PK Parameters for Bioequivalent Criteria [Regulatives / Guidelines]

posted by omprakash – India, 2017-01-23 13:21 (2942 d 18:04 ago) – Posting: # 16993
Views: 7,219

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

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