunn AJ, Fielding K. et al. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88 (9): 965-8
45. Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52 (1): 77-83
46. Wong I, Sweis D, Cope J, et al. Paediatric medicines research in the UK: how to move forward? Drug Saf 2003; 26 (8): 529-37
47. Allen AJ, Michelson D. Drug development process for a product with a primary pediatric indication. J Clin Psychiatry 2002; 63 Suppl. 12: 44-9
48. Giacoia GP. Incentive to study drugs in children and other governmental initiatives: will patients with asthma benefit? J Allergy Clin Immunol 2000; 106 (3 Suppl.): S118-24
49. Marwick C. Implementing the FDA Modernization Act. JAMA 1998; 279 (11): 815-6
50. Berlin Jr CM. Challenges in conducting pediatric drug trials. J Allergy Clin Immunol 2000; 106 (3 Suppl.): S125-7
51. United States District Court for the District of Columbia. Association of American Physicians and Surgeons, Inc., et al. (Plaintiffs) v. United States Food and Drug Administration, et al. (Defendants). Civil Action 00-02898 (HHK). Memorandum opinion [online]. Available from URL: http://www.dcd.uscourts.gov/00- 02898.pdf [Accessed 2004 Apr 29]
52. One Hundred Eighth Congress of the United States of America [online]. Available from URL: http://www.fda.gov/cder/pediatric/S-650-PREA.pdf [Accessed 2004 May 10]
53. Edwards LD. Drug development research in women. In: Fletcher AJ, Edwards LD, Fox AW, et al., editors. Principles and practice of pharmaceutical medicine. Chichester, UK: John Wiley & Sons, 2002
54. Buring JE. Women in clinical trials: a portfolio for success. N Engl J Med 2000; 343 (7): 505-6
55. Miaskiewicz SL, Shively CA, Vesell ES. Sex differences in absorption kinetics of sodium salicylate. Clin Pharmacol Ther 1982; 31 (1): 30-7
56. Walle T, Walle UK, Cowart TD, et al. Pathway-selective sex differences in the metabolic clearance of propranolol in human subjects. Clin Pharmacol Ther 1989; 46 (3): 257-63
57. Meibohm B, Beierle I, Derendorf H. How important are gender differences in pharmacokinetics? Clin Pharmacokinet 2002; 41 (5): 329-42
58. Schwartz JB. The influence of sex on pharmacokinetics. Clin Pharmacokinet 2003; 42 (2): 107-21
59. Krecic-Shepard ME, Barnas CR, Slimko J, et al. Faster clearance of sustained release verapamil in men versus women: continuing observations on sex-specific differences after oral administration of verapamil. Clin Pharmacol Ther 2000; 68 (3): 286-92
60. Krecic-Shepard ME, Barnas CR, Slimko J, et al. Gender-specific effects on verapamil pharmacokinetics and pharmacodynamics in humans. J Clin Pharmacol 2000; 40 (3): 219-30
61. Greenblatt DJ, Harmatz JS, von Moltke LL, et al. Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex-dependent differences. J Pharmacol Exp Ther 2000; 293 (2): 435-43
62. Ochs HR, Greenblatt DJ, Divoll M, et al. Diazepam kinetics in relation to age and sex. Pharmacology 1981; 23 (1): 24-30
63. Schroeder TJ, Cho MJ, Pollack GM, et al. Comparison of two cyclosporine formulations in healthy volunteers: bioequivalence of the new Sang-35 formulation and Neoral. J Clin Pharmacol 1998; 38 (9): 807-14
64. Sloan JA, Goldberg RM, Sargent DJ, et al. Women experience greater toxicity with fluorouracil-based chemotherapy for colorectal cancer. J Clin Oncol 2002; 20 (6): 1491-8
