Ernst Schering Research Foundation workshop最新文献_第2页

Experiences with dose finding in patients in early drug development: the use of biomarkers in early decision making. 早期药物开发中患者剂量发现的经验:生物标志物在早期决策中的使用。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_5

S R Sultana, S Marshall, J Davis, B H Littman

引用次数: 5

Current stumbling blocks in oncology drug development. 目前肿瘤药物开发的绊脚石。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_10

C D Gimmi

引用次数: 3

Pharmacological prerequisites for PET ligands and practical issues in preclinical PET research. PET配体的药理学前提和临床前PET研究中的实际问题。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49527-7_12

S M Ametamey, M Honer

引用次数: 7

Integration of pediatric aspects into the general drug development process. 将儿科方面纳入一般药物开发过程。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_9

K Rose

{"title":"Integration of pediatric aspects into the general drug development process.","authors":"K Rose","doi":"10.1007/978-3-540-49529-1_9","DOIUrl":"https://doi.org/10.1007/978-3-540-49529-1_9","url":null,"abstract":"Drug treatment of children is today less regularly based on formal clinical testing than adults. This has led to concerns regarding the safety and efficacy of pediatric medicines and resulted in public action in the United States and the European Union. The reasons for the increasing awareness include better understanding of child physiology, increased trust in GCP (good clinical practice), improved treatment of several severe childhood diseases, a changed view of the child as a subject in society, and more. The US has successfully introduced pediatric legislation that facilitates participation of children in phar maceutical innovation, and comparable approaches are now being discussed in Europe and Japan. While the outcome of the EU pediatric regulation in the near future is still open, the US pediatric legislation has been highly successful over the past 8 years and will be revised before it expires in September 2007. Innovative drugs are today being developed by global pharmaceutical companies. Adding pediatric aspects to this development process is a complex task where companies need to build up internal competency. Bureaucratic procedures that could be harmful to the companies' economic fundaments need to be avoided, and an appropriate ethical framework is required. This needs to be addressed by all partners in healthcare, including regulatory authorities, the pharmaceutical industry, pediatricians, patients and others in a sense of shared responsibility.","PeriodicalId":80277,"journal":{"name":"Ernst Schering Research Foundation workshop","volume":" 59","pages":"123-34"},"PeriodicalIF":0.0,"publicationDate":"2007-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/978-3-540-49529-1_9","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26374688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Ethnic aspects of cancer trials in Asia. 亚洲癌症试验的种族因素。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_12

T W T Leung

引用次数: 2

Network genomics. 网络基因组学。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-31339-7_5

T E Ideker

{"title":"Network genomics.","authors":"T E Ideker","doi":"10.1007/978-3-540-31339-7_5","DOIUrl":"https://doi.org/10.1007/978-3-540-31339-7_5","url":null,"abstract":"Network genomics is an emerging area of bioengineering which models the influence of genes (hence, genomics) in the context of a larger biomolecular system or network. A biomolecular network is a comprehensive collection of molecules and molecular interactions that regulate cellular function. Molecular interactions include physical binding events between proteins and proteins, proteins and DNA, or proteins and drugs, as well as genetic relationships dictating how genes combine to cause particular phenotypes. Thinking about biological systems as networks goes hand-in-hand with our ability to experimentally measure and define biomolecular interactions at large scale. Once we have catalogued all of the interactions present in a network, we may begin to ask questions such as: How many different molecules are bound by a typical protein? What is the topological structure of the network? How are signals transmitted through the network in response to internal and external events? Which parts of the network are evolutionarily conserved across species, and which parts differ? Perhaps most importantly, we can begin to use the interaction network as a storehouse of information from which to extract and construct computer-based models of cellular processes and disease.","PeriodicalId":80277,"journal":{"name":"Ernst Schering Research Foundation workshop","volume":" 61","pages":"89-115"},"PeriodicalIF":0.0,"publicationDate":"2007-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/978-3-540-31339-7_5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26510661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[18F]fluoropyridines: From conventional radiotracers to the labeling of macromolecules such as proteins and oligonucleotides. [18F]氟吡啶:从传统的放射性示踪剂到大分子如蛋白质和寡核苷酸的标记。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49527-7_5

