標(biāo)題: Titlebook: Biosimilars; Regulatory, Clinical Hiten J. Gutka,Harry Yang,Shefali Kakar Book 2018 American Association of Pharmaceutical Scientists 2018 [打印本頁] 作者: 日月等 時(shí)間: 2025-3-21 17:34
書目名稱Biosimilars影響因子(影響力)
書目名稱Biosimilars影響因子(影響力)學(xué)科排名
書目名稱Biosimilars網(wǎng)絡(luò)公開度
書目名稱Biosimilars網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Biosimilars被引頻次
書目名稱Biosimilars被引頻次學(xué)科排名
書目名稱Biosimilars年度引用
書目名稱Biosimilars年度引用學(xué)科排名
書目名稱Biosimilars讀者反饋
書目名稱Biosimilars讀者反饋學(xué)科排名
作者: 嚴(yán)厲譴責(zé) 時(shí)間: 2025-3-21 22:18 作者: STERN 時(shí)間: 2025-3-22 02:09 作者: 描述 時(shí)間: 2025-3-22 07:38 作者: Lethargic 時(shí)間: 2025-3-22 10:41 作者: EXCEL 時(shí)間: 2025-3-22 14:18
Learning Chinese in a Multilingual Spacent. The biosimilar drug product development strategy has to take additional multiple factors into consideration including matching the reference product presentation, intellectual property and the current state of the art in science and technology. This chapter reviews these factors in detail using case-studies from currently approved biosimilars.作者: pester 時(shí)間: 2025-3-22 19:46 作者: 講個(gè)故事逗他 時(shí)間: 2025-3-22 22:37
Design and Implementation of Successful Regulatory Strategies in Biosimilar Developmental they are required to undergo head to head similarity exercises [CMC, nonclinical and clinical (as~needed)] against their reference product already marketed in the region/country of interest or countries with stringent regulatory requirements.作者: inspiration 時(shí)間: 2025-3-23 05:05
Drug Product Considerations for Biosimilarsnt. The biosimilar drug product development strategy has to take additional multiple factors into consideration including matching the reference product presentation, intellectual property and the current state of the art in science and technology. This chapter reviews these factors in detail using case-studies from currently approved biosimilars.作者: 洞察力 時(shí)間: 2025-3-23 05:46 作者: 紅腫 時(shí)間: 2025-3-23 09:51 作者: 先驅(qū) 時(shí)間: 2025-3-23 16:11 作者: 絕食 時(shí)間: 2025-3-23 19:57
The Changing US Reimbursement Landscape and Biosimilarse passage of the Affordable Care Act (ACA) created an FDA approval pathway for biosimilars, but that is the tip of the iceberg as it pertains to how a biosimilar will actually get to the patient. As a general rule, legislation contains very little detail and requires much regulatory guidance by vari作者: 新星 時(shí)間: 2025-3-23 23:55 作者: 冷峻 時(shí)間: 2025-3-24 05:07
Design and Implementation of Successful Regulatory Strategies in Biosimilar Developmenten shown to provide “dramatically reduced disability for patients with inflammatory diseases, such as rheumatoid arthritis, extended the lives of patients with many cancers and also provide lifesaving replacement proteins for patients with rare diseases” (US Food and Drug Administration, .; Krishnan作者: Adrenaline 時(shí)間: 2025-3-24 06:35 作者: 夸張 時(shí)間: 2025-3-24 13:09
EU Perspective on Biosimilarsation is granted by the Commission of the European Union (EU). Thus, each biosimilar has one regulatory assessment as well as the same product information and conditions of use in the EU. The current regulatory framework is a result of 20?years evolution of legislation and regulatory guidelines. The作者: 怒目而視 時(shí)間: 2025-3-24 18:04 作者: 協(xié)定 時(shí)間: 2025-3-24 22:45
QbD in Biopharmaceutical Manufacturing and Biosimilar Developments had been proven, clinical efficacy and safety profiles established, with large markets and sales margins, making them attractive targets for many biopharmaceutical companies, both large and small. However, inherent properties of the molecules result in higher levels of risk in the eyes of regulato作者: condemn 時(shí)間: 2025-3-24 23:59
Drug Product Considerations for Biosimilarsn of the drug product for a biosimilar is of utmost importance, as it directly relates to patient efficacy, safety and product quality, even as it defines the similarity of the product to the reference innovator product. There are various components of a drug product: the formulation, the container 作者: 付出 時(shí)間: 2025-3-25 05:01
