Safety pharmacology - A progressive approach

Fundamental and Clinical Pharmacology

Volumn 16, Issue 3, 2002, Pages 161-173

  Redfern, William S ^a   Wakefield, Ian D ^a   Prior, Helen ^a   Pollard, Christopher E ^a   Hammond, Timothy G ^a   Valentin, Jean Pierre ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Adverse drug reactions; CPMP; Forsades de pointes; ICH; Safety pharmacology

Indexed keywords

CISAPRIDE; CLONIDINE; PROPRANOLOL;

ARTICLE; BRONCHOSPASM; CAUSE OF DEATH; CLINICAL TRIAL; DECISION MAKING; DRUG EFFECT; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; FOLLOW UP; HUMAN; MEDICAL INFORMATION; NONHUMAN; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; PUBLICATION; QT INTERVAL; RELIABILITY; RISK ASSESSMENT; RUGBY; SEDATION; SIGNAL NOISE RATIO; TORSADE DES POINTES; UNITED STATES; VALIDATION PROCESS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; CLINICAL TRIALS; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOLOGY, CLINICAL; PRACTICE GUIDELINES; RESEARCH DESIGN; RISK ASSESSMENT; SAFETY;

EID: 0036417847     PISSN: 07673981     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1472-8206.2002.00098.x     Document Type: Article

References (56)