65. Stockley IH. Stockley's drug interactions. 6th ed. London: Pharmaceutical Press, 2002
66. EMEA/CPMP. Note for guidance on the investigation of drug interactions. London: The European Agency for the Evaluation of Medicinal Products/Committee for Proprietary Medicinal Products, 1998
67. Lelawongs P, Barone JA, Colaizzi JL, et al. Effect of food and gastric acidity on absorption of orally administered ketoconazole. Clin Pharm 1988; 7 (3): 228-35
68. Wells PS, Holbrook AM, Crowther NR, et al. Interactions of warfarin with drugs and food. Ann Intern Med 1994; 121 (9): 676-83
69. Sansom LN, Evans AM. What is the true clinical significance of plasma protein binding displacement interactions? Drug Saf 1995; 12 (4): 227-33
70. MacKichan JJ. Pharmacokinetic consequences of drug displacement from blood and tissue proteins. Clin Pharmacokinet 1984; 9 Suppl. 1: 32-41
71. Sketris IS, Wright MR, West ML. Possible role of the intestinal P-450 enzyme system in a cyclosporine-clarithromycin interaction. Pharmacotherapy 1996; 16 (2): 301-5
72. Yee GC, McGuire TR. Pharmacokinetic drug interactions with cyclosporin (Part I). Clin Pharmacokinet 1990; 19 (4): 319-32
73. Cascorbi I. Pharmacogenetics of cytochrome p4502D6: genetic background and clinical implication. Eur J Clin Invest 2003; 33 Suppl. 2: 17-22
74. Bonate PL, Reith K, Weir S. Drug interactions at the renal level: implications for drug development. Clin Pharmacokinet 1998; 34 (5); 375-404
75. Basin KS, Escalante A, Beardmore TD. Severe pancytopenia in a patient taking low dose methotrexate and probenecid. J Rheumatol 1991; 18 (4): 609-10
76. McLeod HL. Clinically relevant drug-drug interactions in oncology. Br J Clin Pharmacol 1998; 45 (6): 539-44
77. Giovanni G, Giovanni P. Do non-steroidal anti-inflammatory drugs and COX-2 selective inhibitors have different renal effects? J Nephrol 2002; 15 (5): 480-8
78. Morgan T, Anderson A. The effect of nonsteroidal anti-inflammatory drugs on blood pressure in patients treated with different antihypertensive drugs. J Clin Hypertens (Greenwich) 2003; 5 (1): 53-7
79. Gambaro G, Perazella MA. Adverse renal effects of anti-inflammatory agents: evaluation of selective and nonselective cyclooxygenase inhibitors. J Intern Med 2003; 253 (6): 643-52
80. Gottesman MM, Pastan I. Biochemistry of multidrug resistance mediated by the multidrug transporter. Annu Rev Biochem 1993; 62: 385-427
81. Lin JH. Drug-drug interaction mediated by inhibition and induction of P-glycoprotein. Adv Drug Deliv Rev 2003; 55 (1): 53-81
82. Hunter J, Hirst BH, Simmons NL. Drug absorption limited by P-glycoprotein-mediated secretory drug transport in human intestinal epithelial Caco-2 cell layers. Pharm Res 1993; 10 (5): 743-9
83. Sparreboom A, van Asperen J, Mayer U, et al. Limited oral bioavailability and active epithelial excretion of paclitaxel (Taxol) caused by P-glycoprotein in the intestine. Proc Natl Acad Sci U S A 1997; 94 (5): 2031-5
84. Meerum Terwogt JM, Malingre MM, Beijnen JH, et al. Coadministration of oral cyclosporin A enables oral therapy with paclitaxel. Clin Cancer Res 1999; 5 (11): 3379-84
85. Malingre MM, Richel DJ, Beijnen JH, et al. Coadministration of cyclosporine strongly enhances the oral bioavailability of docetaxel. J Clin Oncol 2001; 19 (4): 1160-6