Principles of Analytical Similarity Assessmentates a carefully designed analytical study program. Although regulatory agencies, such as EMA and US FDA, have published guidance documents outlining the requirements for analytical similarity assessment, the implications are often not fully understood by biosimilar developers. This chapter discusse作者: 粗魯?shù)娜?nbsp; 時(shí)間: 2025-3-25 10:24
Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval access to life-enhancing therapies. To ensure safety, efficacy, and bioequivalence of these biologically-derived products, their commercialization pathway is governed by stringent, and sometimes region-specific, clinical and quality requirements. Biosimilars represent a unique class of biopharmaceut作者: aplomb 時(shí)間: 2025-3-25 13:03 作者: Blemish 時(shí)間: 2025-3-25 16:16 作者: 蓋他為秘密 時(shí)間: 2025-3-25 21:32
Protein Particulates and Biosimilar Development: Analytical Tools and Therapeutic Implications. Indeed, the presence of particles is one the top 10 reasons for product recalls. The risk of immunogenicity and adverse clinical reactions in patients has resulted in subvisible particles becoming one of the major focus topics for regulatory agencies. The US FDA has issued several guidance documen作者: 性行為放縱者 時(shí)間: 2025-3-26 00:34
Book 2018arity Considerations for Biosimilars..Section V: Clinical aspects of Biosimilar Development..Section VI: Biosimilars- Global Development and Clinical Experience..Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more a作者: ablate 時(shí)間: 2025-3-26 07:11 作者: 出血 時(shí)間: 2025-3-26 12:24
Learning C# by Programming Gamesic profiles, and comparative clinical trial data to eliminate any residual uncertainty. Beyond development and regulatory complexities, much of the fascination with biosimilars stems from ongoing efforts to establish unique commercialization blueprints, educate stakeholders, and collect and present 作者: INCH 時(shí)間: 2025-3-26 16:06 作者: CODE 時(shí)間: 2025-3-26 19:34 作者: strain 時(shí)間: 2025-3-26 23:58
https://doi.org/10.1007/978-3-540-79084-6milar is expected to produce clinical outcomes that are not meaningfully different from those expected with the reference biologic drug. This chapter is intended to present the Canadian clinical information requirements for biosimilars, and how they relate to the Canadian regulatory framework, while作者: Palliation 時(shí)間: 2025-3-27 02:14 作者: 縫紉 時(shí)間: 2025-3-27 05:29
https://doi.org/10.1007/978-3-031-00307-3biologic. The concepts become even more critical with the development of biosimilar molecules, where decisions that are made at very early stages with respect to cell lines, fermentation parameters, and purification strategy will impact the chemical and physical properties of the product. A thorough作者: 取回 時(shí)間: 2025-3-27 12:54 作者: 殘廢的火焰 時(shí)間: 2025-3-27 15:36
https://doi.org/10.1007/978-981-10-8100-2xpectations for approval of protein-based biosimilars in key regions of the world with known requirements for marketing authorization. The authors then demonstrate how analytical characterization methods may be managed within a broad and general lifecycle characterization framework. It is the author作者: 敲竹杠 時(shí)間: 2025-3-27 20:08 作者: 共同給與 時(shí)間: 2025-3-27 22:59
Lecture Notes in Computer Scienceormat and magnetic beads-based Luminex format. The first few sections of this chapter will focus on the applications and findings from the ELISA-based PCA and the last two sections will discuss the Luminex system in elucidating detains of mAbs HOS under different stress conditions. Results will be d作者: 仔細(xì)閱讀 時(shí)間: 2025-3-28 03:20 作者: lactic 時(shí)間: 2025-3-28 09:59
Biosimilars 101: An Introduction to Biosimilarsic profiles, and comparative clinical trial data to eliminate any residual uncertainty. Beyond development and regulatory complexities, much of the fascination with biosimilars stems from ongoing efforts to establish unique commercialization blueprints, educate stakeholders, and collect and present 作者: 繁重 時(shí)間: 2025-3-28 12:57
