머리말 ················································································································1
II. 신약 및 자료제출의약품 ······································································2
1. 임상약리시험 (PHASE I) ·········································································2
가. 원료의약품 (DRUG SUBSTANCE)
1) 일반정보 (General Information) ······························································2
2) 제조원 (Manufacturer(s)) ··········································································3
3) 제조공정 및 공정관리 (Description of Manufacturing Process and
Process Controls) ·····························································································3
4) 불순물 (Impurities) ·····················································································3
5) 규격 (Specification) ····················································································3
6) 시험방법 (Analytical Procedures) ····························································4
7) 시험방법의 밸리데이션 (Validation of Analytical Procedures) ·········4
8) 배치분석 (Batch Analyses) ·······································································4
9) 표준품 또는 표준물질 (Reference Standard or Materials) ··············· 4
10) 용기 및 포장 (Container Closure System) ········································4
11) 안정성 (Stability) ························································································4
나. 임상시험용의약품 (INVESTIGATIONAL MEDICINAL PRODUCTS)
1) 임상시험용의약품의 개요와 조성 (Description and Composition of the
Investigational Medicinal Product) ······························································5
2) 제조원 (Manufacturer(s)) ··········································································5
3) 제조공정 및 공정관리 (Description of Manufacturing Process
and Process Controls) ·····················································································5
4) 불순물 (Impurities) ·····················································································5
5) 규격 (Specification) ······················································································5
6) 시험방법 (Analytical Procedures) ····························································6
7) 시험방법의 밸리데이션 (Validation of Analytical Procedures) ·········6
8) 배치분석 (Batch Analyses) ·······································································6
9) 표준품 또는 표준물질 (Reference Standard or Materials) ··············· 6
10) 용기 및 포장 (Container Closure System) ········································6
11) 안정성 (Stability) ························································································6
2. 치료적 탐색 임상시험 (PHASE II) ··················································7
가. 원료의약품
3.2.S 원료의약품 (DRUG SUBSTANCE)
3.2.S.1 일반정보 (General Information) ······················································7
3.2.S.1.1 명칭 (Nomenclature) ·······································································7
3.2.S.1.2 구조 (Structure) ·············································································8
3.2.S.1.3 일반적 특성 (General Properties) ············································8
3.2.S.2 제조 (Manufacture) ············································································8
3.2.S.2.1 제조원 (Manufacturer(s)) ·································································8
3.2.S.2.2 제조공정 및 공정관리 (Description of Manufacturing Process
and Process Controls) ·····················································································8
3.2.S.3 특성 (Characterization) ·····································································9
3.2.S.3.1 구조 및 기타 특성 (Elucidation of Structure and other
Characteristics) ·······························································································9
3.2.S.3.2 불순물 (Impurities) ········································································9
3.2.S.4 원료의약품의 관리 (Control of Drug Substance) ························9
3.2.S.4.1 규격 (Specification) ···········································································9
3.2.S.4.2 시험방법 (Analytical Procedures) ··············································9
3.2.S.4.3 시험방법의 밸리데이션 (Validation of Analytical Procedures)
······························································································································9
3.2.S.4.4 배치 분석 (Batch Analyses) ························································9
3.2.S.4.5 기준설정근거 (Justification of Specification) ·····························10
3.2.S.5 표준품 또는 표준물질 (Reference Standards or Materials) ····10
3.2.S.6 용기 및 포장 (Container Closure System) ··································10
3.2.S.7 안정성 (Stability) ··············································································10
3.2.S.7.1 안정성 요약 및 결론 (Stability Summary and Conclusions) ······10
3.2.S.7.3 안정성자료 (Stability Data) ·······················································10
나. 임상시험용의약품
3.2.P 임상시험용의약품 (INVESTIGATIONAL MEDICINAL PRODUCTS)
3.2.P.1 임상시험용의약품의 개요와 조성 (Description and Composition
of the Investigational Medicinal Product) ················································11
3.2.P.2 개발경위 (Pharmaceutical Development) ····································11
3.2.P.3 제조 (Manufacture) ········································································11
3.2.P.3.1 제조원 (Manufacturer(s)) ·····························································11
3.2.P.3.2 배치 조성 (Batch Formular) ·························································11
3.2.P.3.3 제조공정 및 공정관리 (Description of Manufacturing Process
and Process Controls) ···················································································11
3.2.P.4 첨가제 관리 (Control of Excipients) ··············································12
3.2.P.5 임상시험용의약품의 관리 (Control of the Investigational
