Drop out handling in Europe Submission Study [Regulatives / Guidelines]

posted by pash413 – India, 2012-03-28 18:04 (4200 d 06:03 ago) – Posting: # 8343
Views: 5,582

Dear All
We are planing to conduct biostudy for EU submission and we need some clarity regarding below mentioned points:
  1. As per current EU guideline statistical evaluation of Tmax is not require, if our drug is not rapid release formulation. In old guidance it was mentioned as “if appropriate to the evaluation the analysis technique for Tmax should be non-parametric and should be applied to un-transformed data”.
    Is it required to performed statistical evaluation of Tmax in studies conducted after implementation of new guideline? Our formulation is not rapid release formulation.
  2. If during conduction of two way crossover bio study some of the subject(S) withdraw or dropped before check-in of period 2 but they had completed period 1 successfully.
    As pr current EU Guidance "Drop-out and withdrawal of subjects should be fully documented. If available, concentration data and pharmacokinetic parameters from such subjects should be presented in the individual listings, but should not be included in the summary statistics". and as per old guidance "All the results should be clearly presented and should include data from subjects who eventually dropped-out. Drop-out and withdrawal subjects should be fully documented and accounted for".

Should we have to analyze (bioanalysis) plasma samples of that dropped/withdraw subject(s)? We are confusing with the statement of current guidance "if available...."

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