1. Anonymous. Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals, US FDA, ICH, town, USA, July 2001.
2. Anonymous. Japanese Guidelines for Nonclinical Studies of Drugs Manual. Pharmaceutical Affairs Bureau. Japanese Ministry of Health and Welfare, Yakugi Nippo, Japan, 1995.
3. Lumley C.E. General pharmacology, the international regulatory environment, and harmonization of guidelines. Drug Dev. Res. (1994) 32 223-232.
4. Sullivan A.T. Good laboratory practice and other regulatory issues: A European view. Drug Dev. Res. (1995) 35 145-149.
5. Christian M.S. Good laboratory practices and other regulatory issues: A Regulatory Affairs view. Drug Dev. Res. (1995) 35 161-165.
6. Williams P.D. The role of pharmacological profiling in safety assesment. Reg. Toxicol. Pharmacol. (1990) 12 238-252.
7. Kinter L.B. General pharmacology/safety pharmacology: Customers, biologies and GLPs. Drug Dev. Res. (1995) 35 142-144.
8. Sullivan A.T., Kinter L.B. Status of safety pharmacology in the pharmaceutical industry - 1995. Drug Dev. Res. (1995) 35 166-172.
9. Kinter L.B., Dixon L.W. Safety pharmacology program for pharmaceuticals. Drug Dev. Res. (1995) 35 179-182.
10. Porsolt R.D. Safety pharmacology - A critical perspective. Drug Dev. Res. (1997) 41 51-57.
11. Committee for Proprietary Medicinal Products. Points to Consider. The Assessment of QT Interval Prolongation by Non-cardiovascular Medicinal Products. CPMP/986/96, 1997.
12. Russel W.M.S., Burch R.L. The Principles of Humane Experimental Technique. Methuen, London (1959), reprinted by Universities Federation for Animal Welfare, Potters Bar, UK, 1992.
13. Igarashi T., Nakane S., Kitagawa T. Predictability of clinical adverse reactions of drugs by general pharmacology studies. J. Toxicol. Sci. (1995) 20 77-92.
14. Laurence D.R., Bennett P.N. Clinical Pharmacology. Churchill Livingstone, Edinburgh, 1992, pp. 121-122.
15. Zarafonetis C. J., Riley P.A., Willis P.W. et al. Clin. Pharmacol. Ther. (1978) 24 127-132.
16. Kolata G.B. The death of a research subject. The Hastings Center Report (1980) 10 5-6.
17. Darragh A., Kenny M., Lambe R., Brick I. Sudden death of a volunteer. Lancet (1985) I 93-94.
18. Editorial. Death of a volunteer. Br. Med. J. (1985) 290 1369-1370.
19. Orme M., Harry J., Routledge P., Hobson S. Healthy volunteer studies in Great Britain: The results of a survey into 12 months activity in this field. Br. J. Clin. Pharmacol. (1989) 27 125-133.
20. Sibille M., Deigat N., Jamin A., Kirkesseli S., Vital Durand D. Adverse events in phase-I studies: A report in 1015 healthy volunteers. Eur. J. Clin. Pharmacol. (1998) 54 13-20.
21. McCarthy M. Healthy volunteer dies in US physiology study. Lancet (2001) 357 2114.
22. Lazarou J., Pomeranz B.H., Corey P.N. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA (1998) 279 1200-1205.
23. Maurissen J.P.J. Neurobehavioral methods for the evaluation of sensory functions, in: Chang L.W., Slikker W., eds, Neurotoxicology: Approaches and Methods. Academic Press, San Diego, 1995, pp. 239-264.
24. Sahgal A., ed. Behavioural Neuroscience - A Practical Approach, Vol. II. Oxford University Press, Oxford, UK, 1993.
25. Kelley A.E. Locomotor activity and exploration, in: Sahgal A., ed. Behavioural Neuroscience - A Practical Approach, Vol. II, Oxford University Press, Oxford, 1993, pp. 1-21.
26. Chen Y.J., Hsieh M.H., Chiou C.W., Chen S.A. Electropharmacologic characteristics of ventricular proarrhythmia induced by ibutilide. J. Cardiovasc. Pharmacol. (1999) 34 237-247.
27. Hammond T.G., Carlsson L., Davis A.S. et al. Methods of collecting and evaluating non-clinical cardiac electrophysiology data in the pharmaceutical industry: Results of an international survey. Cardiovasc. Res. (2001) 49 741-750.
28. Frith C.D., McGinty M.A., Gergel I., Crow T.J. The effects of scopolamine and clonidine upon the performance and learning of a motor skill. Psycopharmacol. (1989) 98 120-125.
29. Laverty R., Taylor K.M. Behavioural and biochemical effects of 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride (St 155) on the central nervous system. Br. J. Pharmacol. (1969) 35 253-264.
30. Hoefke A., Kobinger W., Walland A. Relationship between activity and structure in derivatives of clonidine. Arzneim. Forsch. (1975) 25 786-793.
31. Clough D.P., Hatton R., Pettinger S.J. A new centrally acting antihypertensive (ICI 106270) which separates antihypertensive effects from sedation. Arneim. Forsch. (1981) 31 1698-1703.
