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
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
Complete thread:
- PK Parameters for Bioequivalent Criteriaomprakash 2017-01-23 12:21 [Regulatives / Guidelines]
- PK Parameters for Bioequivalent Criteria Dr_Dan 2017-01-23 13:32
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
- PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
- Australia’s = EMA’s MR guideline Helmut 2017-02-04 18:25
- Australia’s = EMA’s MR guideline Muthu Raj 2017-02-06 12:01
- Australia’s = EMA’s MR guideline Helmut 2017-02-04 18:25
- PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
- PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
- PK Parameters for Bioequivalent Criteria Dr_Dan 2017-01-23 13:32