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KMID : 1142220140090020103
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.103 ~ p.109
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Study on the Assessment of Dependence Potential of Central Nervous System Acting Drugs
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Cha Hye-Jin
Do Won-Im
Ahn Joon-Ik
Sin Ji-Soon
Kang Ho-Il
Kim Young-Hoon
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Abstract
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Recently, several cases related with psychoactive drug abuse/misuse have been reported in Korean society. There is ‘Guideline for non-clinical evaluation of drug dependence’ presented by MFDS to prevent drug abuse through helping pharmaceutical manufacturers set a dependence evaluation system. However, since the guideline was established in 2008, it doesn't only reflect state-of-art technique in dependence evaluation, but also provide evaluating methods in detail. In these regards, an professional working group was set up, in which guidelines abroad were searched and compared with Korean regulations. By operating the working group, a draft on a ‘Guidance for dependence evaluation’ was suggested. Based on the suggestion, NIFDS/MFDS presented a draft version of ‘Guidelines for non-clinical evaluation of drug dependence’. The draft contains specified information on recent methods for dependence evaluation which are necessary for clinical trials and drug approvals from the beginning of submitting documents to MFDS. Also, the experimental methods for dependence evaluation were produced in streaming videos and distributed to whom are needed for better understanding. The draft and the guidances suggested by the present study are believed to be harmonized with global trends, and expected to be in great use to pharmaceutical companies for development of new drug in Korea.
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KEYWORD
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dependence, central nervous system, guideline, guidance, non-clinical evaluation
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