pravin17
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India,
2013-05-31 15:59
(4772 d 08:18 ago)

Posting: # 10697
Views: 2,788
 

 Emesis criteria for modified formulation [Regulatives / Guidelines]

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Please guide for determining emesis criteria for 800 mg DR capsule, as per labeled dosing interval mentioned on SPC is like
  1. The treatment of mildly to moderately active 800 mg three times daily (2.4 grams total daily dosing)
  2. PK details Tmax 12 hours and T1/2 4-16 hours.
Thank you in advance!
Pravin
 
Helmut
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Vienna, Austria,
2013-05-31 16:12
(4772 d 08:05 ago)

@ pravin17
Posting: # 10699
Views: 2,237
 

 Special case DR

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Hi Pravin,

[image] FDA states:

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. In the case of modified-release products, the data from subjects who expe­ri­ence emesis any time during the labeled dosing interval can be deleted.

In the case of a DR product where tmax ≥ τ the absorption mainly is dependent on the (intrinsically variable) gastric emptying. I would strongly suggest to exclude subjects who vomited within 24 hours.
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