일본뇌염 백신의 안전성·유효성 평가 가이드라인
이 안내서는 일본뇌염 백신의 안전성·유효성 평가 시 고려사항에 대하여 알기 쉽게 설명하거나 식품의약품안전처의 입장을 기술한 것입니다.
본 안내서는 대외적으로 법적 효력을 가지는 것이 아니므로 본문의 기술방식(‘∼하여야 한다’ 등)에도 불구하고 참고로만 활용하시기 바랍니다.
또한, 본 안내서는 2021년 10월 현재의 과학적ㆍ기술적 사실 및 유효한 법규를 토대로 작성되었으므로 이후 최신 개정 법규 내용 및 구체적인 사실관계 등에 따라 달리 적용될 수 있음을 알려드립니다.
목 차
Ⅰ. 서론 ····················································································································· 1
Ⅱ. 적용범위 ············································································································· 7
Ⅲ. 용어정의 ············································································································· 9
Ⅳ. 일본뇌염 불활화 백신에 대한 비임상시험 고려사항 ··························· 12
1. 면역원성 연구 ···························································································· 12
2. 능동적 방어연구 ························································································ 12
3. 수동적 방어연구 ························································································ 13
4. 독성연구 ······································································································ 13
Ⅴ. 일본뇌염 약독화 생백신에 대한 비임상시험 고려사항 ························· 14
1. 제품 특성분석 및 공정 개발 ··································································· 14
2. 비임상 면역원성 및 방어효과 ································································· 15
3. 비임상 독성 및 안전성 ············································································· 16
Ⅵ. 일본뇌염 백신의 임상시험 고려사항 ························································· 22
1. 일반 고려사항 ···························································································· 22
2. 면역원성 평가 ······························································································ 22
2.1 면역 반응 평가 ······················································································· 22
2.2 평가변수 및 분석 ··················································································· 23
2.3 용량 및 투여계획 ····················································································· 25
2.4 비교 면역원성 연구 ················································································· 26
2.5 백신 병용 투여 ························································································· 27
3. 안전성 ·········································································································· 27
4. 품목허가 후 연구 ······················································································· 29
부록1. ·················································································································· 31
부록2. ·················································································································· 34
Ⅶ. 참고문헌 ········································································································· 40
출처: 식품의약품안전처
일본뇌염 백신의 안전성·유효성 평가 가이드라인
이 안내서는 일본뇌염 백신의 안전성·유효성 평가 시 고려사항에 대하여 알기 쉽게 설명하거나 식품의약품안전처의 입장을 기술한 것입니다.
본 안내서는 대외적으로 법적 효력을 가지는 것이 아니므로 본문의 기술방식(‘∼하여야 한다’ 등)에도 불구하고 참고로만 활용하시기 바랍니다.
또한, 본 안내서는 2021년 10월 현재의 과학적ㆍ기술적 사실 및 유효한 법규를 토대로 작성되었으므로 이후 최신 개정 법규 내용 및 구체적인 사실관계 등에 따라 달리 적용될 수 있음을 알려드립니다.
목 차
Ⅰ. 서론 ····················································································································· 1
Ⅱ. 적용범위 ············································································································· 7
Ⅲ. 용어정의 ············································································································· 9
Ⅳ. 일본뇌염 불활화 백신에 대한 비임상시험 고려사항 ··························· 12
1. 면역원성 연구 ···························································································· 12
2. 능동적 방어연구 ························································································ 12
3. 수동적 방어연구 ························································································ 13
4. 독성연구 ······································································································ 13
Ⅴ. 일본뇌염 약독화 생백신에 대한 비임상시험 고려사항 ························· 14
1. 제품 특성분석 및 공정 개발 ··································································· 14
2. 비임상 면역원성 및 방어효과 ································································· 15
3. 비임상 독성 및 안전성 ············································································· 16
Ⅵ. 일본뇌염 백신의 임상시험 고려사항 ························································· 22
1. 일반 고려사항 ···························································································· 22
2. 면역원성 평가 ······························································································ 22
2.1 면역 반응 평가 ······················································································· 22
2.2 평가변수 및 분석 ··················································································· 23
2.3 용량 및 투여계획 ····················································································· 25
2.4 비교 면역원성 연구 ················································································· 26
2.5 백신 병용 투여 ························································································· 27
3. 안전성 ·········································································································· 27
4. 품목허가 후 연구 ······················································································· 29
부록1. ·················································································································· 31
부록2. ·················································································································· 34
Ⅶ. 참고문헌 ········································································································· 40
출처: 식품의약품안전처