32. Skingle M., Hayes A.G., Tyers M.B. Antinociceptive activity of clonidine in the mouse, rat and dog. Life Sci. (1982) 31 1123-1132.
33. Butelman E.R., Woods J.H. Effects of clonidine, dexmedetomidine and xylazine on thermal antinociception in rhesus monkeys. J. Pharmacol. Exp. Ther. (1993) 264 762-769.
34. Weerts E.M., Griffiths R.R. Evaluation of the intravenous reinforcing effects of clonidine in baboons. Drug Alcohol Dependence (1999) 53 207-214.
35. Reid J.L., Barber N.D., Davies D.S. The clinical pharmacology of clonidine: Relationship between plasma concentration and pharmacological effect in animals and man. Arch. Int. Pharmacodynam. Ther. (1980) (Suppl.) 11-16.
36. Rampe D., Roy M.L., Dennis A., Brown A.M. A mechanism for the proarrhythmic effects of cisapride (Propulsid): High affinity blockade of the human cardiac potassium channel HERG. FEBS Lett. (1997) 417 28-32.
37. + channel by the gastrointestinal prokinetic agent cisapride. Am. J. Physiol. (1997) 273 H2534-H2538.
38. Walker B.D., Singleton C.B., Bursill J.A. et al. Inhibition of the human ether-a-go-go-related gene (HERG) potassium channel by cisapride: Affinity for open and inactivated states. Br. J. Pharmacol. (1999) 128 444-450.
39. Puisieux F.L., Adamantadis M.M., Dumotier B.M., Dupuis B.A. Cisapride-induced prolongation of cardiac action potential and early afterdepolarizations in rabbit Purkinje fibres. Br. J. Pharmacol. (1996) 117 1377-1379.
40. Carlsson L., Amos G.J., Andersson B., Drews L., Duker G., Wadstedt G. Electrophysiological characterization of the prokinetic agents cisapride and mosapride in vivo and in vitro: Implications for proarrhythmia potential? J. Pharmacol. Exp. Ther. (1997) 282 220-227.
41. Kii Y., Ito T. Effects of the 5-HT4- receptor agonists, cisapride, mosapride citrate, and zacopride, on cardiac action potentials in guinea pig isolated papillary muscles. J. Cardiovasc. Pharmacol. (1997) 29 670-675.
42. Drici M.D., Ebert S.N., Wang W.X. et al. Comparison of tegaserod (HTF 919) and its main human metabolite with cisapride and erythromycin on cardiac repolarization in the isolated rabbit heart. J. Cardiovasc. Pharmacol. (1999) 34 82-88.
43. Chen Y.J., Lee S.H., Hsieh M.H., et al. Effects of 17β-estradiol on tachycardia-induced changes of atrial refractoriness and cisapride-induced ventricular arrhythmia. J. Cardiovasc. Electrophysiol. (1999) 10 587-598.
44. van Haarst A.D., van't Klooster G.A., van Gerven J.M. et al. The influence of cisapride and clarithromycin on QT intervals in healthy volunteers. Clin. Pharmacol. Ther. (1998) 64 542-546.
45. MacLagan J., Ney U.M. A comparison of the bronchoconstrictor and β-adrenoceptor blocking activity of propranolol and acebutolol. Br. J. Pharmacol. (1980) 68 196-198.
46. Tomioka, K., Yamada, T., Takenada, T. Comparison of airway obstruction induced by propranolol and YM-09538 (a combined α- and β-adrenoceptor blocking drug). Arch. Int. Pharmacodynam. Ther. (1982) 256 97-107.
47. Tattersfield A.E. β-adrenoceptor antagonists and respiratory disease. J. Cardiovasc. Pharmacol. (1986) 8 35-39.
48. McNeill R.S. Effect of a β-adrenergic-blocking agent, propranolol, on asthmatics. Lancet (1964) ii 1101-1102.
49. Zbinden G. Neglect of function and obsession with structure in toxicity testing, in: Proceedings of the 9th Int. Congr. Pharmacol Vol. 1, Macmillan, New York, 1984, pp. 43-49.
50. Zbinden G. Predictive value of animal studies in toxicology. Reg. Toxicol. Pharmacol. (1991) 14 167-177.
51. MacPhail R.C., Tilson H.A. Behavioral screening tests: Past, present and future, in: Chang, L.W., Slikker, W., eds, Neurotoxicology: Approaches and Methods. Academic Press, San Diego, USA, 1995, pp. 231-238.
52. Goldstein A., Aronow L., Kalman S.M. Principles of Drug Action, 2nd Edn., Wiley, New York, USA, pp. 569-621.
53. Haefely W. Biological basis of drug-induced tolerance, rebound and dependence. Contribution of recent research on benzodiazepines. Pharmacopsychiatry (1986) 19 353-361.
54. Wakefield I.D., Pollard C., Redfern W.S., Hammond T.G., Valentin J.-P. The applications of in vitro methods to safety pharmacology. Fundam. Clin. Pharmacol. (2002) 16 209-218.
55. Mitcheson J.S., Chen J., Lin M., Culberson C., Sanguinetti M.C. A structural basis for drug-induced long QT syndrome. Proc. Natl. Acad. Sci. USA (2000) 97 12329-12333.
56. Noble D., Levin J., Scott W. Biological simulations in drug discovery. Drug Discovery Today (1999) 4 10-16.