標(biāo)題: Titlebook: Genotoxicity and Carcinogenicity Testing of Pharmaceuticals; Michael J. Graziano,David Jacobson-Kram Book 2015 Springer International Publ [打印本頁(yè)] 作者: Boldfaced 時(shí)間: 2025-3-21 17:25
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書目名稱Genotoxicity and Carcinogenicity Testing of Pharmaceuticals被引頻次
書目名稱Genotoxicity and Carcinogenicity Testing of Pharmaceuticals被引頻次學(xué)科排名
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書目名稱Genotoxicity and Carcinogenicity Testing of Pharmaceuticals讀者反饋學(xué)科排名
作者: 震驚 時(shí)間: 2025-3-21 20:36 作者: SCORE 時(shí)間: 2025-3-22 01:19
Genotoxicity Testing of API,est results usually have severe ramifications with APIs dropped from further development. While negative results in the appropriate follow-up tests (e.g., mouse carcinogenicity studies) could enable progression of API development, pragmatically the cost and long duration required for these tests mea作者: curettage 時(shí)間: 2025-3-22 05:20 作者: 肉體 時(shí)間: 2025-3-22 12:46 作者: aviator 時(shí)間: 2025-3-22 14:06 作者: aviator 時(shí)間: 2025-3-22 19:39
Carcinogenicity Testing Strategies for Small Molecules,le pharmaceuticals. Testing strategies for biologic molecules is beyond the scope and the reader is referred to Chap. 8 by Dempster et al. In this chapter a brief history of pharmaceutical carcinogenicity testing is summarized that describes the path of evolution to our current state. The current st作者: Extemporize 時(shí)間: 2025-3-22 23:04 作者: blackout 時(shí)間: 2025-3-23 04:19 作者: allergy 時(shí)間: 2025-3-23 06:35
Nonclinical Strategies for Investigating Potential Tumor Signals Detected in Clinical Trials, of evidence of a carcinogenic risk in nonclinical studies. It is always possible that, given the small numbers of patients in clinical trials, such signals may be due to chance or, for example, ascertainment bias; however, any signal of potential treatment-related malignancy must be evaluated and p作者: OASIS 時(shí)間: 2025-3-23 10:55 作者: Abduct 時(shí)間: 2025-3-23 17:56 作者: 抓住他投降 時(shí)間: 2025-3-23 20:49
enotoxicity and carcinogenicity tests.Written by well recogn.This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous cas作者: Opponent 時(shí)間: 2025-3-23 23:14
Book 2015es of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. .With contributions from recognized experts作者: 離開可分裂 時(shí)間: 2025-3-24 02:25
Book 2015s, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.?.作者: ANTH 時(shí)間: 2025-3-24 06:31
https://doi.org/10.1007/978-3-322-98859-1 of findings in the animal studies. This book focuses on these topics in an integrated way, taking into account the rapid advances in safety sciences and evolving regulatory requirements. The book is written by well recognized experts from the pharmaceutical industry and US and European health autho作者: invade 時(shí)間: 2025-3-24 13:33
https://doi.org/10.1007/978-3-658-09856-8sessment that relies only on knowledge of chemical structure to provide a prediction, making them inexpensive and rapid to apply without the need for synthesis of the potential drug candidate. Toxicogenomic-based approaches aim to assess biological functions based on interactions among various parts作者: Aqueous-Humor 時(shí)間: 2025-3-24 17:33 作者: 報(bào)復(fù) 時(shí)間: 2025-3-24 18:59 作者: Esalate 時(shí)間: 2025-3-25 00:05
Die Bedingungen für eine gute Regulirung in vivo . gene mutation assay, and the liver micronucleus (MN) assay. An established test, the transgenic rodent (TGR) gene mutation assay, is presented as a test whose use for regulatory decision-making may increase due to the recent introduction of robust testing protocols and new test guidelines作者: 符合國(guó)情 時(shí)間: 2025-3-25 03:47 作者: 鳴叫 時(shí)間: 2025-3-25 10:07 作者: Indelible 時(shí)間: 2025-3-25 14:52 作者: 旁觀者 時(shí)間: 2025-3-25 17:48
