FAQ
Drugs

Currently in the EMA and USFDA bioanalytical guidelines, for the analysis of bioassays in some kinds of studies, an additional requirement to perform Incurred sample reanalysis (ISR) is required. How to perform the ISR and is it also required in Taiwan?

刊登日期:2019-11-12  |  點閱次數 : 343 次 

ISR is conducted by repeating the analysis of a subset of samples from a given study in separate runs. Objective criteria for choosing the subset of study samples for ISR should be predefined in the protocol, study plan or an SOP. It is recommended that samples for ISR be chosen around the Cmax and some in the elimination phase. If the total number of study samples is less than 1000, then 10% of the samples should be reanalysed; if the total number of samples is greater than 1000, then 10% of the first 1000 samples (100) plus 5% of the number of samples that exceed 1000 samples should be assessed. QC and calibration samples should be included in the ISR analysis run. For chromatographic methods, the percent difference should be ≤ 20% for at least 67 % of the repeats. In case of ligand binding assays, the percent difference should be within ±30% for at least 67 % of the repeats.

Currently there is no formal request for ISR in Taiwan. However, ISR is an international review requirement. ICH M10 is also included in this requirement. It is recommended that ISR should be performed at least in the following situations

  1. all pivotal bioequivalence/comparative bioavailability trials
  2. first clinical in human
  3. first clinical trial in patient subjects

ISR methods and results should be included in the study protocol and report for registration rev

 

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