Relationship between Physicochemical Properties of Medical Supplies and Serious Adverse Drug Reactions Listed in the Package Inserts.
YAKUGAKU ZASSHI-JOURNAL OF THE PHARMACEUTICAL SOCIETY OF JAPAN(2017)
Abstract
We sought to clarify the relationship between the physicochemical properties of each medical supply and serious adverse drug reactions listed in the package inserts, by reviewing new information. We investigated 1) 1078 medicines currently available on the domestic Japanese market by using physicochemical data, such as cLogD, molecular weight (MW), and pK(a) and 2) the serious adverse drug reactions stated in the package inserts and the presence or absence of serious renal and liver disorders, as well as mental, extrapyramidal, and skin disorders. The renal disorders data showed: cLogD < 0, adjusted odds ratio (aOR) =2.00; MW values >= 500, aOR= 2.28; and pK(a)< 7.4, aOR= 1.95-2.06. The liver disorders data showed: pK(a)< 8.4, aOR= 1.83-1.95, and MW values >= 300, aOR = 1.47-1.87. The mental disorders data showed: cLogD >= 0, aOR=2.12, and MW values < 400, aOR=2.46-2.85. The extrapyramidal disorders data showed: pK(a)>= 6.4,aOR=4.50-11.32; cLogD >= 0, aOR=4.71; and MW values < 500, aOR=7.95-15.08. The skin disorders data showed: cLogD < 0, aOR=1.46; MW values >= 500, aOR=1.69; and pK(a)< 6.4, aOR=1.65 or < 7.4-8.4, aOR=1.59. This information will be useful for investigating the relationships between new drugs entering the market and their potential future adverse drug reactions, and for establishing both precautionary and medical observational standards.
MoreTranslated text
Key words
physicochemical property,adverse drug reaction,package insert,molecular weight,partition coefficient,dissociation constant
AI Read Science
Must-Reading Tree
Example
![](https://originalfileserver.aminer.cn/sys/aminer/pubs/mrt_preview.jpeg)
Generate MRT to find the research sequence of this paper
Chat Paper
Summary is being generated by the instructions you defined