標(biāo)題: Titlebook: Dose Finding and Beyond in Biopharmaceutical Development; Jingjing Ye,Ding-Geng Chen,Joseph C. Cappelleri Book 2025 The Editor(s) (if appl [打印本頁(yè)] 作者: EVOKE 時(shí)間: 2025-3-21 18:44
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書目名稱Dose Finding and Beyond in Biopharmaceutical Development被引頻次
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書目名稱Dose Finding and Beyond in Biopharmaceutical Development讀者反饋
書目名稱Dose Finding and Beyond in Biopharmaceutical Development讀者反饋學(xué)科排名
作者: 沒(méi)有貧窮 時(shí)間: 2025-3-21 23:38 作者: Demulcent 時(shí)間: 2025-3-22 04:20 作者: 手銬 時(shí)間: 2025-3-22 07:35 作者: nominal 時(shí)間: 2025-3-22 08:54 作者: Adrenaline 時(shí)間: 2025-3-22 16:27
https://doi.org/10.1007/978-3-642-92507-8luding leukemia 2023, kidney cancer, and melanoma (Siegel, CA Cancer J Clin 73(1):17–48, 2023). The development of targeted therapies, in particular, has dramatically altered the therapeutic landscape and improved outcomes for patients. Despite the seismic changes that have occurred in the field, so作者: Adrenaline 時(shí)間: 2025-3-22 18:05
dbreaking initiative had fundamentally changed the oncology dose-finding paradigm: discouraging outdated conventions since the era of cytotoxic agents (identifying the maximum tolerated dose, MTD), and embracing new practices of identifying the optimal dosage among multiple doses based on totality o作者: Fantasy 時(shí)間: 2025-3-22 22:08
Bits, Bytes, Words and Numbers,e treatments, oncology trials need to start human research at a lower dose level and then move up and down through some dose levels in a process called dose finding that helps determine a safe dose level. The toxicity of these oncology drugs is always assumed to increase with dose. However, unlike i作者: IOTA 時(shí)間: 2025-3-23 03:41 作者: glucagon 時(shí)間: 2025-3-23 06:27 作者: flutter 時(shí)間: 2025-3-23 13:19 作者: 爭(zhēng)議的蘋果 時(shí)間: 2025-3-23 17:56 作者: conquer 時(shí)間: 2025-3-23 18:00
,Wie demokratisch ist die Türkei?,(ed) Dose finding in drug development. Springer, New York, p 146–171, 2006) to confirm the proof of concept and identify the minimum effective dose (MED) in Phase II clinical trials was first introduced in the early 2000s. The MCP-Mod method has significantly transformed the way dose-finding studies作者: Fecundity 時(shí)間: 2025-3-23 23:12 作者: 審問(wèn),審訊 時(shí)間: 2025-3-24 05:11 作者: 功多汁水 時(shí)間: 2025-3-24 08:19 作者: 調(diào)色板 時(shí)間: 2025-3-24 12:20
Book 2025ook details advancements made in drug development...Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maxi作者: 落葉劑 時(shí)間: 2025-3-24 17:20
Adam Smith. New Intuitions For A New Age,sents a curve-free design and a hybrid design for BED-finding trials involving one agent, assuming a monotonic dose–toxicity curve and a unimodal dose–efficacy curve. The last section of the chapter provides examples and demonstrations of our Web-based R packages.作者: 闡釋 時(shí)間: 2025-3-24 19:30
Monotonic Dose–Response and Curve-Free Designs for Phase I Dose-Finding Trialssents a curve-free design and a hybrid design for BED-finding trials involving one agent, assuming a monotonic dose–toxicity curve and a unimodal dose–efficacy curve. The last section of the chapter provides examples and demonstrations of our Web-based R packages.作者: 6Applepolish 時(shí)間: 2025-3-25 02:07 作者: syring 時(shí)間: 2025-3-25 05:42
Dose Optimization of Oncology Drugs: A Clinical and Regulatory Perspectiveluding leukemia 2023, kidney cancer, and melanoma (Siegel, CA Cancer J Clin 73(1):17–48, 2023). The development of targeted therapies, in particular, has dramatically altered the therapeutic landscape and improved outcomes for patients. Despite the seismic changes that have occurred in the field, so作者: 包租車船 時(shí)間: 2025-3-25 10:15 作者: 泛濫 時(shí)間: 2025-3-25 14:22
Novel Oncology Dose-Finding Designs for the New Millenniume treatments, oncology trials need to start human research at a lower dose level and then move up and down through some dose levels in a process called dose finding that helps determine a safe dose level. The toxicity of these oncology drugs is always assumed to increase with dose. However, unlike i作者: dictator 時(shí)間: 2025-3-25 16:56
Practical Guidance on Oncology Dose Escalation Designshe dose limiting toxicity (DLT) data have been widely implemented in real clinical trials, including rule-based designs (e.g., i3+3), model-based designs (e.g., CRM and BLRM) and model-assisted designs (e.g., mTPI, mTPI-2, and BOIN). In this chapter, we have a brief review of popular novel designs, 作者: COKE 時(shí)間: 2025-3-25 21:20
Monotonic Dose–Response and Curve-Free Designs for Phase I Dose-Finding Trialsed designs typically use parametric models to facilitate the exchange of information across dose levels, curve-free designs rely solely on the monotonic assumption to extrapolate data between doses. In the first part of this chapter, we present several curve-free designs for phase I trials that were作者: 興奮過(guò)度 時(shí)間: 2025-3-26 02:36 作者: 社團(tuán) 時(shí)間: 2025-3-26 06:04 作者: 尖牙 時(shí)間: 2025-3-26 12:25 作者: 公共汽車 時(shí)間: 2025-3-26 16:03
Patient-Reported Tolerability in Oncology Drug DevelopmentThere is a growing understanding of and encouragement for the use of PROs to capture tolerability. Traditionally, tolerability has been defined as the absence of serious adverse events. More recent and patient-centric definitions of tolerability have been put forward, focusing on how patients feel a作者: Commission 時(shí)間: 2025-3-26 17:21 作者: 老巫婆 時(shí)間: 2025-3-26 23:12
