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Back to the forum  Query: 2017-06-24 22:48 CEST (UTC+2h)
 
omprakash
Junior

India,
2017-01-23 12:21

Posting: # 16993
Views: 1,457
 

 PK Parameters for Bioequivalent Criteria [Regulatives / Guidelines]

Dear Sir,

We have developed Paracetamol Sr 665mg tablets (Unilayer) versus Panadol 665mg tablets (bilayer, 31% IR + 69% SR).

Then what will be the primary PK parameters for Bio-equivalent criteria. Whether Cmax also compulsory to meet Bio-equivalent criteria then what will be the acceptance criteria. OR Only AUC is required as Bio-equivalent criteria?

Regards,

Om Prakash
Dr_Dan
Senior

2017-01-23 13:32

@ omprakash
Posting: # 16994
Views: 1,279
 

 PK Parameters for Bioequivalent Criteria

Dear Om Prakash
To state which primary PK Parameters you need you need to know which territory is planned for submission (US, Europe, …).
However in each case you do not only show bioequivalence for Cmax but at least also for AUC (Cmin, partialAUC, … etc.). In General acceptance criteria 80 – 125% unless intraindividual variability allows to widen the acceptance range.

Kind regards and have a nice day
Dr_Dan
omprakash
Junior

India,
2017-01-28 07:17

@ Dr_Dan
Posting: # 16997
Views: 1,046
 

 PK Parameters for Bioequivalent Criteria

» … which territory is planned for submission (US, Europe, …).

Dear Sir,

I have planned separate study for submission Australia and European union.

Thanks,

Om Prakash


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Muthu Raj
Junior

Tamilnadu, India,
2017-02-04 12:58

@ omprakash
Posting: # 17012
Views: 877
 

 PK Parameters for Bioequivalent Criteria

Dear Sir,

The European Union guidelines adopted in Australia
Primary PK Parameter: AUC0-t and Cmax
Secondary PK Parameter: Tmax

Muthu Raj
Helmut
Hero
Homepage
Vienna, Austria,
2017-02-04 18:25

@ Muthu Raj
Posting: # 17013
Views: 875
 

 Australia’s = EMA’s MR guideline

Hi Muthu Raj,

» The European Union guidelines adopted in Australia
» Primary PK Parameter: AUC0-t and Cmax
» Secondary PK Parameter: Tmax

Here you err. Om Prakash is dealing with a modified-release product. Hence, the respective guideline should be observed (as mentioned by Dan above).

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Muthu Raj
Junior

Tamilnadu, India,
2017-02-06 12:01

@ Helmut
Posting: # 17018
Views: 814
 

 Australia’s = EMA’s MR guideline

Hi Sir,

Thanks for this Information

Muthu Raj
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