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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

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.

根据公式1的区间假设，必须通过证明公式之间的差异在指定的区间内来建立配方的生物等效性。从表1中列出的公式8确定的样本数量的显式估计值在质量上大于从公式2(无差异假设)确定的估计值。公式8由TOST程序导出;其他有效的方法应该产生类似的结果。在任何情况下，这一讨论都表明，未能证明差异不足以证明等效性，而对过敏原配方进行适当的等效性研究通常需要四个以上的研究对象。
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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
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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
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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
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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
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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
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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
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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
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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
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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
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引用次数: 0
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