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Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M最新文献

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Sample size considerations for establishing clinical bioequivalence of allergen formulations. 建立过敏原制剂临床生物等效性的样本量考虑。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Ronald L Rabin, Jay E Slater, Peter Lachenbruch, Richard W Pastor
{"title":"Sample size considerations for establishing clinical bioequivalence of allergen formulations.","authors":"Ronald L Rabin,&nbsp;Jay E Slater,&nbsp;Peter Lachenbruch,&nbsp;Richard W Pastor","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Bioequivalence of formulations must be established by proving that the differences between the formulations are within a specified interval according to Equation 1, the Interval Hypothesis. Explicit estimates of sample size determined from Equation 8 and listed in Table 1 are qualitatively larger than those that would be determined from Equation 2, the Hypothesis of No Difference. Equation 8 was derived from the TOST procedure; other valid methods should yield comparable results. In any context, this discussion has illustrated that the failure to demonstrate a difference is not sufficient to demonstrate equivalence, and that a properly powered equivalence study of allergen formulations will generally demand many more than four study subjects.</p>","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"24-33"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24497607","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
Approaches based on mutated or modified recombinant grass pollen allergens--in vivo evaluation of the constructs. 基于突变或修饰的重组草花粉过敏原的方法——构建物的体内评价。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Ute Lepp, Frank Eberhardt, Gabriele Schramm, Peter Zabel, Roland Suck, Hans Meyer, Helmut Fiebig, Oliver Cromwell, Wolf-Meinhard Becker
{"title":"Approaches based on mutated or modified recombinant grass pollen allergens--in vivo evaluation of the constructs.","authors":"Ute Lepp,&nbsp;Frank Eberhardt,&nbsp;Gabriele Schramm,&nbsp;Peter Zabel,&nbsp;Roland Suck,&nbsp;Hans Meyer,&nbsp;Helmut Fiebig,&nbsp;Oliver Cromwell,&nbsp;Wolf-Meinhard Becker","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"188-91"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496885","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
Recombinant mite allergens: validation strategies and clinical trials. 重组螨过敏原:验证策略和临床试验。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Martin D Chapman
{"title":"Recombinant mite allergens: validation strategies and clinical trials.","authors":"Martin D Chapman","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"205-10; discussion 210-2"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496888","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
Future aspects of regulation. 未来的监管方面。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Jay E Slater
{"title":"Future aspects of regulation.","authors":"Jay E Slater","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"34-9; discussion 39-41"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24497608","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
The CREATE project: a new beginning of allergen standardization based on mass units of major allergens. CREATE项目:基于主要过敏原质量单位的过敏原标准化的新开端。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Ronald van Ree
{"title":"The CREATE project: a new beginning of allergen standardization based on mass units of major allergens.","authors":"Ronald van Ree","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"70-3; discussion 74-5"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24497611","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
Preventive aspects of specific immunotherapy. 特异性免疫治疗的预防方面。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Lars Jacobsen
{"title":"Preventive aspects of specific immunotherapy.","authors":"Lars Jacobsen","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"141-5"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496878","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
Protection against infectious diseases by DNA-based vaccination strategies--lessons for allergy treatment? 基于dna的疫苗接种策略对传染病的保护——过敏治疗的经验教训?
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Jörg Schneider
{"title":"Protection against infectious diseases by DNA-based vaccination strategies--lessons for allergy treatment?","authors":"Jörg Schneider","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"300-3"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24497436","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
Mediator release assays based on human and murine IgE: potential and limitations in allergen standardization. 基于人和鼠IgE的介质释放测定:过敏原标准化的潜力和局限性。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2003-01-01
Andreas Hoffmann, Susanne Kaul, Kay Fötisch, Nicole Danz, Dirk Lüttkopf, Lina Hatahet, Birgit Kastner, Lothar Vogel, Gerhard Höltz, Stefan Vieths
{"title":"Mediator release assays based on human and murine IgE: potential and limitations in allergen standardization.","authors":"Andreas Hoffmann,&nbsp;Susanne Kaul,&nbsp;Kay Fötisch,&nbsp;Nicole Danz,&nbsp;Dirk Lüttkopf,&nbsp;Lina Hatahet,&nbsp;Birgit Kastner,&nbsp;Lothar Vogel,&nbsp;Gerhard Höltz,&nbsp;Stefan Vieths","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"76-85; discussion 85-6"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24497612","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
Biological standardization. 生物学上的标准化。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 1997-01-01
P C Turkeltaub
{"title":"Biological standardization.","authors":"P C Turkeltaub","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 91","pages":"145-56"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20312100","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
Recombinant house dust mite allergens. 重组屋尘螨过敏原。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 1997-01-01
W R Thomas, W Smith, B J Hales, M D Carter, B J Bennett, H D Shen, E R Tovey, K Y Chua
{"title":"Recombinant house dust mite allergens.","authors":"W R Thomas,&nbsp;W Smith,&nbsp;B J Hales,&nbsp;M D Carter,&nbsp;B J Bennett,&nbsp;H D Shen,&nbsp;E R Tovey,&nbsp;K Y Chua","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 91","pages":"87-94; discussion 94-6"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20312877","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
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