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Handbook of Pharmaceutical Manufacturing Formulations, Second Edition最新文献

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Formulation Considerations of Liquid Products 液体制剂的配方考虑
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2016-04-19 DOI: 10.3109/9781420081244-10
Sarfaraz K. Niazi
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引用次数: 0
Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 规范:新原料药和新制剂的试验程序和验收标准:化学物质
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2016-04-19 DOI: 10.3109/9781420081275-15
Sarfaraz K Niazi
{"title":"Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances","authors":"Sarfaraz K Niazi","doi":"10.3109/9781420081275-15","DOIUrl":"https://doi.org/10.3109/9781420081275-15","url":null,"abstract":"ensure product quality and process / batch consistency, supplemented by current Good Manufacturing Practices (cGMP) and thorough product understanding. The guidance was developed for the approval of commercial products and was not intended for clinical development, although the concepts are still applicable. During development, knowledge of critical quality attributes (CQAs) may be limited, as significant changes in both synthesis / process (API) and formulation / process (drug product) would be anticipated. ICH M3 provides some useful insight for qualifying impurities during the development phase:","PeriodicalId":238873,"journal":{"name":"Handbook of Pharmaceutical Manufacturing Formulations, Second Edition","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114785689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 48
Current Regulatory Status of Over-the-Counter Products 非处方药的监管现状
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2016-04-19 DOI: 10.3109/9781420081299-11
Sarfaraz K Niazi
{"title":"Current Regulatory Status of Over-the-Counter Products","authors":"Sarfaraz K Niazi","doi":"10.3109/9781420081299-11","DOIUrl":"https://doi.org/10.3109/9781420081299-11","url":null,"abstract":"","PeriodicalId":238873,"journal":{"name":"Handbook of Pharmaceutical Manufacturing Formulations, Second Edition","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127083418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The FDA Drug Product Surveillance Program FDA药品监督项目
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2016-04-19 DOI: 10.3109/9781420081244-8
Sarfaraz K. Niazi
{"title":"The FDA Drug Product Surveillance Program","authors":"Sarfaraz K. Niazi","doi":"10.3109/9781420081244-8","DOIUrl":"https://doi.org/10.3109/9781420081244-8","url":null,"abstract":"The invention relates to a container closure system containing an overpouch with an intransparent first foil (10) and a transparent second foil (20), a transparent primary container (2) for holding a transparent pharmaceutical solution (3), wherein the transparent primary container (2) is packed within the overpouch (1) and labeled with at least one label (4) and wherein the at least one label (4) acts as a light absorbing segment having a reflection RL for light in the range of 350 nm to 800 nm and an inner surface (18) of the intransparent first foil (10) of the overpouch (1) acts as a light reflecting background having a reflection RF for light in the direction of the primary container (2) in the range of 350 nm to 800 nm with RF >RL. By the transparent second foil (20) and the inventive reflection properties it is achieved that the at least one label (4) on the primary container (2) is visible and readable. Additionally, visual inspection of the content of the transparent primary container (2) is possible. A good contrast is achieved to enhance machine and human readability.","PeriodicalId":238873,"journal":{"name":"Handbook of Pharmaceutical Manufacturing Formulations, Second Edition","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115582385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 新原料药和制剂稳定性试验的括号法和矩阵法设计
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2016-04-19 DOI: 10.3109/9781420081244-13
Sarfaraz K. Niazi
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引用次数: 132
Impurities in New Drug Substances 新原料药中的杂质
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2016-04-19 DOI: 10.3109/9781420081275-20
Sarfaraz K. Niazi
{"title":"Impurities in New Drug Substances","authors":"Sarfaraz K. Niazi","doi":"10.3109/9781420081275-20","DOIUrl":"https://doi.org/10.3109/9781420081275-20","url":null,"abstract":"","PeriodicalId":238873,"journal":{"name":"Handbook of Pharmaceutical Manufacturing Formulations, Second Edition","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116465734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 54
Composition of Proprietary Products Approved in the US 在美国批准的专利产品的组成
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2009-09-21 DOI: 10.1201/B14043-13
Sarfaraz K. Niazi
{"title":"Composition of Proprietary Products Approved in the US","authors":"Sarfaraz K. Niazi","doi":"10.1201/B14043-13","DOIUrl":"https://doi.org/10.1201/B14043-13","url":null,"abstract":"","PeriodicalId":238873,"journal":{"name":"Handbook of Pharmaceutical Manufacturing Formulations, Second Edition","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123043263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmaceutical Coating Manufacturing Formulations 制药涂料制造配方
Handbook of Pharmaceutical Manufacturing Formulations, Second Edition Pub Date : 2009-09-21 DOI: 10.3109/9781420081299-12
Sarfaraz K. Niazi
{"title":"Pharmaceutical Coating Manufacturing Formulations","authors":"Sarfaraz K. Niazi","doi":"10.3109/9781420081299-12","DOIUrl":"https://doi.org/10.3109/9781420081299-12","url":null,"abstract":"","PeriodicalId":238873,"journal":{"name":"Handbook of Pharmaceutical Manufacturing Formulations, Second Edition","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129317292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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