86. Verstuyft C, Schwab M, Schaeffeler E, et al. Digoxin pharmacokinetics and MDR1 genetic polymorphisms. Eur J Clin Pharmacol 2003; 58 (12): 809-12
87. Verschraagen M, Koks CH, Schellens JH, et al. P-glycoprotein system as a determinant of drug interactions: the case of digoxin-verapamil. Pharmacol Res 1999; 40 (4): 301-6
88. Greiner B, Eichelbaum M, Fritz P, et al. The role of intestinal P-glycoprotein in the interaction of digoxin and rifampin. J Clin Invest 1999; 104 (2): 147-53
89. Johne A, Brockmoller J, Bauer S, et al. Pharmacokinetic interaction of digoxin with an herbal extract from St John's wort (Hypericum perforatum). Clin Pharmacol Ther 1999; 66 (4): 338-45
90. Mai I, Stormer E, Bauer S, et al. Impact of St John's wort treatment on the pharmacokinetics of tacrolimus and mycophenolic acid in renal transplant patients. Nephrol Dial Transplant 2003; 18 (4): 819-22
91. de Maat MM, Hoetelmans RM, Math t RA, et al. Drug interaction between St John's wort and nevirapine. AIDS 2001; 15 (3): 420-1
92. Piscitelli SC, Burstein AH, Chaitt D, et al. Indinavir concentrations and St John's wort. Lancet 2000; 355 (9203): 547-8
93. Kalow W. Pharmacogenetics and personalised medicine. Fundam Clin Pharmacol 2002; 16 (5): 337-42
94. Roses AD. Pharmacogenetics and future drug development and delivery. Lancet 2000; 355 (9212): 1358-61
95. Hiratsuka M, Mizugaki M. Genetic polymorphisms in drug-metabolising enzymes and drug targets. Mol Genet Metab 2001; 73: 298-305
96. Pirmohamed M, Park BK. Genetic susceptibility to adverse drug reactions. Trends Pharmacol Sci 2001; 22 (6): 298-305
97. Pirmohamed M, Park BK. Cytochrome P450 enzyme polymorphisms and adverse drug reactions. Toxicology 2003; 192: 23-32
98. Ingelman-Sundberg M. Pharmacogenetics: an opportunity for a safer and more efficient pharmacotherapy. J Intern Med 2001; 250: 186-200
99. Brazell C, Freeman A, Mosteller M. Maximizing the value of medicines by including pharmacogenetic research in drug development and surveillance. Br J Clin Pharmacol 2002; 53 (3): 224-31
100. Duggan DJ, Bittner M, Chen Y, et al. Expression profiling using cDNA microarrays. Nat Genet 1999; 21 (1 Suppl.): 10-4
101. Ozdemir V, Shear NH, Kalow W. What will be the role of Pharmacogenetics in evaluating drug safety and minimising adverse effects? Drug Saf 2001; 24 (2): 75-85
102. Phillips KA, Veenstra DL, Oren E, et al. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 2001; 286 (18): 2270-9
103. Sachse C, Brockmoller J, Bauer S, et al. Cytochrome P450 2D6 variants in a Caucasian population: allele frequencies and phenotypic consequences. Am J Hum Genet 1997; 60 (2): 284-95
104. Broly F, Gaedigk A, Heim M, et al. Debrisoquine/sparteine hydroxylation genotype and phenotype: analysis of common mutations and alleles of CYP2D6 in a European population. DNA Cell Biol 1991; 10 (8): 545-58
105. Gaedigk A, Blum M, Gaedigk R, et al. Deletion of the entire cytochrome P450 CYP2D6 gene as a cause of impaired drug metabolism in poor metabolizers of the debrisoquine/sparteine polymorphism. Am J Hum Genet 1991; 48 (5): 943-50
106. Bertilsson L, Dahl ML, Dalen P, et al. Molecular genetics of CYP2D6: clinical relevance with focus on psychotropic drugs. Br J Clin Pharmacol 2002; 53 (2): 111-22
107. Bertilsson L, Dahl ML, Tybring G. Pharmacogenetics of antidepressants: clinical aspects. Acta Psychiatr Scand Suppl 1997; 391: 14-21
