標(biāo)題: Titlebook: Quality by Design for Biopharmaceutical Drug Product Development; Feroz Jameel,Susan Hershenson,Sheryl Martin-Moe Book 2015 Springer Scien [打印本頁(yè)] 作者: abandon 時(shí)間: 2025-3-21 17:39
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development影響因子(影響力)
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development影響因子(影響力)學(xué)科排名
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development網(wǎng)絡(luò)公開(kāi)度
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development網(wǎng)絡(luò)公開(kāi)度學(xué)科排名
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development被引頻次
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development被引頻次學(xué)科排名
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development年度引用
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development年度引用學(xué)科排名
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development讀者反饋
書(shū)目名稱(chēng)Quality by Design for Biopharmaceutical Drug Product Development讀者反饋學(xué)科排名
作者: PRE 時(shí)間: 2025-3-21 21:16 作者: Reclaim 時(shí)間: 2025-3-22 03:53 作者: Cursory 時(shí)間: 2025-3-22 05:41 作者: 補(bǔ)角 時(shí)間: 2025-3-22 09:29 作者: grieve 時(shí)間: 2025-3-22 12:56 作者: 格言 時(shí)間: 2025-3-22 20:09 作者: enterprise 時(shí)間: 2025-3-22 21:30
Ron Taticek,Jun Liuchine vision and control aspects detailed, along with reports on the mission performance the first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc作者: ingestion 時(shí)間: 2025-3-23 02:47
Sheryl Martin-Moe,Carol Nastchine vision and control aspects detailed, along with reports on the mission performance the first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc作者: Mediocre 時(shí)間: 2025-3-23 06:27 作者: ADORE 時(shí)間: 2025-3-23 10:49
Bernardo Perez-Ramírez PhD,Nicholas Guziewicz,Robert Simler,Alavattam Sreedharachine vision and control aspects detailed, along with reports on the mission performance the first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc作者: Commonwealth 時(shí)間: 2025-3-23 17:55
Alavattam Sreedhara,Rita L. Wong,Yvonne Lentz,Karin Schoenhammer,Christoph Starkchine vision and control aspects detailed, along with reports on the mission performance the first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc作者: meditation 時(shí)間: 2025-3-23 20:16
Joseph Edward Shultz,Herb Lutz,Suma Raochine vision and control aspects detailed, along with reports on the mission performance the first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc作者: 異端 時(shí)間: 2025-3-24 00:40 作者: Bother 時(shí)間: 2025-3-24 03:23 作者: mendacity 時(shí)間: 2025-3-24 07:19
Paul Harber aspects in routing protocols have not been given enough attention, since most of the routing protocols in WSNs have not been designed with security requirements in mind?[.,.,.,.,.]. In this chapter, the main models of WSN with their advantages and limitations are discussed, specially the clustering作者: 會(huì)議 時(shí)間: 2025-3-24 12:07 作者: 獨(dú)白 時(shí)間: 2025-3-24 18:30
Rey T. Chern,Jeffrey C. Givand,Robin Hwang,Thomas J. Nikolaidentity, complex objects and user-defined operations, classes, inheritance; it provides capabilities for defining deductive rules, that can be used to define views and integrity constraints, to formulate queries, to specify methods to compute derived information; it supports a powerful language for 作者: armistice 時(shí)間: 2025-3-24 21:39
Feroz Jameel,Cenk Undey,Paul M. Kovach,Jart Tanglertpaibul作者: 繁殖 時(shí)間: 2025-3-25 02:58 作者: 酷熱 時(shí)間: 2025-3-25 05:18
Barbara L. Rellahan,Steven Kozlowski,Patrick Swannhe first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc978-1-84996-633-7978-1-84628-638-4作者: parallelism 時(shí)間: 2025-3-25 07:33
Ambarish Shah,Feroz Jameel,Sajal M. Patelhe first vehicles using these innovative techniques built at Munich. Pointers to the future development and likely applications of this hugely important field of research are presented...Dynamic Vision for Perc978-1-84996-633-7978-1-84628-638-4作者: 激勵(lì) 時(shí)間: 2025-3-25 14:15 作者: giggle 時(shí)間: 2025-3-25 18:55 作者: 模范 時(shí)間: 2025-3-25 21:49
