Sentence examples for premarket evaluation from inspiring English sources

The purpose of this study is to investigate methods of evaluating therapeutic parameters used in the premarket evaluation of photodynamic therapy (PDT) drugs that have previously been approved in Japan and the United States, in order to establish a methodology that allows optimization of the therapeutic parameters of PDT, and to analyze current issues.

Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan.

The current paradigm for premarket evaluation of cardiac safety begins with preclinical animal modeling and progresses to clinical biomarker or biosignature assays.

In this premarket evaluation, discordant specimens were further examined by repeat Western blot testing.

The FDA has issued a new guidance in January 2013 on the premarket evaluation of clinical pharmacogenomics during early-phase clinical studies [ 9].

Although herbal product usage continues to increase, current regulatory guidelines in several Western countries do not request premarket evaluation of herb drug interaction liability.

The electrosurgical knives required to perform endoscopic submucosal dissection (ESD) have recently passed the 510(k) premarketing evaluation by the U.S. Food and Drug Administration and are now available for purchase in the United States.

The listed strata of study subjects without pre-existing liver abnormalities primarily follow the FDA guidance on drug-induced liver injury: premarketing evaluation (2009) [ 8] cPre-treatment test results of individual study subjects.

It is worth noting that none of the subjects with increases in hepatic biochemistry parameters met the criterion defined in the FDA Guidance for premarketing evaluation of drug-induced liver injury for severe liver damage (Hy's law) (6).

None of the elevations in liver aminotransferases fulfilled Hy's law criteria for drug-induced liver injury as defined in the U.S. Food and Drug Administration FDAA) Guidance on the Premarketing Evaluation of Drug-induced Liver Injury, 9 because all values of serum bilirubin determined during the treatment period remained within the normal range.

However, clinicians need to be aware that, unlike drugs, these probiotic dietary supplements are not required by FDA to undergo rigorous premarketing evaluations for efficacy or safety.