標(biāo)題: Titlebook: New Drug Development; An Introduction to C J. Rick Turner Book 2010Latest edition Springer Science+Business Media, LLC 2010 Clinical.Develo [打印本頁] 作者: microbe 時(shí)間: 2025-3-21 17:15
書目名稱New Drug Development影響因子(影響力)
書目名稱New Drug Development影響因子(影響力)學(xué)科排名
書目名稱New Drug Development網(wǎng)絡(luò)公開度
書目名稱New Drug Development網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱New Drug Development被引頻次
書目名稱New Drug Development被引頻次學(xué)科排名
書目名稱New Drug Development年度引用
書目名稱New Drug Development年度引用學(xué)科排名
書目名稱New Drug Development讀者反饋
書目名稱New Drug Development讀者反饋學(xué)科排名
作者: 代替 時(shí)間: 2025-3-21 20:22 作者: 罵人有污點(diǎn) 時(shí)間: 2025-3-22 01:57
New Drug Development,novel chemical compound, i.e., a new chemical entity (NCE) or new molecular entity (NME), as its active ingredient. In the case of biologicals, attention focuses on proteins that are produced via the large-scale cultivation of microbial or mammalian cells.作者: MELD 時(shí)間: 2025-3-22 06:21 作者: BOLUS 時(shí)間: 2025-3-22 08:52
Sample Size Estimation, an understanding of important concepts, including statistical significance and clinical significance, before reading about sample size estimation. Addressing sample size estimation at this point also allows a whole (short) chapter to be dedicated to this topic, thereby acknowledging its importance in clinical research.作者: 沉著 時(shí)間: 2025-3-22 14:46
Cardiac and Cardiovascular Safety Assessments,ng). In this chapter discussions focus on analogous evaluations in humans if a sponsor decides to move the drug molecule into clinical trials. At this point, the term investigational drug can be adopted.作者: 寡頭政治 時(shí)間: 2025-3-22 19:43 作者: ACE-inhibitor 時(shí)間: 2025-3-22 23:20 作者: Hemoptysis 時(shí)間: 2025-3-23 05:19
General Safety Assessments,cussions of safety now move to safety assessments in clinical trials. This chapter discusses general safety assessments, and Chapter 14 addresses specialized cardiac and cardiovascular safety assessments that have recently become critical components of new drug development. Postmarketing surveillance is discussed later in Chapter 16.作者: LUDE 時(shí)間: 2025-3-23 07:34
Manufacturing Small Molecule Drugs and Biologicals,l. Successfully producing the drug candidate for nonclinical testing and clinical trials and manufacturing the drug for postapproval marketing are critical. Moreover, their complexity and difficulty should not be underestimated.作者: dithiolethione 時(shí)間: 2025-3-23 13:31 作者: Cryptic 時(shí)間: 2025-3-23 15:11
introduction to statistics and illustrates its important rolNew Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidat作者: Triglyceride 時(shí)間: 2025-3-23 20:27
Book 2010Latest editionhis wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug mole作者: Banister 時(shí)間: 2025-3-24 01:44
http://image.papertrans.cn/n/image/665160.jpg作者: BLA 時(shí)間: 2025-3-24 04:20 作者: HEAVY 時(shí)間: 2025-3-24 09:44
Statistical Analysis,As noted in Chapter 1, Statistics can be thought of as an integrated discipline that includes several steps:作者: granite 時(shí)間: 2025-3-24 12:14 作者: 和平主義 時(shí)間: 2025-3-24 17:03
Nonclinical Research,egulatory governance, and reports of them are included in regulatory submissions requesting marketing approval. Three areas of investigation are considered here: pharmacokinetics, pharmacology, and toxicology. The scientific rationale of the studies is addressed, along with a summary of appropriate regulatory guidance.作者: 自然環(huán)境 時(shí)間: 2025-3-24 19:38
Designing Clinical Trials, design, conduct, and analysis impose artificial divisions on a process whose very nature is interactive and integrative. However, there is benefit in looking at components separately, since discussions can temporarily focus on one or two of them before illustrating the interrelatedness of all three. This chapter focuses on study design.作者: FLIT 時(shí)間: 2025-3-25 01:08
