Worldwide Regulations for Manufacturers on Clinical Safety Surveillance of Drugs

Gordon, Arnold J.; Petrick, Robert J.

doi:10.1177/009286159202600101

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1992

2018

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Cited by 10 publications

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“…Spain has set some strict guidelines for the industry (Editorial 1990). In Italy, companies can no longer conduct PMS studies unless specifically agreed to by the Ministry of Health; such studies must be carried out by public hospitals or institutions (Gordon & Petrick 1992). The American Society for Clinical Pharmacology and Therapeutics (ASCPT) has produced strict guidelines for its members (ASCPT 1991).…”

Section: The Futurementioning

confidence: 99%

Marketing Aspects of Company-Sponsored Postmarketing Surveillance Studies

Stephens

1993

Drug Safety

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Section: The Futurementioning

confidence: 99%

Marketing Aspects of Company-Sponsored Postmarketing Surveillance Studies

Stephens

1993

Drug Safety

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Causality assessment of suspected adverse drug reactions: A transatlantic view

Jones

1992

Pharmacoepidemiology and Drug

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The European Community's (EC) pending requirement for a standard assessment of the causal association between a drug product and a reported drug‐associated event prompts a review of this aspect of pharmaceutical safety evaluation. Pharmaceutical manufacturers who use various methods, or no methods, may need to consider these EC definitions and their interpretation for evaluating their current procedures and planning any future changes. This paper first describes the EC classifications and their basis as one statement on the status of causality assessment in Europe. Reflecting the rather different view of causality assessment in North America, this paper then briefly reviews the evolution and uses of causality assessment over the last two decades. The controversies over causality are next discussed, followed by examination of the diverse uses of assessment by a pharmaceutical manufacturer or a regulator. Finally, the paper concludes with thoughts on applying causality concepts as tools for enhancing drug‐risk assessment.

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