对含有佐剂的疫苗,抗原的吸附度对制品的效价会产生较大的影响,因此应测定成品的效力。效力试验应能证实组分间的相互作用使某一种组分对其他组分产生的英语翻译

对含有佐剂的疫苗,抗原的吸附度对制品的效价会产生较大的影响,因此应测定

对含有佐剂的疫苗,抗原的吸附度对制品的效价会产生较大的影响,因此应测定成品的效力。效力试验应能证实组分间的相互作用使某一种组分对其他组分产生增强或减弱作用。效力试验可以用动物免疫原性试验,对每一种抗原的免疫应答以及应答的质量都应进行研究,这些研究应当包括测定抗体的分类、亲和力、亲和性、抗体动态变化或功能,例如测定中和靶抗原或毒素的能力。最好是用动物试验比较联合疫苗与单个抗原的免疫应答情况,以确定是否发生了免疫应答的增强或抑制现象。同样,也应在动物免疫原性研究中测定活疫苗株之间的免疫干扰现象。对于一个新的疫苗或者联合疫苗中含有人体未曾使用过的新抗原,只要有动物模型,就应当首先用动物模型对其保护力进行研究。保护力试验应当采用拟预防疾病的有毒株来攻击。应当按照经统计学和经科学验证的试验步骤对试验结果进行确认,并应详细描述。此项试验应在产品的开发早期进行。
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结果 (英语) 1: [复制]
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For vaccines containing adjuvants, the degree of antigen adsorption has a greater impact on the potency of the product, so the efficacy of the finished product should be determined. <br>The effectiveness test should be able to confirm that the interaction between the components makes a certain component have a strengthening or weakening effect on other components. <br>The efficacy test can use animal immunogenicity test. The immune response of each antigen and the quality of the response should be studied. These studies should include the determination of antibody classification, affinity, affinity, antibody dynamic changes or function, such as The ability to neutralize target antigens or toxins. <br>It is best to use animal experiments to compare the immune response of the combined vaccine with a single antigen to determine whether an enhancement or suppression of the immune response has occurred. <br>Similarly, the phenomenon of immune interference between live vaccine strains should also be measured in animal immunogenicity studies. <br>For a new vaccine or combination vaccine that contains new antigens that have not been used in humans, as long as there is an animal model, the animal model should first be used to study its protection. <br>Protection tests should use virulent strains that are intended to prevent diseases. <br>The test results should be confirmed in accordance with statistical and scientifically verified test procedures, and should be described in detail. <br>This test should be carried out early in the development of the product.
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结果 (英语) 2:[复制]
复制成功!
For vaccines containing adages, the adsorption of antigens will have a greater impact on the price of the product, so the effectiveness of the finished product should be determined.<br>The effectiveness test should be able to prove that the interaction between components enhances or weakens one component over another.<br>Effectiveness tests can be conducted using animal immunogenic tests to study the immune response and the quality of each antigen, and these studies should include the determination of the classification, affinity, affinity, dynamic changes or functions of antibodies, such as the ability to neutralize target antigens or toxins.<br>It is best to compare the immune response of a combined vaccine with a single antigen with animal trials to determine whether an enhanced or inhibited immune response has occurred.<br>Similarly, immune interference between live vaccine strains should be measured in animal immunogenic studies.<br>For a new vaccine or a combined vaccine that contains new antigens that have not been used by the human body, animal models should be used first to study their conservation.<br>Protection tests should be attacked with toxic strains intended to prevent disease.<br>The results of the experiments shall be confirmed in accordance with statistically and scientifically validated test steps and shall be described in detail.<br>This test should be carried out early in the development of the product.
正在翻译中..
结果 (英语) 3:[复制]
复制成功!
For the vaccine containing adjuvant, the antigen adsorption degree has a great influence on the potency of the product, so the potency of the finished product should be determined.<br>The interaction of one component with another should be confirmed to be more effective.<br>Animal immunogenicity test can be used for potency test. The immune response of each antigen and the quality of response should be studied. These studies should include the determination of antibody classification, affinity, affinity, dynamic changes or function of antibody, such as the ability to neutralize target antigen or toxin.<br>It is better to compare the immune response of the combined vaccine with that of the single antigen by animal test to determine whether the immune response is enhanced or suppressed.<br>Similarly, immune interference between live vaccine strains should also be measured in animal immunogenicity studies.<br>As long as there are animal models in a new vaccine or combined vaccine containing new antigens that have never been used by human body, we should first use animal models to study their protection.<br>The protective test should be carried out with the virulent strain to prevent the disease.<br>The test results should be confirmed according to the statistical and scientifically verified test procedures, and should be described in detail.<br>This test should be carried out in the early stage of product development.<br>
正在翻译中..
 
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