Medicinal Product) ·······················································································12
3.2.P.5.1 규격 (Specifications) ·······································································12
3.2.P.5.2 시험방법 (Analytical Procedures) ··············································12
3.2.P.5.3 시험방법의 밸리데이션 (Validation of Analytical Procedures) ··· 12
3.2..P.5.4 배치 분석 (Batch Analyses) ·························································13
3.2.P.5.5 불순물의 특성 (Characterization of Impurities) ···················13
3.2.P.5.6 기준설정근거 (Justification of Specification) ····························13
3.2.P.6 표준품 또는 표준물질 (Reference Standards or Materials) · 13
3.2.P.7 용기 및 포장 (Container Closure System) ··································13
3.2.P.8 안정성 (Stability) ················································································13
3.2.P.8.1 안정성요약 및 결론 (Stability Summary and Conclusions) ···· 14
3.2.P.8.3 안정성자료 (Stability Data) ···························································14
다. 위약 ·············································································································14
라. 대조약 ··········································································································14
3. 치료적 확증 임상시험 (PHASE Ⅲ) ···············································15
가. 원료의약품
3.2.S 원료의약품 (DRUG SUBSTANCE)
3.2.S.1 일반정보 (General Information) ····················································15
3.2.S.1.1 명칭 (Nomenclature) ·····································································15
3.2.S.1.2 구조 (Structure) ·············································································15
3.2.S.1.3 일반적 특성 (General Properties) ··············································15
3.2.S.2 제조 (Manufacture) ··········································································15
3.2.S.2.1 제조원 (Manufacturer(s)) ·······························································15
3.2.S.2.2 제조공정 및 공정관리 (Description of Manufacturing Process
and Process Controls) ···················································································15
3.2.S.3 특성 (Characterization) ···································································16
3.2.S.3.1 구조 및 기타 특성 (Elucidation of Structure and other
Characteristics) ·····························································································16
3.2.S.3.2 불순물 (Impurities) ··········································································16
3.2.S.4.1 규격 (Specification) ·········································································16
3.2.S.4.2 시험방법 (Analytical Procedures) ············································16
3.2.S.4.3 시험방법의 밸리데이션 (Validation of Analytical Procedures)
····························································································································17
3.2.S.4.4 배치 분석 (Batch Analyses) ··························································17
3.2.S.4.5 기준설정근거 (Justification of Specification) ·····························17
3.2.S.5 표준품 또는 표준물질 (Reference Standards or Materials) ······17
3.2.S.6 용기 및 포장 (Container Closure System) ··································17
3.2.S.7 안정성 (Stability) ··············································································17
3.2.S.7.1 안정성 요약 및 결론 (Stability Summary and Conclusions) ······17
3.2.S.7.3 안정성자료 (Stability Data) ·························································18
나. 임상시험용의약품
3.2.P 임상시험용의약품 (INVESTIGATIONAL MEDICINAL PRODUCTS)
3.2.P.1 임상시험용의약품의 개요와 조성 (Description and Composition
of the Investigational Medicinal Product) ················································18
3.2.P.2 개발경위 (Pharmaceutical Development) ······································18
3.2.P.3 제조 (Manufacture) ············································································18
3.2.P.3.1 제조원 (Manufacturer(s)) ·····························································18
3.2.P.3.2 배치 조성 (Batch Formular) ·························································19
3.2.P.3.3 제조공정 및 공정관리 (Description of Manufacturing Process
and Process Controls) ···················································································19
3.2.P.4 첨가제 관리 (Control of Excipients) ··············································19
3.2.P.5 임상시험용의약품의 관리 (Control of the Investigational
Medicinal Product) ·······················································································19
3.2.P.5.1 규격 (Specifications) ·······································································19
3.2.P.5.2 시험방법 (Analytical Procedures) ··············································19
3.2.P.5.3 시험방법의 밸리데이션 (Validation of Analytical Procedures) ··· 19
3.2..P.5.4 배치 분석 (Batch Analyses) ·························································20
3.2.P.5.5 불순물의 특성 (Characterization of Impurities) ·····················20
3.2.P.5.6 기준설정근거 (Justification of Specification) ····························20
3.2.P.6 표준품 또는 표준물질 (Reference Standards or Materials) · 20
3.2.P.7 용기 및 포장 (Container Closure System) ··································20
3.2.P.8 안정성 (Stability) ················································································20
3.2.P.8.1 안정성요약 및 결론 (Stability Summary and Conclusions) ···· 21
3.2.P.8.3 안정성자료 (Stability Data) ···························································21
다. 위약 ···············································································································21
라. 대조약 ···········································································································21
Ⅲ. 용어 정의 및 약자 (Definitions and Abbreviations) ·········· 22
Ⅳ. 임상 단계별로 요구되는 CMC 정보 요약표(Summaries) ···· 23
Ⅴ.참고자료(References) ··············································································27
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