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Paresh ☆ 2011-03-18 08:07 (5582 d 02:48 ago) Posting: # 6771 Views: 3,819 |
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Hi, TGA follow the new updated guideline of EMEA, "GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE" Doc. Ref.: CPMP/QWP/EWP/1401/98 Rev. 1 For TGA need to follow old guideline approved in (January 2002, Doc. Ref.: CPMP/QWP/EWP/1401/98) or new EMEA updated guideline? Edit: Subject line changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2011-03-19 01:10 (5581 d 09:46 ago) @ Paresh Posting: # 6778 Views: 3,305 |
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Dear Paresh, what about the Guidelines on top of the page? The adopted Note for Guidance (April 2002) is still in force (see also European Union guidelines adopted in Australia > Clinical guidelines). The new European GL was in consultation end of June 2010 and was not mentioned ever since. Maybe dudes down under need so'more time.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Paresh ☆ 2011-03-21 12:22 (5578 d 22:34 ago) @ Helmut Posting: # 6785 Views: 3,225 |
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Thanks for reply, So need to keep AUC0-INF also as primary PK parameter (as per old EMEA Guideline), and need to prove 90% CI for AUC0-INF between 80.00 - 125.00% for Bioequivalence proof of the drug for TGA submission. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2011-03-21 14:57 (5578 d 19:58 ago) @ Paresh Posting: # 6788 Views: 3,235 |
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Dear Paresh! ❝ So need to keep AUC0-INF also as primary PK parameter (as per old EMEA ❝ Guideline), and need to prove 90% CI for AUC0-INF between 80.00 - 125.00% ❝ for Bioequivalence proof of the drug for TGA submission. Well, I haven't performed any studies specifically for TGA - but really a lot according to the old EU NfG. See Section 3.3: In bioequivalence studies the AUCt is the most reliable reflection of the extent of absorption. I never (!) had any problems performing the assessment for BE only on AUCt.Of course keeping in mind Section 3.1: The sampling schedule should be planned [...] to cover the plasma concentration time curve long enough to provide a reliable estimate of the extent of absorption. This is generally achieved if the AUC derived from measurements is at least 80% of the AUC extrapolated to infinity. What I did was:
— 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 |
Ing. Helmut Schütz