F Dollé

{"title":"[18F]fluoropyridines: From conventional radiotracers to the labeling of macromolecules such as proteins and oligonucleotides.","authors":"F Dollé","doi":"10.1007/978-3-540-49527-7_5","DOIUrl":"https://doi.org/10.1007/978-3-540-49527-7_5","url":null,"abstract":"Molecular in vivo imaging with the high-resolution and sensitive positron emission tomography (PET) technique requires the preparation of a positron-emitting radiolabeled probe or radiotracer. For this purpose, fluorine-18 is becoming increasingly the radionuclide of choice due to its adequate physical and nuclear characteristics, and also because of the successful use in clinical oncology of 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG), which is currently the most widely used PET-radiopharmaceutical and probably the driving force behind the growing availability and interest for this positron-emitter in radiopharmaceutical chemistry. With a few exceptions, radiofluorinations involving fluorine-18 of high specific radioactivity (e.g. > 185 GBq/micromole) had, until recently, been limited to nucleophilic substitutions in homoaromatic and aliphatic series with [18F]fluoride. Considering chemical structures showing a fluoropyridinyl moiety, nucleophilic heteroaromatic substitution at the ortho-position with no-carrier-added [l8F]fluoride, as its K[18F]F-K222 complex, appears today as a highly efficient method for the radiosynthesis of radiotracers and radiopharmaceuticals. This chapter summarizes the recent applications of this methodology and highlights its potential in the design and preparation of, often drug-based, fluorine-18-labeled probes of high specific radioactivity for PET imaging, including macromolecules of biological interest such as peptides, proteins and oligonucleotides.","PeriodicalId":80277,"journal":{"name":"Ernst Schering Research Foundation workshop","volume":" 62","pages":"113-57"},"PeriodicalIF":0.0,"publicationDate":"2007-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/978-3-540-49527-7_5","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26446664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 23

Dose finding in pediatric patients. 儿科患者的剂量发现。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_8

G Henze

{"title":"Dose finding in pediatric patients.","authors":"G Henze","doi":"10.1007/978-3-540-49529-1_8","DOIUrl":"https://doi.org/10.1007/978-3-540-49529-1_8","url":null,"abstract":"It is generally agreed that satisfactory safety and effectiveness of pharmaceutical products for children and adolescents have not yet been established. This applies in particular to anti-cancer drugs and even to those having successfully been used for many years in multidrug chemotherapy protocols for childhood cancer. For example, nephroblastoma or Wilms' tumor is one of the typical and frequent forms of childhood cancer occurring at a median age of about 3 years. Standard therapy for Wilms' tumor is the combination of vincristine and actinomycin D; survival is about 85%. For actinomycin D, the summary of product characteristics states that one contraindication is children aged below 6-12 months. If this would be considered and respected it would mean that a substantial proportion of children with Wilms' tumor would not be treated and thus a proven curative therapy would be withheld. The current situation in pediatrics is that off-label use has become a common practice: in private practice about 20% of prescriptions are off-label, in children's hospitals approximately 40%-50% with 50%-70% in pediatric oncology and more than 90% in neonatology (Conroy et al. 1999, 2000, 2003; Turner et al. 1996, 1998; McIntyre et al. 2000). These conditions are more or less tolerated by the authorities although they are beyond legality. The reason is that appropriate clinical trials like those in adults have not been conducted in children and drugs have therefore not been licensed.","PeriodicalId":80277,"journal":{"name":"Ernst Schering Research Foundation workshop","volume":" 59","pages":"111-21"},"PeriodicalIF":0.0,"publicationDate":"2007-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/978-3-540-49529-1_8","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26374687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4

Exploratory IND: a new regulatory strategy for early clinical drug development in the United States. 探索性IND:美国早期临床药物开发的新监管策略。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_11

N Sarapa

{"title":"Exploratory IND: a new regulatory strategy for early clinical drug development in the United States.","authors":"N Sarapa","doi":"10.1007/978-3-540-49529-1_11","DOIUrl":"https://doi.org/10.1007/978-3-540-49529-1_11","url":null,"abstract":"Optimizing exploratory drug development by means of doing first-in-human studies earlier is an attractive option for pharmaceutical sponsors to select more successful drug candidates. Traditional registration-driven clinical phase 1 programs could be preceded by early human screening studies with subpharmacological single doses (microdoses) or with low pharmacologically active doses of one or several lead candidates, whereby human pharmacokinetic and pharmacodynamic data are generated very early. Such low doses are not expected to have clinically significant toxic potential, so early human screening studies may be supported by abbreviated nonclinical safety packages. Recent U.S. FDA draft guidance (April 2005) regulated early human screening studies conducted under the exploratory IND. The author outlines the features of the study design, dose selection, and nonclinical safety packages required in support of exploratory IND studies in humans. In appropriately chosen cases, exploratory IND could allow for patients' quicker access to safer and more efficacious doses of novel drugs, reduce attrition in clinical trials, and facilitate more economical drug development.","PeriodicalId":80277,"journal":{"name":"Ernst Schering Research Foundation workshop","volume":" 59","pages":"151-63"},"PeriodicalIF":0.0,"publicationDate":"2007-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/978-3-540-49529-1_11","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26374690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 9

Smarter candidate selection--utilizing microdosing in exploratory clinical studies. 更明智的候选人选择-在探索性临床研究中利用微剂量。

Ernst Schering Research Foundation workshop Pub Date : 2007-01-01 DOI: 10.1007/978-3-540-49529-1_2

P Buchan

引用次数: 13