Heinrich Reploh,Hans-Jürgen Otter, some nonclinical models to study tumor promotion and progression are discussed, and case studies are presented to illustrate various courses of follow-up investigations. Development and validation of innovative models for assessing tumor promotion and progression that are more human-based warrant作者: KIN 時(shí)間: 2025-3-25 23:29
tudies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.?.978-3-319-22083-3978-3-319-22084-0作者: opprobrious 時(shí)間: 2025-3-26 00:09
Introduction: An Overview of Industry and Regulatory Perspectives on the Genotoxic and Carcinogenic of findings in the animal studies. This book focuses on these topics in an integrated way, taking into account the rapid advances in safety sciences and evolving regulatory requirements. The book is written by well recognized experts from the pharmaceutical industry and US and European health autho作者: Obloquy 時(shí)間: 2025-3-26 07:23 作者: inundate 時(shí)間: 2025-3-26 08:35 作者: FUME 時(shí)間: 2025-3-26 16:04
Genotoxic Impurities in Pharmaceuticals, Further, a few examples are given on how to deal with potential impurities with mutagenic/carcinogenic potential or for compounds for such a potential is assumed but not demonstrated. Hence, in the following chapter, the reader can expect some background information about the ICH M7 guideline and t作者: Muscularis 時(shí)間: 2025-3-26 17:51
New and Emerging Genetic Toxicity Tests and Approaches to Genetic Toxicology Testing, in vivo . gene mutation assay, and the liver micronucleus (MN) assay. An established test, the transgenic rodent (TGR) gene mutation assay, is presented as a test whose use for regulatory decision-making may increase due to the recent introduction of robust testing protocols and new test guidelines作者: evince 時(shí)間: 2025-3-26 23:26
Carcinogenicity Testing Strategies for Small Molecules,oaches are successfully deployed by industry scientists to support conclusions that positive rodent carcinogenicity study outcomes are related to compound class effects and are not human relevant, and examples are provided where product marketing has been enabled. Finally based on decades of such re作者: olfction 時(shí)間: 2025-3-27 03:21 作者: Antagonism 時(shí)間: 2025-3-27 07:30 作者: Vo2-Max 時(shí)間: 2025-3-27 13:13
Nonclinical Strategies for Investigating Potential Tumor Signals Detected in Clinical Trials,r, some nonclinical models to study tumor promotion and progression are discussed, and case studies are presented to illustrate various courses of follow-up investigations. Development and validation of innovative models for assessing tumor promotion and progression that are more human-based warrant作者: abject 時(shí)間: 2025-3-27 17:34 作者: TIA742 時(shí)間: 2025-3-27 20:57 作者: choleretic 時(shí)間: 2025-3-28 00:32
https://doi.org/10.1007/978-3-319-22084-0Carcinogenicity; Genotoxicity; Immunomodulators; In Silico Predictive Tests; Regulatory; Tumor Signals作者: 衍生 時(shí)間: 2025-3-28 04:11 作者: 配偶 時(shí)間: 2025-3-28 09:35 作者: seroma 時(shí)間: 2025-3-28 13:10 作者: SPASM 時(shí)間: 2025-3-28 16:18 作者: 教義 時(shí)間: 2025-3-28 21:15 作者: TOXIN 時(shí)間: 2025-3-28 23:32
Ritualforschung und Ritualtheorien,th effects especially related to impurities in drug substances or drug products. While ICH guidelines for “ordinary” impurities have been available for many years, a harmonized guideline on how to assess, limit and control potential health effects of low levels of genotoxic/carcinogenic impurities w作者: Overthrow 時(shí)間: 2025-3-29 06:15
Die Bedingungen für eine gute Regulirungue in predicting its carcinogenic potential. For new pharmaceuticals, test data from a standard test battery are required prior to administering the compound to humans. This test battery includes in vivo studies of chromosomal damage in the rodent hematopoietic system, traditionally performed in the作者: 歹徒 時(shí)間: 2025-3-29 09:36 作者: GRIN 時(shí)間: 2025-3-29 12:12 作者: GUILT 時(shí)間: 2025-3-29 18:09 作者: Enrage 時(shí)間: 2025-3-29 20:29