The Changing US Reimbursement Landscape and Biosimilars weigh in with their own coverage decisions, but typically follow the coding of biosimilars as set forth by CMS. This chapter will assess the existing reimbursement landscape for biosimilars and will address key considerations and implications around current decisions that will impact biosimilars’ m作者: confederacy 時(shí)間: 2025-3-28 15:16 作者: Ornithologist 時(shí)間: 2025-3-28 21:04 作者: anaerobic 時(shí)間: 2025-3-28 23:42
EU Perspective on Biosimilarsn-EU country in certain non-clinical and clinical studies provided that it can be shown to be a relevant as a comparator. The high similarity of a biosimilar and its reference is demonstrated by physico-chemical and structural as well as in vitro functional comparability studies. Non-clinical in viv作者: bypass 時(shí)間: 2025-3-29 04:02 作者: 權(quán)宜之計(jì) 時(shí)間: 2025-3-29 08:31 作者: 使人煩燥 時(shí)間: 2025-3-29 15:07
Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval xpectations for approval of protein-based biosimilars in key regions of the world with known requirements for marketing authorization. The authors then demonstrate how analytical characterization methods may be managed within a broad and general lifecycle characterization framework. It is the author作者: 長矛 時(shí)間: 2025-3-29 19:20
Higher Order Structure Methods for Similarity Assessmentcterized, or the subsequent non-clinical or clinical study designs. The diversity in method selection appears to arise from two factors: the range of opinions across the industry on the ability of HOS methods to inform technical decisions, and the regulatory risk tolerance of different organizations作者: JUST 時(shí)間: 2025-3-29 22:26
Protein Conformational Array Technology for Biosimilar Higher Order Structure Analysisormat and magnetic beads-based Luminex format. The first few sections of this chapter will focus on the applications and findings from the ELISA-based PCA and the last two sections will discuss the Luminex system in elucidating detains of mAbs HOS under different stress conditions. Results will be d作者: 險(xiǎn)代理人 時(shí)間: 2025-3-30 02:09 作者: 木訥 時(shí)間: 2025-3-30 05:03 作者: 莎草 時(shí)間: 2025-3-30 09:03 作者: 小卒 時(shí)間: 2025-3-30 14:45 作者: grotto 時(shí)間: 2025-3-30 17:53
Learning C# by Programming Gamesing the so-called patent dance, the two waves of litigation, and due to its significance to biosimilar practice, . review..The chapter first examines the statutory framework of the Act that governs the contemplated exchange of confidential-information between the sponsor and biosimilar applicant res作者: 疏遠(yuǎn)天際 時(shí)間: 2025-3-30 21:34 作者: 鎮(zhèn)痛劑 時(shí)間: 2025-3-31 04:54 作者: Ptosis 時(shí)間: 2025-3-31 06:19
R. Ribes,P. Kuschnir,J. M. Jimenez-Hoyuelaation is granted by the Commission of the European Union (EU). Thus, each biosimilar has one regulatory assessment as well as the same product information and conditions of use in the EU. The current regulatory framework is a result of 20?years evolution of legislation and regulatory guidelines. The作者: Seminar 時(shí)間: 2025-3-31 10:24
Mediastinum and Pulmonary Circulation,g process development and production, and control mechanisms, including analytical testing both in-process and of the finished drug, to show the process is controlled and reproducible. For a candidate biosimilar much is already understood about the chemistry and properties of the drug by thorough ch作者: 線 時(shí)間: 2025-3-31 15:05
https://doi.org/10.1007/978-3-031-00307-3s had been proven, clinical efficacy and safety profiles established, with large markets and sales margins, making them attractive targets for many biopharmaceutical companies, both large and small. However, inherent properties of the molecules result in higher levels of risk in the eyes of regulato作者: CORD 時(shí)間: 2025-3-31 19:39
Learning Chinese in a Multilingual Spacen of the drug product for a biosimilar is of utmost importance, as it directly relates to patient efficacy, safety and product quality, even as it defines the similarity of the product to the reference innovator product. There are various components of a drug product: the formulation, the container 作者: 向外 時(shí)間: 2025-3-31 22:39 作者: Sarcoma 時(shí)間: 2025-4-1 04:01
