예방용 DNA 백신 평가 가이드라인
Guideline on Evaluation of Prophylactic DNA Vaccines
목 차
용어설명···················································································································6
1. 서론······················································································································9
1.1. 배경················································································································9
1.2. 목적 및 범위································································································5
1.3. 일반적 고려사항························································································16
2. 품질 평가··········································································································18
2.1. 정의··············································································································18
2.2. 제조의 일반적 사항··················································································18
2.3. 원액의 제조 및 관리················································································20
2.4. 완제의약품의 제조 및 관리····································································27
3. 비임상 평가······································································································34
4. 임상 평가··········································································································37
출처: 식품의약품안전처
예방용 DNA 백신 평가 가이드라인
Guideline on Evaluation of Prophylactic DNA Vaccines
목 차
용어설명···················································································································6
1. 서론······················································································································9
1.1. 배경················································································································9
1.2. 목적 및 범위································································································5
1.3. 일반적 고려사항························································································16
2. 품질 평가··········································································································18
2.1. 정의··············································································································18
2.2. 제조의 일반적 사항··················································································18
2.3. 원액의 제조 및 관리················································································20
2.4. 완제의약품의 제조 및 관리····································································27
3. 비임상 평가······································································································34
4. 임상 평가··········································································································37
출처: 식품의약품안전처
예방용+DNA+백신+평가+가이드라인.pdf