重组和改良过敏原:美国的观点。

Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M Pub Date : 2006-01-01

Ronald L Rabin

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摘要

由于过敏原性和抗原性(效力)不再等同，因此必须科学地证明修改的合理性，并证明(a)通过标准方法失去过敏原性，(b)动物和临床研究的效力，以及临床疗效的替代标记，以及(c)生化和生物学稳定性。

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Recombinant and modified allergens: the U.S. perspective.

Since allergenicity and antigenicity (potency) are no longer equivalent, one must scientifically justify modifications and demonstrate (a) loss of allergenicity by standard methods, (b) potency with animal and clinical studies, as well as surrogate markers for clinical efficacy, and (c) biochemical and biologic stability.

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

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