If an alternative analytical procedure is submitted , the applicant should provide a rationale for its inclusion and identify its use ( e . g . , release , stability testing ) , validation data , and comparative data to the regulatory analytical procedure 如果提交了替代分析方法,申請者還應(yīng)當提供其理由,并標明其用途(如,放行,穩(wěn)定性實驗) ,驗證資料及其與法定分析方法的對比資料。