Efficacy Assessment,g approval, that is, it needs to have a favorable benefit–risk profile. Therapeutic benefit, operationalized as efficacy, is evaluated in therapeutic exploratory and therapeutic confirmatory trials, trials in which the subjects have the disease or condition of biological concern.作者: 宣誓書 時(shí)間: 2025-3-25 03:59 作者: 詞匯表 時(shí)間: 2025-3-25 10:54 作者: 牽索 時(shí)間: 2025-3-25 12:14
J. Rick TurnerDiscuss the latest developments in the realm of drug safety, and expands its coverage of clinical trials considerably Provides a conceptual introduction to statistics and illustrates its important rol作者: jungle 時(shí)間: 2025-3-25 19:30 作者: aesthetic 時(shí)間: 2025-3-25 23:12 作者: GLADE 時(shí)間: 2025-3-26 00:46 作者: Vulnerable 時(shí)間: 2025-3-26 06:43 作者: ALE 時(shí)間: 2025-3-26 10:25
Designing Clinical Trials, design, conduct, and analysis impose artificial divisions on a process whose very nature is interactive and integrative. However, there is benefit in looking at components separately, since discussions can temporarily focus on one or two of them before illustrating the interrelatedness of all three作者: 聯(lián)合 時(shí)間: 2025-3-26 14:13
Conducting Clinical Trials I: Experimental Methodology,gy and operational execution. This chapter discusses the former, and operational execution is discussed in the following chapter. Ideally, these components combine in a seamless fashion with the single goal of acquiring optimum quality data, i.e., numerical and descriptive representations of biologi作者: emulsify 時(shí)間: 2025-3-26 16:58
Conducting Clinical Trials II: Operational Execution,ng at a total of 100 investigational sites that are spread across several continents. Identifying potential subjects and then recruiting and retaining the required number is one challenge. Shipping the drug products for the clinical trial (the investigational and control drugs) to investigational si作者: 極小量 時(shí)間: 2025-3-26 22:46
Statistical Significance,ther group, and then see if the responses to the drug are, on average, different from those to the control. Providing a widely accepted answer to the question “Are the responses different?” requires framing the question in statistical language. Statistical techniques can then provide a quantitative 作者: Monocle 時(shí)間: 2025-3-27 03:07
Clinical Significance,) commented that “presenting .values alone can lead to them being given more merit than they deserve. In particular, there is a tendency to equate statistical significance with medical importance or biological relevance.” Statistical significance must not be equated with medical importance or biolog作者: poliosis 時(shí)間: 2025-3-27 08:47 作者: hysterectomy 時(shí)間: 2025-3-27 12:13
General Safety Assessments,ng surveillance. As noted in Chapter 3, in silico modeling in the discovery phase of synthetic drugs can examine the potential interactions of centers of reactivity in a drug with nontarget receptors, interactions that can lead to undesirable effects. Such studies are intended to modify the eventual作者: 證明無罪 時(shí)間: 2025-3-27 16:14
Efficacy Assessment,g approval, that is, it needs to have a favorable benefit–risk profile. Therapeutic benefit, operationalized as efficacy, is evaluated in therapeutic exploratory and therapeutic confirmatory trials, trials in which the subjects have the disease or condition of biological concern.作者: Accord 時(shí)間: 2025-3-27 21:38 作者: Diaphragm 時(shí)間: 2025-3-27 22:42
Manufacturing Small Molecule Drugs and Biologicals,odynamic profile, i.e., a profile that indicates it would interact successfully with its target receptor, will not be clinically useful if it does not reach the target receptor in the chemical state necessary to affect a response. Therefore, getting the drug to the microenvironment of the target rec作者: 繼而發(fā)生 時(shí)間: 2025-3-28 02:25
