バイオテクノロジー応用医薬品の添付文書における日米間の相違

概要

論文の詳細を見る
The differences between the usage directions (storage, preparation and administration) found in the package inserts of Japanese and American biotechnological drugs were examined. In general. American description were found to provide more detailed information on all issues, especially aggregate formation due to the nature of protein molecules. Aggregation was caused by excessive agitation of interferon α 2a, dilution with saline of filgrastim and unusual handling of insulin. These drugs should be carefully checked for the aggregates formed, which might exhibit immuno- or neurotoxic properties. The insufficient information provided on the usage of the biotechnological drugs in Japan should be reconsidered, and pharmacists must take the responsibility for ensuring the proper use of drugs until just before administration.
日本医療薬学会の論文
1995-02-10