108. Lee CR, Goldstein JA, Pieper JA. Cytochrome P450 2C9 polymorphisms: a comprehensive review of the in-vitro and human data. Pharmacogenetics 2002; 12 (3): 251-63
109. Doecke CJ, Veronese ME, Pond SM, et al. Relationship between phenytoin and tolbutamide hydroxylations in human liver microsomes. Br J Clin Pharmacol 1991; 31 (2): 125-30
110. Ninomiya H, Mamiya K, Matsuo S, et al. Genetic polymorphism of the CYP2C subfamily and excessive serum phenytoin concentration with central nervous system intoxication. Ther Drug Monit 2000; 22 (2): 230-2
111. Connell WR, Kamm MA, Ritchie JK, et al. Bone marrow toxicity caused by azathioprine in inflammatory bowel disease: 27 years of experience. GUT 1993; 34 (8): 1081-5
112. Weinshilboum RM, Otterness DM, Szumlanski CL. Methylation pharmacogenetics: catechol O-methyltransferase, thiopurine methyltransferase, and histamine N-methyltransferase. Annu Rev Pharmacol Toxicol 1999; 39: 19-52
113. Leipold G, Schutz E, Haas JP, et al. Azathioprine-induced severe pancytopenia due to a homozygous two-point mutation of the thiopurine methyltransferase gene in a patient with juvenile HLA-B27-associated spondylarthritis. Arthritis Rheum 1997; 40 (10): 1896-8
114. Black AJ, McLeod HL, Capell HA, et al. Thiopurine methyltransferase genotype predicts therapy-limiting severe toxicity from azathioprine. Ann Intern Med 1998; 129 (9): 716-8
115. Liggett SB. beta(2)-adrenergic receptor pharmacogenetics. Am J Respir Crit Care Med 2000; 161 (3 Pt 2): S197-201
116. Fenech A, Hall IP. Pharmacogenetics of asthma. Br J Clin Pharmacol 2002; 53 (1): 3-15
117. Priori SG, Barhanin J, Hauer RN, et al. Genetic and molecular basis of cardiac arrhythmias: impact on clinical management parts I and II. Circulation 1999; 99 (4): 518-28
118. Heerdink ER, Urquhart J, Leufkens HG. Changes in prescribed drug doses after market introduction. Pharmacoepidemiol Drug Saf 2002; 11 (6): 447-53
119. Cross J, Lee H, Westelinck A, et al. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Pharmacoepidemiol Drug Saf 2002; 11 (6): 439-46
120. Struijker Boudier HA. A drug is not a drug is not a drug: a commentary. Pharmacoepidemiol Drug Saf 2002; 11 (6): 437-8
121. Ferguson RK, Vlasses PH. Clinical pharmacology and therapeutic applications of the new oral angiotensin converting enzyme inhibitor, captopril. Am Heart J 1981; 101 (5): 650-6
122. Heel RC, Brogden RN, Speight TM, et al. Captopril: a preliminary review of its pharmacological properties and therapeutic efficacy. Drugs 1980; 20 (6): 409-52
123. Frohlich ED, Cooper RA, Lewis EJ. Review of the overall experience of captopril in hypertension. Arch Intern Med 1984; 144 (7): 1441-4
124. Waeber B, Gavras I, Brunner HR, et al. Safety and efficacy of chronic therapy with captopril in hypertensive patients: an update. J Clin Pharmacol 1981; 21 (11-12 Pt 1): 508-16
125. Low-dose captopril for the treatment of mild to moderate hypertension. I: results of a 14-week trial. Veterans Administration Cooperative Study Group on Antihypertensive Agents. Arch Intern Med 1984; 144 (10): 1947-53
126. Jenkins AC, Dreslinski GR, Tadros SS, et al. Captopril in hypertension; seven years later. J Cardiovasc Pharmacol 1985; 7 Suppl. 1: S96-101
