IR and MR: pre-specified! [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-07-22 17:33 (2441 d 23:28 ago) – Posting: # 17594
Views: 5,912

Hi Mahesh,

❝ If any subject vomit between the day 1-2 and 1-4, what will be the withdrawal criteria? If steady state achive in three days and emesis occur on day one or day two should we continue the subjects.


Depends on the formulation. I apply the same rules like in a SD study but irrespective whether emesis occurs in the saturation phase or on a profile day.FDA:

We recommend that data from subjects who experience emesis during the course of a BE study for immediate release products be deleted from statistical analysis if vomiting occurs at or before 2 times median Tmax. For modified release products, we recommend deleting data from the analysis if a subject vomits during a period of time less than or equal to the dosing interval stated in the labeling of the product.

EMA:

Examples of reasons to exclude the results from a subject in a particular period are events such as vomiting […] which could render the plasma concentration-time profile unreliable.
The permitted reasons for exclusion must be pre-specified in the protocol. If one of these events occurs it should be noted in the CRF as the study is being conducted. Exclusion of subjects based on these pre-spe­ci­fied criteria should be clearly described and listed in the study report.


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