Postmarketing Surveillance,rs. These chapters have discussed “engineering safety” into new molecular entities, safety evaluations in nonclinical studies, and safety evaluations in clinical trials. Efficacy is also considered throughout the drug development process, particularly in the discovery phase and then again in therape作者: acetylcholine 時(shí)間: 2025-3-28 07:32
Main Themes and Concluding Comments,have been discussed individually in the preceding chapters, this final chapter takes a more global view. It brings together threads that have run throughout the individual chapters and presents an integrative summary of topics discussed to date. Following these summary discussions, several new topic作者: AXIOM 時(shí)間: 2025-3-28 10:34
izienter zu sein,. und wenn Marketing das . ist,. dann besteht eine wesentliche Aufgabenstellung einer Marketingstrategie darin, dem Nachfrager ein Angebot zu offerieren, das ihm mehr Nutzen verschafft als alle anderen von ihm in Erw?gung gezogenen Konkurrenzangebote. Bei dem Versuch, dieses Ziel zu作者: 勾引 時(shí)間: 2025-3-28 17:33 作者: conjunctivitis 時(shí)間: 2025-3-28 21:56 作者: 哀求 時(shí)間: 2025-3-28 23:06 作者: famine 時(shí)間: 2025-3-29 03:54 作者: VAN 時(shí)間: 2025-3-29 10:59 作者: Gratulate 時(shí)間: 2025-3-29 11:38 作者: 銀版照相 時(shí)間: 2025-3-29 15:36
its effectiveness. The central focus of the first edition of this book is captured by its subtitle, ‘Design, Methodology, and Analysis‘. Optimum quality study design and experimental research methodology must b978-1-4939-0091-6978-1-4419-6418-2作者: absorbed 時(shí)間: 2025-3-29 23:48
Failure of the Exchange,Council of State met to consider the question. Contrary to all expectation, Vergennes, after pointing out that the Netherlands, once independent of Austria, would certainly fall under the influence of France, announced his support of the exchange plan.. His ministerial colleagues, however, opposed i作者: Cupping 時(shí)間: 2025-3-30 00:15 作者: Dysarthria 時(shí)間: 2025-3-30 04:23
: A Study of Wages, Work and Welfare on Peruvian Sugar Plantationsg, electricity, drinking water and leisure facilities for their permanent labour force, as well as providing subsidized rations of food and clothing. The value of these benefits when added to a relatively high cash wage placed this group of workers in the top quartile of the country’s income earners作者: hauteur 時(shí)間: 2025-3-30 10:48
James D. Goldberg,Mitchell S. Golbus knew she would be able to help me figure out whether I did, indeed, have a methodological autobiography. We conducted four open-ended interviews structured around an academic life history. We transcribed the interviews and condensed those four interviews into this edited piece.—NR作者: Conflagration 時(shí)間: 2025-3-30 15:27 作者: 有惡意 時(shí)間: 2025-3-30 18:17 作者: 溫和女人 時(shí)間: 2025-3-30 23:09
https://doi.org/10.1057/9781137349408on, thus continuing the circle of poverty. Accordingly, our results suggest that Mexican child-brides spend, on average, 4 years less in formal education than their peers who married after the age of 18. Nine out of ten child-brides also give birth to a first child before the age of 20. Therefore, d作者: 友好關(guān)系 時(shí)間: 2025-3-31 01:10 作者: 終端 時(shí)間: 2025-3-31 05:41 作者: Hirsutism 時(shí)間: 2025-3-31 12:50
Tom Gallaghersses their relevance with regard to key issues in educational theory and practice. The third part shows how conceptual constellations based on Agamben’s work can inspire studious practices within the spatial, t978-3-030-02332-4978-3-030-02333-1Series ISSN 2211-1921 Series E-ISSN 2211-193X 作者: Crumple 時(shí)間: 2025-3-31 14:25 作者: COUCH 時(shí)間: 2025-3-31 18:04 作者: IST 時(shí)間: 2025-3-31 22:18
