omprakash ☆ India, 2017-01-23 13:21 (2641 d 23:49 ago) Posting: # 16993 Views: 6,590 |
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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 ★★ Germany, 2017-01-23 14:32 (2641 d 22:38 ago) @ omprakash Posting: # 16994 Views: 5,901 |
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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 ☆ India, 2017-01-28 08:17 (2637 d 04:53 ago) @ Dr_Dan Posting: # 16997 Views: 5,504 |
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❝ … 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 ☆ Tamilnadu, India, 2017-02-04 13:58 (2629 d 23:13 ago) @ omprakash Posting: # 17012 Views: 5,360 |
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Dear Sir, The European Union guidelines adopted in Australia Primary PK Parameter: AUC0-t and Cmax Secondary PK Parameter: Tmax — Muthu Raj |
Helmut ★★★ Vienna, Austria, 2017-02-04 19:25 (2629 d 17:45 ago) @ Muthu Raj Posting: # 17013 Views: 5,523 |
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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). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Muthu Raj ☆ Tamilnadu, India, 2017-02-06 13:01 (2628 d 00:10 ago) @ Helmut Posting: # 17018 Views: 5,354 |
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Hi Sir, Thanks for this Information — Muthu Raj |