127. Vlasses PH, Ferguson RK, Chatterjee K. Captopril: clinical pharmacology and benefit-to-risk ratio in hypertension and congestive heart failure. Pharmacotherapy 1982; 2 (1): 1-17
128. Schoenberger JA, Croog SH, Sudilovsky A, et al. Self-reported side effects from antihypertensive drugs: a clinical trial. Quality of Life Research Group. Am J Hypertens 1990; 3 (2): 123-32
129. WHO-UMC. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: World Health Organization Uppsala Monitoring Centre, 2002
130. Peachey J. From pharmacovigilance to pharmacoperformance. Drug Saf 2002; 25 (6): 399-405
131. Mann RD. Introduction. In: Mann RD, Andrews E, editors. Pharmacovigilance. Chichester, UK: John Wiley & Sons Ltd, 2002
132. Rawlins MD. Clinical pharmacology: adverse reactions to drugs. BMJ (Clin Res Ed) 1981; 282 (6268): 974-6
133. Royer JR. Mechanism of action of adverse drug reactions: an overview. Pharmacoepidem Drug Saf 1997; 6 Suppl. 3: S43-50
134. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356 (9237): 1255-9
135. Aronson JK, Ferner RE. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ 2003; 327 (7425): 1222-5
136. Pirmohamed M, Breckenridge A, Kitteringham NR, et al. Adverse drug reactions. BMJ 1998 Apr; 316 (7140): 1295-8
137. Naisbitt DJ, Gordon SF, Pirmohamed M, et al. Immunological principles of adverse drug reactions: the initiation and propagation of immune responses elicited by drug treatment. Drug Saf 2000; 23 (6): 483-507
138. Park BK, Kitteringham NR, Powell H, et al. Advances in molecular toxicology-towards understanding idiosyncratic drug toxicity. Toxicology 2000; 153 (1-3): 39-60
139. Naisbitt DJ, Pirmohamed M, Park BK. Immunopharmacology of hypersensitivity reactions to drugs. Curr Allergy Asthma Rep 2003; 3 (1): 22-9
140. Park BK, Naisbitt DJ, Gordon SF, et al. Metabolic activation in drug allergies. Toxicology 2001; 158 (1-2): 11-23
141. Pirmohamed M, Naisbitt DJ, Gordon F, et al. The danger hypothesis: potential role in idiosyncratic drug reactions. Toxicology 2002; 181-182: 55-63
142. Tanaka E, Yamazaki K, Misawa S. Update: the clinical importance of acetaminophen hepatotoxicity in non-alcoholic and alcoholic subjects. J Clin Pharm Ther 2000; 25 (5): 325-32
143. Grindulis KA, McConkey B. Rheumatoid arthritis: the effects of treatment with dapsone on hemoglobin. J Rheumatol 1984; 11 (6): 776-8
144. Lee BL, Medina I, Benowitz NL, et al. Dapsone, trimethoprim, and sulfamethoxazole plasma levels during treatment of Pneumocystis pneumonia in patients with the acquired immunodeficiency syndrome (AIDS): evidence of drug interactions. Ann Intern Med 1989; 110 (8): 606-11
145. Zuidema J, Hilbers-Modderman ES, Merkus FW. Clinical pharmacokinetics of dapsone. Clin Pharmacokinet 1986; 11 (4): 299-315
146. Glader BE, Conrad ME. Hemolysis by diphenylsulfones: comparative effects of DDS and hydroxylamine-DDS. J Lab Clin Med 1973; 81 (2): 267-72
147. Uetrecht J, Zahid N, Shear NH, et al. Metabolism of dapsone to a hydroxylamine by human neutrophils and mononuclear cells. J Pharmacol Exp Ther 1988; 245 (1): 274-9
148. Riley RJ, Roberts P, Coleman MD, et al. Bioactivation of dapsone to a cytotoxic metabolite: in vitro use of a novel two compartment system which contains human tissues. Br J Clin Pharmacol 1990; 30 (3): 417-26
