Journal of Diabetes Medication & Care

Drug Safety New Findings

 The subject of drug safety can be divided into a handful of topics. The topic of medical manifestations of opposing events is readily appreciated by any layperson, as these often comprise nausea, vomiting, and low blood cell counts. The topic of characterizations is more subtle, as these definitions imitate definitions set forth by regulatory agencies. In addition to definitions, contrary events can fall into other categories, such as classifications created by statisticians, for example ITT analysis vs. PP analysis of adverse events, categories requiring clinical judgment, and categories necessitating a knowledge of pharmacology and biochemistry. The above-mentioned topics are a essential for understanding the following topics, that is, the issues of data management and process in clinical trials, as it applies to drug safety.  

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