Sajal M. Patel,Feroz Jameel,Samir U. Sane,Madhav Kamatk presents original research on the application of a dynamic WSN to solve the problem of energy consumption in a secure WSN during the process of data aggregation and transmission. Written by respected experts 978-3-030-06521-8978-3-319-92807-4Series ISSN 2198-4182 Series E-ISSN 2198-4190 作者: 致敬 時(shí)間: 2025-3-26 03:46 作者: Ascendancy 時(shí)間: 2025-3-26 05:22
2210-7371 ealm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitori978-1-4939-5152-9978-1-4939-2316-8Series ISSN 2210-7371 Series E-ISSN 2210-738X 作者: ANNUL 時(shí)間: 2025-3-26 12:23
2210-7371 cialization of biopharmaceutical drug product for the biotec.This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this 作者: 構(gòu)想 時(shí)間: 2025-3-26 12:39
Definitions and Scope of Key Elements of QbD,ical process parameters (CPPs), a comprehensive control strategy, and lifecycle management. In this chapter, we have provided the basic definitions and considerations necessary to deliver these key elements for biopharmaceutical development.作者: 返老還童 時(shí)間: 2025-3-26 20:24 作者: 能得到 時(shí)間: 2025-3-26 22:53
Application of QbD Principles for Lyophilized Formulation Development,lopment. Lyophilization process design and development is discussed in the subsequent chapter; however, formulation development takes into consideration the impact of process parameters on product quality attributes.作者: 甜食 時(shí)間: 2025-3-27 05:08
Application of QbD Elements in the Development and Scale-Up of a Commercial Filtration Process,sed on sound science and quality risk management. This chapter describes a mock case study with illustration of how QbD elements could be applied in the selection of optimal filter(s) and the development of filtration process that is well understood, well controlled, safe, and robust.作者: 大方一點(diǎn) 時(shí)間: 2025-3-27 06:52
Lyophilization Process Design and Development Using QbD Principles,he process rather than monitoring offline at the end of the process. This chapter describes how QbD elements—risk assessment, process characterization, PAT (Process Analytical Tool), and Design Space—can be applied to design, develop, and scale-up of the lyophilization process.作者: dialect 時(shí)間: 2025-3-27 11:32
Challenges and Opportunities for Biotech Quality by Design,tream and downstream process could serve to support the overall development and manufacture of a quality product. The ultimate goal of QbD is a well-understood process and high-quality product with a commitment to continuous improvement.作者: Benzodiazepines 時(shí)間: 2025-3-27 15:26
Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Qualir summarizes key observations from the pilot program submissions and meetings for monoclonal antibody products related to the application of QbD concepts to biotechnology product development and manufacture.作者: 熒光 時(shí)間: 2025-3-27 21:15
Drug Substance Frozen Storage and Thawing,lowed by a description of the commercial freeze-thaw unit operation and associated equipment. The QbD risk-based strategy is then discussed in detail. The overall approach is illustrated through a case study that shows how small-scale models are leveraged for characterization of freeze-thaw production process.作者: 共同時(shí)代 時(shí)間: 2025-3-28 02:01 作者: libertine 時(shí)間: 2025-3-28 06:08
Challenges and Opportunities for Biotech Quality by Design,he biotechnology-derived products. This chapter describes bioprocessing schemes for both liquid and lyophilized drug products. The International Conference on Harmonization (ICH) guidance documents are discussed in the context of bioprocessing to provide examples of the systematic QbD approach. Addi作者: Narcissist 時(shí)間: 2025-3-28 06:35 作者: Aesthete 時(shí)間: 2025-3-28 14:01
Definitions and Scope of Key Elements of QbD,development of biopharmaceuticals. The successful implementation of a QbD approach requires a good understanding of its key elements. These include the quality target product profile (QTPP), critical quality attributes (CQAs), critical material attributes (CMAs), risk assessments, design space, crit作者: COUCH 時(shí)間: 2025-3-28 15:18 作者: 沙漠 時(shí)間: 2025-3-28 21:18 作者: 發(fā)展 時(shí)間: 2025-3-29 01:40
Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Fory identification of suitable protein candidates to be moved into formulation development and assess their developmentability/manufacturability potential. This predevelopment risk-based approach is essential for (i) understanding the solution behavior of therapeutic proteins, (ii) identifying prelimi作者: conformity 時(shí)間: 2025-3-29 06:50
Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products,ed during development, this knowledge was not always formally documented or proactively submitted to regulators. In recent years, the US Food and Drug Administration has launched an initiative for pharmaceutical quality for the twenty-first century to modernize pharmaceutical manufacturing and impro作者: 半身雕像 時(shí)間: 2025-3-29 09:42
Application of QbD Principles for Lyophilized Formulation Development, (generally water) does not assure stability. The formulation composition as well as the lyophilization process parameters is critical to achieve desired drug product quality attributes. This chapter describes how the elements of Quality by Design (QbD) can be applied to lyophilized formulation deve作者: 使顯得不重要 時(shí)間: 2025-3-29 12:11 作者: averse 時(shí)間: 2025-3-29 18:23 作者: probate 時(shí)間: 2025-3-29 23:36 作者: nocturia 時(shí)間: 2025-3-30 02:23
Application of QbD Elements in the Development and Scale-Up of a Commercial Filtration Process,uring. Understanding filter characteristics and factors that contribute to their performance is central to the selection of the filter and the design of the process. Quality by Design (QbD) is a systematic approach to development that enables product and process understanding and process control, ba作者: 勉強(qiáng) 時(shí)間: 2025-3-30 05:46 作者: 蒙太奇 時(shí)間: 2025-3-30 09:15
Lyophilization Process Design and Development Using QbD Principles,e. The lyophilization process is based on fundamental principles of heat and mass transfer, and the overall understanding of the impact of process parameters on product quality attributes has increased significantly over the past few decades. Quality by design (QbD) aims at building quality within t作者: 聰明 時(shí)間: 2025-3-30 13:44 作者: 低三下四之人 時(shí)間: 2025-3-30 20:11
Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products, the company. Currently, few companies have this process in mind during the development of the product. The adoption of a risk-based approach compares and contrasts the capability of the distribution process with the demonstrated requirements of the product. Regulators and industry-leading companies作者: 群島 時(shí)間: 2025-3-31 00:14 作者: 粗鄙的人 時(shí)間: 2025-3-31 04:48 作者: 放逐 時(shí)間: 2025-3-31 07:44 作者: 勤勞 時(shí)間: 2025-3-31 10:57 作者: 復(fù)習(xí) 時(shí)間: 2025-3-31 16:22
A QbD Approach in the Development and Scale-Up of Mixing Processes, bulk drug product has been chosen to illustrate the mixing characterization study design to identify operating conditions at pilot scale (50?L). The use of models for scale-up coupled with the data obtained at 50?L scale is used to predict operating conditions at the 300?L scale.作者: Default 時(shí)間: 2025-3-31 18:00
Application of QbD Elements in the Development and Scale-up of Commercial Filling Process,ally better understand the product and process and helps in quality risk management. In this chapter, the application of various elements of QbD in the development and transfer of a commercial filling process of an X-mAb for prefilled syringe (PFS) presentation is demonstrated through a mock case study.作者: 摘要記錄 時(shí)間: 2025-3-31 22:17 作者: 啟發(fā) 時(shí)間: 2025-4-1 03:09
Applicability of QbD for Vaccine Drug Product Development,may not lead to regulatory relief during licensure, QbD can be very helpful in understanding vaccine processes and can potentially improve vaccine production by making the process less empirical and more consistent in terms of quality.
