Proceedings of the PSK Conference (대한약학회:학술대회논문집)
- 2003.04a
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- Pages.291.1-291.1
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- 2003
Guidance for the Evaluation Method of Drugs of Abused in vitro Diagnostic Devices
- Kang, Shin-Jung (Korea Food and Drug Administration) ;
- Choi, Hyun-Ceol (Korea Food and Drug Administratio) ;
- Kim, Ho-Jeong (Korea Food and Drug Administratio) ;
- Park, Sang-Aeh (Korea Food and Drug Administratio) ;
- Chug, Hee-Sun (Korea Food and Drug Administration)
- Published : 2003.04.01
Abstract
The purpose of this study is to provide KFDA's guidance for premarket notification submission and labeling for prescription use drugs of abuse in vitro diagnostic devices. To evaluate in vitro diagnostic devices the following performance characteristics should be described in detail within the submission: analytical sensitivity or minimum detection limit, cutoff concentration, specificity and cross reactivity, interference, precision, method comparison and stability. (omitted)
Keywords