请完成如下试译回站内（可选择最擅长的一篇试译，如果都擅长就试译两篇），并附上电话与电子邮箱，谢谢
价格60元/千中文，按字数统计第二行计算
药学：
The process validation studies demonstrate the removal of process-related impurities. Limits for purity have been established and justified based upon preclinical, clinical or manufacturing experience with Basiliximab and in accordance with the World health organization (WHO), FDA guidance documents and ICH guidelines. Here, process validation studies from the proposed manufacturing site, Huningue, are shown.

To estimate the purity of Basiliximab, the impurities, variants and potential contaminates in the DS have been evaluated based on the definitions given below.

The absolute purity is difficult to determine and depends on the methods used.  Historically, the relative purity of a biological product has been expressed in terms of specific activity, i.e., the amount of biological activity per milligram of protein. Since this value also depends on the methods used, the purity of a product is estimated by a combination of several different methods. An inherent degree of structural heterogeneity occurs in proteins due to the biosynthetic processes used by living organisms that produce them. As such, the drug substance can include several molecular entities or variants. When these molecular entities are derived from anticipated post-translational modifications, they may be considered as part of the desired product.
临床
The subject may withdraw at will at any time. Please see section 8.1.7 for procedure to be performed in case of subject withdrawal.
Subjects should stay in the trial irrespective of lack of adherence to randomised treatment, lack of adherence to visit schedule, missing assessments, trial product discontinuation due to AE (see section 6.5.1), unwillingness to cope with injection regimen, development of co-morbidities or clinical outcomes.
A subject who agrees to provide information concerning morbidities which are relevant for the assessments of cardiovascular outcomes and/or other trial end-points at the planned end of the trial should not be considered withdrawn from the trial.
Subjects who consider withdrawing from the trial should as a minimum be encouraged to have procedures performed according to the end of treatment visit(V9) and the follow up visit(V10), please see 8.1.7.
Only subjects who decline any further contact with the site in relation to the trial, and hence do not agree to report information which is relevant for the assessments of cardiovascular outcomes and/or other trial end-points at the end of trial should be considered as withdrawn from the trial.
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修改:daochukankan FROM 122.236.21.*
FROM 122.236.21.*