Clinical Endpoint Bioequivalence study [Regulatives / Guidelines]

posted by sury – India, 2019-04-08 15:29 (1930 d 20:45 ago) – Posting: # 20130
Views: 3,650

Hii all
Hope all are doing well!
I have recently got an bioequivalence study with clinical endpoints for some drug
In OGD it states that

“To establish bioequivalence, the 90% confidence interval of the test/reference ratio of the mean should be contained within [0.80, 1.25], using the per protocol (PP) population.”

The scores of the clinical endpoint shall be as follows
“Score the oral lesions and specific signs and symptoms of oropharyngeal candidiasis at each visit using the following two scoring systems:
  1. Oral lesions score (Murray scale)
    0=none
    1=single, localized
    2=multiple, localized
    3=extensive, confluent
  2. Signs and Symptoms score (e.g., erythema, thrush, mucositis, odynophagia, burning/soreness, xerostomia, modified taste, pharyngeal irritation)
    0=absent
    1=mild
    2=moderate
    3=severe”
For the above, do we need to convert the grading (0,1,2,3) to log transformed data and conduct the statistical analysis?

As the above states that 20% difference is accepted, then in normal bioequivalence case (if untransformed data), it should be 80.00-120.00?


Correct me if I am wrong?


Best regards

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