149. Tingle MD, Coleman MD, Park BK. An investigation of the role of metabolism in dapsone-induced methaemoglobinaemia using a two compartment in vitro test system. Br J Clin Pharmacol 1990; 30 (6): 829-38
150. Tingle MD, Coleman MD, Park BK. The effect of preincubation with cimetidine on the N-hydroxylation of dapsone by human liver microsomes. Br J Clin Pharmacol 1991; 32 (1): 120-3
151. Coleman MD, Scott AK, Breckenridge AM, et al. The use of cimetidine as a selective inhibitor of dapsone N-hydroxylation in man. Br J Clin Pharmacol 1990; 30 (5): 761-7
152. Rhodes LE, Tingle MD, Park BK, et al. Cimetidine improves the therapeutic/toxic ratio of dapsone in patients on chronic dapsone therapy. Br J Dermatol 1995; 132 (2): 257-62
153. Zanni MP, Schnyder B, von Greyerz S, et al. Involvement of T cells in drug-induced allergies. Trends Pharmacol Sci 1998; 19 (8): 308-10
154. Griem P, Wulferink M, Sachs B, et al. Allergic and autoimmune reactions to xenobiotics: how do they arise? Immunol Today 1998; 19 (3): 133-41
155. Schnyder B, Mauri-Hellweg D, Zanni M, et al. Direct, MHC-dependent presentation of the drug sulfamethoxazole to human alphabeta T cell clones. J Clin Invest 1997; 100 (1): 136-41
156. Anderson CC, Matzinger P. Danger: the view from the bottom of the cliff. Semin Immunol 2000; 12 (3): 231-8
157. Yamey G. UK's yellow card scheme to be extended. BMJ 1999; 319 (7221): 1322B
158. Morrison-Griffiths S, Walley TJ, Park BK, et al. Reporting of adverse drug reactions by nurses. Lancet 2003; 361 (9366): 1347-8
159. Friedman MA, Woodcock J, Lumpkin MM, et al. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999; 281 (18): 1728-34
160. Davis S, Raine JM. Spontaneous reporting - UK. In: Mann RD, Andrews E, editors. Pharmacovigilance. Chichester, UK: John Wiley & Sons Ltd, 2002
161. Pirmohamed M, Park BK. Adverse drug reactions: back to the future. Br J Clin Pharmacol 2003; 55 (5): 486-92
162. Alvarez-Requejo A, Carvajal A, Begaud B, et al. Under-reporting of adverse drug reactions: estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1998; 54 (6): 483-8
163. Eland IA, Belton KJ, van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48 (4): 623-7
164. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30 (2): 239-45
165. Karch FE, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21 (3): 247-54
166. Venulet J. Aspects of standardization as applied to the assessment of drug-event associations. Drug Inf J 1984; 18 (3-4): 199-210
167. Jones JK. Adverse drug reactions in the community health setting: approaches to recognizing, counseling, and reporting. Fam Community Health 1982; 5 (2): 58-67
168. Hutchinson TA, Flegel KM, HoPingKong H, et al. Reasons for disagreement in the standardized assessment of suspected adverse drug reactions. Clin Pharmacol Ther 1983; 34 (4): 421-6
169. Macedo AF, Marques FB, Ribeiro CF, et al. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability. J Clin Pharm Ther 2003; 28 (2): 137-43
170. Hutchinson TA, Lane DA. Assessing methods for causality assessment of suspected adverse drug reactions. J Clin Epidemiol 1989; 42 (1): 5-16
171. Mann RD. Prescription-event monitoring: recent progress and future horizons. Br J Clin Pharmacol 1998; 46 (3): 195-201
172. Shakir SAW. PEM in the UK. In: Mann RD, Andrews E, editors. Pharmacovigilance. Chichester, UK: John Wiley & Sons Ltd, 2002