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標題: Titlebook: Development and Manufacture of Protein Pharmaceuticals; Steve L. Nail,Michael J. Akers Book 2002 Springer Science+Business Media New York [打印本頁]

作者: 緩和緊張狀況    時間: 2025-3-21 18:01
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作者: 外星人    時間: 2025-3-21 20:47
1078-0467 aging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength,978-1-4613-5127-6978-1-4615-0549-5Series ISSN 1078-0467
作者: gonioscopy    時間: 2025-3-22 02:35
Development and Manufacture of Protein Pharmaceuticals
作者: Fsh238    時間: 2025-3-22 08:09
https://doi.org/10.1007/978-3-642-61275-6ture does not yet permit the more straightforward type of analysis utilized for small molecules to be simply applied. Nevertheless, it is still possible to treat proteins primarily as chemical (rather than biological) entities through an understanding of their structure and stability and use of a mo
作者: collateral    時間: 2025-3-22 11:49

作者: 向外    時間: 2025-3-22 13:04
Preformulation Studies as an Essential Guide to Formulation Development and Manufacture of Protein aceutically acceptable drug substance. In the case of conventional, small-molecule (nonmacromolecular) pharmaceuticals, this procedure can usually be accomplished to a high degree of scientific rigor. For example, the atomic level structures of these compounds are usually known from a combination of
作者: 向外    時間: 2025-3-22 19:21

作者: Aesthete    時間: 2025-3-22 21:16
Aseptic Processing of Protein Pharmaceuticals,h clinical supplies and the commercial market, from the perspective of the unique characteristics of protein-containing drug products. The discussion will be restricted to solution, suspension, and lyophilized dosage forms in final containers made of glass or plastic. It will present a conceptual fr
作者: entreat    時間: 2025-3-23 04:45

作者: maudtin    時間: 2025-3-23 08:43

作者: 角斗士    時間: 2025-3-23 13:29

作者: 遷移    時間: 2025-3-23 14:39
Quality Assurance and Quality Control for Biopharmaceutical Products,suring the consistency, quality, and safety of the manufactured drug product. Fortunately, many QA and QC systems are common to different manufacturing processes, such as chemical synthesis, isolation of biologies from natural sources, and production of biopharmaceuticals through recombinant DNA tec
作者: 除草劑    時間: 2025-3-23 20:00
Regulatory Considerations in the Development of Protein Pharmaceuticals,and Drug Administration (FDA). It could be argued that biotechnology, as a discipline, was not new. Depending on the definition one selected, biotechnology could be considered as old as traditional beer- or bread-making, as indicated by one of the early definitions: “Biotechnology involves the appli
作者: 協(xié)定    時間: 2025-3-24 00:58
Aseptic Processing of Protein Pharmaceuticals,amework for the development of aseptic processes at the lab bench, subsequent scale-up to clinical batches, and, finally, validation of the fully scaled-up and well-defined processes for commercial manufacturing of the drug product.
作者: 蘆筍    時間: 2025-3-24 04:47

作者: 明確    時間: 2025-3-24 09:37

作者: 抗生素    時間: 2025-3-24 12:39

作者: AGGER    時間: 2025-3-24 15:16

作者: Synovial-Fluid    時間: 2025-3-24 20:01

作者: Ledger    時間: 2025-3-25 03:14
Exploring Grouping Problems in Industryntrol, product testing, and auditing (see Table I). Application of these quality systems throughout the pharmaceutical industry is described in numerous reference books (Bryant, 1984; Peine, 1994; Sharp, 1991; Willig and Stoker, 1992).
作者: 大吃大喝    時間: 2025-3-25 04:35

作者: 虛度    時間: 2025-3-25 10:50

作者: Density    時間: 2025-3-25 12:06
Formulation Development of Protein Dosage Forms,enges in protein formulation development are typically enormous. The instability of these reactive and complex molecules must be considered not only in the . process, but also in development of the . and the . process. These three areas are intimately and inseparably connected.
作者: Cerumen    時間: 2025-3-25 18:33
Fundamentals of Thermal Sterilization Processes,versible. However, as currently defined in the pharmaceutical industry, the effectiveness of a sterilization process is determined by the statistical probability of a non-sterile unit (PNSU) in a lot or batch of product.
作者: 臆斷    時間: 2025-3-25 23:38

作者: PRE    時間: 2025-3-26 01:12
https://doi.org/10.1007/978-3-319-44394-2cation of biological systems to technical and industrial processes” (Bonk, 1987). However, as applied to production of pharmaceutical products, it was a new technology for products intended to diagnose and treat diseases or conditions in humans.
作者: tattle    時間: 2025-3-26 08:16
Book 2002ny sources are available for the pharmaceutical develop- ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical mo
作者: DUCE    時間: 2025-3-26 09:05
Fundamentals of Freeze-Drying,sition of the formulation and the process conditions used during freeze-drying. Although this approach ultimately may result in an acceptable product, it is a time-consuming and labor-intensive process, and is unlikely to result in the highest quality product attainable or in a freeze-dry process which is optimized.
作者: 轉(zhuǎn)向    時間: 2025-3-26 16:06

作者: cinder    時間: 2025-3-26 19:00

作者: Integrate    時間: 2025-3-26 22:14
Asymptotically Dominant Properties a significant challenge. Most proteins, as natural physiological molecules, are inherently unstable outside the human or animal body. Stability challenges in protein formulation development are typically enormous. The instability of these reactive and complex molecules must be considered not only i
作者: 凝乳    時間: 2025-3-27 04:58
https://doi.org/10.1007/978-3-7643-8827-0h clinical supplies and the commercial market, from the perspective of the unique characteristics of protein-containing drug products. The discussion will be restricted to solution, suspension, and lyophilized dosage forms in final containers made of glass or plastic. It will present a conceptual fr
作者: 百靈鳥    時間: 2025-3-27 06:32

作者: ANTI    時間: 2025-3-27 09:40
Length-Based and Quotient Attacks production of protein pharmaceuticals. The focus of this chapter is on the use of membrane filters for purification and sterilization of protein pharmaceuticals. However, we also review other important uses of membranes and nonmembrane filters in the production of protein pharmaceuticals. The reade
作者: Metamorphosis    時間: 2025-3-27 16:35
Orthomorphismes Et f-Anneaux Archimediens,sition of the formulation and the process conditions used during freeze-drying. Although this approach ultimately may result in an acceptable product, it is a time-consuming and labor-intensive process, and is unlikely to result in the highest quality product attainable or in a freeze-dry process wh
作者: 愛了嗎    時間: 2025-3-27 20:10
Exploring Grouping Problems in Industrysuring the consistency, quality, and safety of the manufactured drug product. Fortunately, many QA and QC systems are common to different manufacturing processes, such as chemical synthesis, isolation of biologies from natural sources, and production of biopharmaceuticals through recombinant DNA tec
作者: 書法    時間: 2025-3-28 00:44

作者: Adjourn    時間: 2025-3-28 05:01
Development and Manufacture of Protein Pharmaceuticals978-1-4615-0549-5Series ISSN 1078-0467
作者: Dignant    時間: 2025-3-28 07:29

作者: Obliterate    時間: 2025-3-28 11:45
https://doi.org/10.1007/978-1-4615-0549-5Filtration; development; manufacturing; pharmaceutical; protein; research
作者: Malcontent    時間: 2025-3-28 17:24





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