Safety pharmacology - A critical perspective

Drug Development Research

Volumn 41, Issue 2, 1997, Pages 51-57

  Porsolt, Roger D ^a  

^a ITEM Labo   (France)

Author keywords

Ethics; GLP; Guidelines; New drugs; Regulatory requirements; Risk assessment

Indexed keywords

NEW DRUG;

COGNITION; DRUG ABUSE; DRUG EFFECT; DRUG LEGISLATION; DRUG SAFETY; EXPERIMENTAL ANIMAL; GOOD LABORATORY PRACTICE; MEDICAL ETHICS; NONHUMAN; REVIEW; RISK ASSESSMENT; STANDARD;

EID: 0031418286     PISSN: 02724391     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1098-2299(199706)41:2<51::AID-DDR1>3.0.CO;2-Q     Document Type: Review

References (12)

1. Anon (1994): Safety Pharmacology Studies in Medicinal Product Development. Draft 4. Note for Guidance 111/480/87.
2. Anon (1995a): Japanese Guidelines for Nonclinical Studies of Drugs Manual, Pharmaceutical Affairs Bureau, Japanese Ministry of Health and Welfare, Yakugi Nippo.
3. Anon (1995b): Federation of European Research Quality Assurance Societies (FERQAS) Consensus Document Following the Roundtable Discussion at the FERQAS Workshop on GLP and Safety Pharmacology, 3rd Draft.
4. Bigelow GE (1991): Draft Guidelines for Abuse Liability Assessment. Drug Abuse Advisory Committee, FDA, US Public Health Service.
5. Fossa AA (1994): Inaugural conference on general pharmacology/safety pharmacology. Drug Dev Res 32(4).
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7. Kinter LB, Gossett KA, Kerns WD (1994): Status of safety pharmacology in the pharmaceutical industry. Drug Dev Res 32:208-216.
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9. Proakis AG (1994): Regulatory considerations on the role of general pharmacology studies in the development of therapeutic agents. Drug Dev Res 32:23:3-236.
10. Sullivan AT (1994): Present Testing Strategy - An Industry View. Proceedings of Workshop on Use of Pharmacology Studies in Drug Safety Assessments - Present Situation and Future Pespectives, Stockholm, pp 3-8.
11. Sullivan AT (1995): Good laboratory practices and other regulatory issues: A European view. Drug Dev Res 35:145-149.
12. Sullivan AT, Kinter LB (1995): Status of safety pharmacology in the pharmaceutical industry - 1995. Drug Dev Res 35:166-172.