Emerging Topics in Dose-Finding and Beyond . revisits the basic principles of dose-finding from the 2006 book. Section . discusses and compares the topic of dose-finding in oncology versus non-oncologic diseases in drug development; as a result, this section also introduces a paradigm shift in oncology drug development. Section . discusses 作者: Preserve 時(shí)間: 2025-3-27 04:23
Dose Optimization of Oncology Drugs: A Clinical and Regulatory Perspectivention to prioritize optimizing the dosage of oncology drugs in the pre-approval setting, marking a shift away from the standard practice (FDA, Project Optimus. Available via .. Cited 18 Nov 2023, 2023a; Optimizing the dosage of human prescription drugs and biological products for the treatment of on作者: 偽造 時(shí)間: 2025-3-27 05:49
FDA’s Project Optimus: The “Paradigm-Shifting” Initiative for Oncology Drug Development of novel approaches recently developed that follow the guiding principles of the initiative, some of which had been accepted by the Agency for implementation in real trials. Some regulatory perspectives with suggested analyses in the optimization data package and practical considerations related to作者: 凹槽 時(shí)間: 2025-3-27 11:38
Novel Oncology Dose-Finding Designs for the New Millenniume dose of the study drug that can be used in later-phase trials. The traditional 3+3 design in oncology was used for many years to find the maximum tolerated dose (MTD) for chemotherapies. In recent years, several different model-based, model-assisted, and algorithm-based designs for dose finding ha作者: arrhythmic 時(shí)間: 2025-3-27 15:08
Practical Guidance on Oncology Dose Escalation Designsative analysis in terms of operating characteristics in simulation studies, and provide some recommendations to improve the practice. A new approach to improve the MTD determination by DLT weighting is also presented. Finally, some methods beyond DLT-based dose escalation designs are introduced to h作者: FIR 時(shí)間: 2025-3-27 18:15 作者: 消毒 時(shí)間: 2025-3-27 23:43
A Generalized Rank-Based Inferential Seamless Phase 2/3 Design with Dose Selectioncussed in Li et al. (.. In .. ICSA Book Series in Statistics, pp. 285–299. Springer International Publishing Switzerland (2015)), the combined analysis may cause type I error inflation due to the correlation and dose selection. Sidák adjustment has been proposed to control the overall type I error b作者: 入會(huì) 時(shí)間: 2025-3-28 03:39
Comparing MCP-Mod and Ordinal Linear Contrast Test in Dose-Finding Clinical Trials: A Thorough Exami convergence issues. Finally, the performance of MCP-Mod is subject to whether the true dose-response relationship is close to one of the selected candidate models. In contrast, the ordinal linear contrast test (OLCT) (Zhang, A simple and efficient statistical approach for designing an early phase I作者: miracle 時(shí)間: 2025-3-28 06:58
Patient-Reported Tolerability in Oncology Drug Development for early-phase and late-phase trials, will be discussed. Issues that will be covered include dose optimisation in early-phase trials and the specification of tolerability endpoints and hypotheses in late-phase trials. We will also discuss key considerations when measuring tolerability in paediatri作者: Lipoprotein(A) 時(shí)間: 2025-3-28 10:33 作者: prick-test 時(shí)間: 2025-3-28 15:26 作者: fulmination 時(shí)間: 2025-3-28 19:45 作者: 輕快帶來(lái)危險(xiǎn) 時(shí)間: 2025-3-29 01:40
of novel approaches recently developed that follow the guiding principles of the initiative, some of which had been accepted by the Agency for implementation in real trials. Some regulatory perspectives with suggested analyses in the optimization data package and practical considerations related to作者: Exonerate 時(shí)間: 2025-3-29 04:53
Bits, Bytes, Words and Numbers,e dose of the study drug that can be used in later-phase trials. The traditional 3+3 design in oncology was used for many years to find the maximum tolerated dose (MTD) for chemotherapies. In recent years, several different model-based, model-assisted, and algorithm-based designs for dose finding ha作者: Mhc-Molecule 時(shí)間: 2025-3-29 09:13
Georgii Vladimirovich Rozenbergative analysis in terms of operating characteristics in simulation studies, and provide some recommendations to improve the practice. A new approach to improve the MTD determination by DLT weighting is also presented. Finally, some methods beyond DLT-based dose escalation designs are introduced to h作者: 譏諷 時(shí)間: 2025-3-29 11:34
Metastases to the Urogenital Systemle doses and select dose(s) to expand to a Phase 3 trial if expected efficacy is observed at an interim evaluation. Different variations of the 2-in-1 designs have been proposed, each incorporating distinct strategies of dose selection and testing. In this chapter, we reviewed different 2-in-1 desig作者: 反復(fù)無(wú)常 時(shí)間: 2025-3-29 18:20
https://doi.org/10.1007/978-1-4842-2114-3cussed in Li et al. (.. In .. ICSA Book Series in Statistics, pp. 285–299. Springer International Publishing Switzerland (2015)), the combined analysis may cause type I error inflation due to the correlation and dose selection. Sidák adjustment has been proposed to control the overall type I error b
