Place and role of safety pharmacology in drug development;Place et rôle de la pharmacologie de sécurité dans le développement des médicaments

Annales Pharmaceutiques Francaises

Volumn 68, Issue 5, 2010, Pages 291-300

  Guillon, J M ^a  

^a SANOFI   (France)

Author keywords

Adverse effects; ICH; Safety pharmacology; Unwanted effects

Indexed keywords

ANALGESIC AGENT; ANTIDEPRESSANT AGENT; ANTIHISTAMINIC AGENT; ANTITUSSIVE AGENT; ANXIOLYTIC AGENT; CENTRAL STIMULANT AGENT; DECONGESTIVE AGENT; HYPNOTIC AGENT; OPIATE DERIVATIVE; THIORIDAZINE;

BEHAVIOR; BLOOD PRESSURE; BODY TEMPERATURE; CARDIOVASCULAR EFFECT; CENTRAL NERVOUS SYSTEM FUNCTION; DRUG ABUSE; DRUG DEVELOPMENT; DRUG EFFECT; DRUG OVERDOSE; DRUG SAFETY; ELECTROCARDIOGRAPHY; GOOD LABORATORY PRACTICE; HEART ARRHYTHMIA; HEART REPOLARIZATION; HUMAN; MOTOR ACTIVITY; NONHUMAN; REFLEX; RESPIRATORY FUNCTION; REVIEW; RISK BENEFIT ANALYSIS; TORSADE DES POINTES;

EID: 77956613247     PISSN: 00034509     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.pharma.2010.05.005     Document Type: Review

References (32)

1. Japanese guidelines for non clinical studies of drugs manual. Tokyo: Yakuji Nippo; 1995.
2. ICH M3. Nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals CPMP/ICH/288/95 1997.
3. ICHS7A. Note for guidance on safety pharmacology studies for human pharmaceuticals CPMP/ICH/539/00 2000.
4. Bonnes pratiques de laboratoire, arrêté ministériel du 14 mars, ministère du Travail, de l'Emploi et de la Solidarité.
5. ICHS7B. The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals CHMP/ICH/423/02 2005.
6. EMEA/CHMP/SWP/94227/2004. Guideline of the non-clinical investigation of the dependence potential of medicinal products. , 2006, 1-12. http://www.emea.eu.int/.
7. Irwin S. Comprehensive behavioural assessment: a systematic quantitative procedure for assessing the behavioural and physiologic state of the mouse. Psychopharmacologia 1968, 13:22-257.
8. Mattson J.L., Spencer P.J., Albee R.R. A performance standard for clinical and functional observational battery examination of rats. J Am Coll Toxicol 1996, 15:239-250.
9. Reiter L.R., McPhail R.C. Motor activity: a survey of methods with potential use in toxicity testing. Neurobehav Toxicol 1979, 1:53-66.
10. Dunham N.W., Miya T.S. A note on a simple apparatus for detecting neurological deficit in mice and rat. J Am Pharm Assoc 1957, 46:208-209.
11. Drug dependency test, drug approval and licensing procedures in Japan - 1997, Yakugyo Jiho Guideline Japan notification no. 113. of the Narcotics Division, PAB dated March 14, 1975 and for complement notification no. 383 of the Narcotics Division, PAB dated June 7, 1978.
12. FDA, Center for drug evaluation and research, division of drugs information. Assessment of abuse potential of drugs, January 2010.
13. Gianutsos G., Drawbaugh R., Hynes M., Lal H. The narcotic withdrawal syndrome in the rat. Methods in narcotic research. 1975, 293-309. Marcel Dekker, New York.
14. Tzschentke T. Measuring reward with the conditioned preference paradigm: a comprehensive review of drug effects, recent progress and new issues. Prog Neurobiol 1998, 56:613-672.
15. Colpaert F.C. Drug discrimination in neurobiology. Pharmacol Biochem Behav 1999, 64:337-345.
16. Ator N.A., Griffiths R.R. Principles of drug abuse liability assessment in laboratory animals. Drug Alcohol Depend 2003, 70:S55-S72.
17. Monahan B.P., Ferguson C.L., Kileavy E.S., Llyod B.K., Try J., Cantilena L.R. Torsades de pointes occurring in association with terfenadine use. JAMA 1990, 264:2788-2790.
18. Zimmerman M., Duruz H., Guinand O., Broccard O., Levy P., Lactis D., et al. Torsades de pointes after treatment with terfenadine and ketoconazole. Eur Heart J 1992, 13:1002-1003.
19. Redfern W.S., Carlsson L., Davis A.S., Lynch W.G., MacKenzie I., Palethorpe S., et al. Relationship between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development. Cardiovasc Res 2003, 58:32-45.
20. Dessertenne F. La tachycardie ventriculaire à deux foyers opposés variables. Arch Mal Cœur Vaiss 1966, 59:263-272.
21. Roden D.N., Viswanathan P.C. Genetics of acquired long QT syndrome. J Clin Invest 2005, 115:2025-2032.
22. Cavero I., Mestre M., Guillon J.M., Crumb W. Drugs that prolong QT interval as an unwanted effect: assessing their likelihood of inducing hazardous cardiac dysrhythmias. Expert Opin Pharmacother 2000, 1:947-973.
23. Lundblad L.K.A., Irwin C.G., Adler A., Bates J.H.T. A reevaluation of the validity of unrestrained plethysmography in mice. J Appl Physiol 2002, 93:1198-1207.
24. Withebread S., Hamon J., Bojanovic D., Urban L. In vitro safety pharmacology profiling: an essential tool for successful drug development. Drug Discov Today 2005, 10:1421-1433.
25. Netzer R., Bischoff U., Ebneth A. HTS techniques to investigate the potential effects of compounds on cardiac ion channels at early-stages of drug discovery. Curr Opin Drug Discov Devel 2003, 6(4):462-469.
26. Briggs J.P. The zebrafish: a new model organism for integrative physiology. AJP-Regulatory Integrative Comp Physiol 2002, 282:R3-R9.
27. Mittelstadt S.W., Hemenway C.L., Craig M.P., Hove J.R. Evaluation of zebrafish embryos as a model for assessing inhibition of hERG. J Pharmacol Toxicol Meth 2008, 57:100-105.
28. Ekins S. Predicting undesirable drug interactions with promiscuous proteins in silico. Drug Discov Today 2004, 9:276-285.
29. Sesti F., Abbott G.W., Wei J., Murray K.T., SaksenaA, Schwartz P.J., et al. A common polymorphism associated with antibiotic-induced arrhythmia. PNAS 2000, 97:10613-10618.
30. Clewell R.A., Clewell H.J. Development and specification of physiologically based pharmacokinetic models for use in risk assessment. Regul Toxicol Pharmacol 2008, 50:129-143.
31. Baumann A. Preclinical development of therapeutic biologics. Expert Opin Drug Discov 2008, 3:289-297.
32. Cohen A. Should we tolerate tolerability as an objective in early drug development?. Br J Clin Pharmacol 2007, 64:249-252.