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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/17017

Title: Comparative study of Saudi-marketed products and US drug labeling.
Authors: Bawazir SA
al-Hassan MI
al-Khamis KI
Abou-Auda HS
Issue Date: 1991
Publisher: LANL
Abstract: Drug package inserts from ten nonsteroidal antiinflammatory drugs marketed in Saudi Arabia were compared with their corresponding US labels to determine possible differences in their information content. These variations were assessed with special regard to the number of words used and the type of the information provided. The study showed that inserts of Saudi-marketed products generally conveyed limited and incomplete information. Possible adverse reactions, drug--drug interactions, and date of revision often were not included, although this information was present on the corresponding US labels. Comparisons of the package inserts of the same product from various pharmaceutical companies show wide variations in the amount of information provided. Determining the minimal level of information that must be included by the manufacturer in the package insert and the establishment of firm international guidelines by the World Health Organization could effectively reduce such variations.
URI: http://hdl.handle.net/123456789/17017
Appears in Collections:College of Pharmacy

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