신약개발과 안전성약리시험 가이드라인

• 영문명: Drug Development and Guideline for Safety Pharmacology Studies
• 발행기관: 대한약학회
• 저자명: 최기환(Ki Hwan Choi) 박인숙(In Sook Park) 임화경(Hwa Kyung Lim) 오우용(Woo Yong Oh) 왕소영(So Young Wang) 김소희(So Hee Kim) 김주일(Joo Il Kim) 김동섭(Dong Sup Kim)
• 간행물 정보: 『약학회지』제47권 제2호 (2003년), 104~109쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2003.04.30

영문 초록

The present paper reviews the notion and comparison of the Korea Food and Drug Administration(KFDA) general pharmacology and the International Conference on Harmonisation (ICH) safety pharmacology. General pharmacology or safety pharmacology is termed the study to determine the potential of a compound to induce adverse pharmacological effects. KFDA general pharmacology studies have been considered an important component in drug safety assessment and these were originally referred to those designed to examine effects other than the primary therapeutics effect of a drug candidate. The KFDA notified the Guideline for General Pharmacology in 1997. Safety pharmacology studies were focused on identifying adverse effects on physiological functions. In the ICH came into place S7A Safety Pharmacology Studies for Human Pharmaceuticals in 2001. A new chemical entity should be assessed for its side effects, initially in those physiological systems which are generally agreed to be the key systems that are essential for life; these "core system" include the central nervous system, cardiovascular system and respiratory system in safety pharmacology studies. These studies should be performed in compliance with Good Laboratory Practice (GLP).

키워드

General pharmacology safety pharmacology GLP.