대한약학회:학술대회논문집 (Proceedings of the PSK Conference)
- 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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- Pages.35-37
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- 2003
The Process of JP Publication in relation with Drug Regulation in Japan and International Harmonization
초록
Efficacy and safety of drugs are evaluated in the process of drug registration along with the basis of setting test method and acceptance criteria for assuring quality of the drugs. Quality of drugs plays a key role to guarantee the efficacy and safety of drugs approved in the evaluation process at the marketing stage after approval. Most important role of pharmacopoeia is to give the basis of assuring the quality of drugs. (omitted)
키워드