Tina
★    

India,
2014-05-01 12:28
(4088 d 00:06 ago)

Posting: # 12906
Views: 4,044
 

 Changes in halflife [Study As­sess­ment]

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Dear forum members,

In a recent MR study conducted, we found changes in half life between the reference and test MR formulations. The test was conducted in healthy volunteers.

Please help with the below:
  1. Would changes in release of the active by the formulations (MR in particular)affect half-life? AUC was considerably lower in the test despite the high half life observed against the reference formulation.
  2. What are the causes of failing to establish BE in Ctau (if other parameters have established BE)?
  3. If the strength developed is X but the posology says 2X dosing at a single time, should BE study be conducted with a dose of X or 2X?
The study was conducted for EU submission.

Kind regards,
Tina

Edit: Category changed. [Helmut]
 
Mahesh M
★    

India,
2014-05-03 09:20
(4086 d 03:14 ago)

(edited on 2014-05-03 09:46)
@ Tina
Posting: # 12910
Views: 3,166
 

 Changes in halflife

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Dear Tina,

❝ If the strength developed is X but the posology says 2X dosing at a single time, should BE study be conducted with a dose of X or 2X?

  1. Generally, the highest-marketed strength can be administered as a single unit. If warranted to achieve sufficient bioanalytical sensitivity, multiple units of the highest strength can be administered, provided the total single dose remains within the labeled dose range and the total dose is safe for administration to the study subjects.
  2. The objective of BE study is not to determine efficacy of the product.
  3. Ethical point of view if demonstration of BE (Not issue on bioanalytical method) is possible on single tablet then you can’t give two or multiples of tablets to healthy subjects although multiple of tablets are tolerable or safe.
So not go throw the recommended dose (Therapeutic dose) for BE study.
Regards
M
 
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